PHARMACEUTICAL PRESIDENTIAL 2016
| CONGRESS | SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness |
| Law No. 105/2016 / QH13 |
Hanoi, April 6, 2016
|
PHARMACEUTICAL LAW
Pursuant to the Constitution of the Socialist Republic of Vietnam;
The National Assembly promulgates the Pharmacy Law.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation and subjects of application
1. This Law provides for the State’s policies on pharmaceuticals and development of the pharmaceutical industry; practicing pharmacy; trading in pharmaceuticals; registration, circulation and withdrawal of drugs and raw materials for drug production; traditional medicines and medicines; prescription and drug use; drug information, pharmacovigilance and drug advertising; clinical pharmacy; To manage drugs in medical examination and treatment establishments; clinical trials and bioequivalence tests; Quality control of medicines, medicinal materials and drug price management.
2. This Law applies to domestic agencies, organizations and individuals as well as foreign organizations and individuals involved in pharmaceutical activities in Vietnam.
Article 2. Interpretation of terms
In this Law, the terms below are construed as follows:
1. Pharmaceuticals are drugs and materials for drug production.
2. Drugs constituting pharmaceuticals or medicinal substances for human use for the purposes of disease prevention, disease diagnosis, treatment, disease treatment, disease reduction and adjustment of physiological functions of the human body including pharmaco-chemical pharmaceuticals, medicines, traditional medicines, vaccines and biologicals.
3. Raw materials for drug production are ingredients used in the manufacture of medicines, including pharmaceuticals, pharmaceuticals, excipients and capsules used in the manufacture of drugs.
4. Pharmaceutical substances (also called active substances) are substances or mixtures of substances used for the production of drugs, which have pharmacological effects or have direct effects on disease prevention, disease diagnosis, treatment and treatment, mitigate the disease, regulate the physiological function of the human body.
5. Medicaments are raw materials for making medicines of natural origin from plants, animals, minerals and meeting the criteria for making drugs.
6. Pharmaceutical chemistry means a medicine containing ingredients already determined to be constituents, formulas, purity and up to the standards of medicine, including injected drugs extracted from materia medica, drugs with combination of pharmaceutical substances and other drugs. The drug has been shown to be safe and effective.
7. Medicinal herbs are drugs with ingredients from medicinal herbs and act on the basis of scientific evidence, except for traditional medicines prescribed in Clause 8 of this Article.
Traditional medicines (including traditional medicines) are medicaments which are processed, prepared or arranged according to theoretical and methodical knowledge of traditional medicine or folk experience into the formulation. Available in traditional or modern form.
9. Traditional medicine is a medicinal product processed according to the theories and methods of traditional medicine used for the production of traditional medicines or for disease prevention and treatment.
10. Bioproducts (also known as biological medicines) are drugs produced by technology or biological processes from substances or mixtures of biologically derived polymers, including derivatives of blood and plasma. people.
Biological products not included antibiotics, substances with low molecular biology can be isolated into pure and in vitro diagnostic reagents.
Reference biologicals (also referred to as reference biological drugs) are biologicals that are licensed for circulation in Vietnam on the basis of adequate data on quality, safety and efficiency.
12. Similar biological products (also called similar biological drugs) are biologically similar in quality, safety and efficacy to a reference biological drug.
13. Vaccines mean antigen-containing drugs which give the body the immune response capability used for disease prevention and treatment.
14. New drugs mean medicines containing new pharmaceutical substances or pharmaceuticals which are used for the first time in drugs in Vietnam; New combinations of endemic drugs or medicinal herbs used in Vietnam.
Generic drugs are drugs of the same substance, content, formulations with original and often used in place of the original drug.
16. The original prescription is the first medicine that is licensed for circulation on the basis of adequate data on quality, safety and effectiveness.
17. “Addictive drugs” means drugs containing narcotic stimulants or nerve-inhibiting drugs that cause addictions to users on the list of habit-forming drugs, promulgated by the Minister of Health.
18. Psychotropic drugs are drugs that contain narcotic stimulants or inhibitors or hallucinations, which, if repeatedly used, can lead to addictions for users on the list of psychotropic substances administered by the Minister. Ministry of Health.
19. Pre-emptive drugs mean drugs containing pre-substances on the list of medicines for use as medicines, promulgated by the Minister of Health.
20. Combined drugs containing narcotic drugs mean drugs with many active substances, including active narcotics with concentration and content prescribed by the Minister of Health.
21. Co-ordinated medications containing psychotropic substances are drugs with many active substances, including psychotropic substances with concentration and content prescribed by the Minister of Health.
22. Comprehensive drug containing pre-substance means a drug containing many pharmaceutical substances, including drug substances being precursors with concentration and content prescribed by the Minister of Health.
23. Radioactive drugs are drugs containing radioactive nuclear components for human use for the diagnosis and treatment of diseases, biomedical research including radioactive isotopes or radioactive isotopes attached to markers.
24. Radioisotope is the isotope of a chemical element whose atomic nucleus is unstable and emits ionizing radiation during decay to become a stable state.
25. Marking substances (also called conductors or carriers) are substances or mixtures used for preparation, which are attached to radioactive isotopes forming radioactive substances.
26. Medicines and drug materials subject to special control (hereinafter called special-controlled drugs for short) include:
a / Drugs specified in Clauses 17, 18, 19, 20, 21, 22, 23 and 24 of this Article;
b) Medicine raw materials being psychotropics, addictive substances, pre-substances used as drugs or radioactive substances for production of drugs prescribed in Clauses 17, 18, 19, 20, 21, 22, 23 and 24 of Article. this;
c) Toxic drugs and materials for production of drugs on the list promulgated by the Minister of Health;
d / Drugs and / or pharmaceuticals on the list of substances banned from use in a number of specific branches and domains according to the Government’s regulations.
27. Non-prescription drugs mean medicines for distribution, retail sale and use without prescriptions, which are on the list of non-prescription drugs promulgated by the Minister of Health.
28. Prescription drugs are drugs that, when distributed, used and sold, must be prescription drugs, if used in contravention of the prescription of the prescriber, can be dangerous to life and health.
29. Essential drugs are medicines that meet the health needs of the majority of people on the list of essential drugs promulgated by the Minister of Health.
30. Rare drugs are drugs for prevention, diagnosis, treatment of rare diseases or drugs not available under the regulations of the Minister of Health.
31. The drug’s life is the prescribed use duration for drugs after which the drug is not allowed to be used.
Shelf life of drugs is expressed by the period from the date of production to the expiry date or expressed by the day, month, year expired. In cases where the expiry date refers to the month and year, the expiry date shall be calculated up to the last day of the expiry month.
32. Drugs not up to quality standards mean drugs which fail to meet the quality standards already registered with competent state agencies.
33. Counterfeit medicines are medicines manufactured in one of the following cases:
a / Having no pharmaceutical ingredients;
b / Having drugs not in conformity with the drugs inscribed on the labels or according to the standards already registered for circulation or inscribed in the import permits;
c) There are pharmaceutical substances and materia medica but not in accordance with the content, concentration or volume already registered for circulation or inscribed in the import permits, except for drugs not up to the quality standards prescribed in Clause 32 of this Article in the process. storage, circulation and distribution;
d) Produced, presented or labeled to impersonate the manufacturer, country of origin or country of origin.
34. Pharmaceutical materials are medicaments in one of the following cases:
a / The species, part or origin is intentionally inscribed on the label or inscribed in the accompanying document;
b / It is deliberately mixed or replaced with non-medicinal ingredients inscribed on labels; Medicinal substances intentionally extracted active ingredients;
c) Produced, presented or labeled to impersonate the manufacturer, country of origin or country of origin.
35. The adverse reaction of the drug is an adverse reaction, which is harmful to health, which may occur at normal doses.
36. Pharmaceutical practice is the use of individuals’ professional qualifications to trade in pharmaceuticals and clinical pharmacology.
37. Good practice means the set of principles, standards for production, preservation, testing, circulation of drugs, prescription of drugs, clinical trials, aquaculture, collection of materia medica and norms and standards. Other standards promulgated by the Minister of Health or promulgated on the basis of the guidance of the World Health Organization or other international organizations to which Vietnam is a member or accredited.
38. Bioavailability is a property that expresses the rate and extent of the absorption of a drug or substance from a drug into the body so that the drug or substance that appears to be active in the body. .
39. Biological equivalence is the similarity of bioavailability between two drugs when compared under the same test conditions.
40. Clinical pharmacology is a scientific research and pharmacopoeia practice on the rational, safe and effective use of drugs in order to optimize the use of drugs.
41. Pharmacovigilance is the detection, evaluation, and prevention of adverse effects associated with drug use.
42. Direct contact with the drug is the package containing the drug, direct contact with the drug, formation of the block or encapsulation of the drug.
43. Pharmaceutical business means the performance of one, several or all stages of the investment process, from production to sale of products or providing services related to medicines and medicinal materials in the market. for profit purpose.
Article 3.- National reserve for drugs and raw materials for drug manufacture
1. The State shall effect the national reserve of drugs and raw materials for use in the following cases:
a / To prevent and combat epidemics and overcome the consequences of natural disasters and catastrophes;
b / Ensuring national defense and security;
c) Prevention, diagnosis and treatment of rare diseases;
d) The drug is not available.
2. The building, organization, management, administration and use of medicines and raw materials for drug production in national reserves shall comply with the provisions of law on national reserves.
Article 4.- The State management agency in charge of pharmacy
1. The Government shall perform the uniform State management over pharmacy.
2. The Ministry of Health shall take responsibility before the Government for exercising the State management over pharmacy.
3. Ministries and ministerial-level agencies shall, within the ambit of their respective tasks and powers, perform the State management over pharmacy and coordinate with the Health Ministry in performing the State management over pharmacy according to the Government’s assignment.
4. People’s Committees at all levels shall, within the scope of their tasks and powers, perform the State management over pharmacy in their localities.
Article 5.- Pharmacy Association
1. The Pharmaceutical Society is a social-professional organization operating in the field of pharmacy.
2. Organizations and individuals operating in the pharmaceutical domain shall have the right to participate in and set up pharmacy associations.
3. The organization and operation of the pharmacy association shall comply with the provisions of this Law and the law on associations.
4. The Pharmaceutical Society has the following responsibilities and powers:
a) To promulgate rules on professional ethics in pharmaceutical practice on the basis of the principle of virtue of pharmaceutical practice promulgated by the Minister of Health;
b / To participate in the formulation, organization and implementation of legal documents on pharmacy;
c / To participate in supervising the practice of pharmacy practice, the practice of pharmaceutical practice ethics and social-related activities related to pharmacy;
d / To participate in training and updating professional knowledge on pharmacy;
e) To join the Advisory Council for granting pharmaceutical practice certificates.
Article 6.- Prohibited acts
1. Trading in pharmaceuticals without certificates of eligibility for pharmaceutical business or during the period of suspension or during the time of deprivation of the right to use certificates of eligibility for pharmaceutical business.
2. Trading in pharmacies at places other than the registered pharmacy business places.
3. Trading in drugs and raw materials for production of drugs specified in Clause 26, Article 2 of this Law and other drugs and materials for use as drugs for wrong purposes or providing them not to the right subjects, which are granted by competent state management agencies. allowed
4. Trading in pharmaceuticals not falling within the professional scope inscribed in the certificates of eligibility for pharmaceutical business.
5. Trading in pharmaceuticals in one of the following cases:
a / Counterfeit drugs, raw materials for counterfeit medicines;
b / Drugs and raw materials for drug manufacture fail to meet quality standards; drugs and raw materials for drug manufacture, which have been recalled by the competent State bodies; drugs and raw materials for making drugs of unclear origin or origin; medicines, drug materials have expired;
c / Drugs and raw materials for manufacture of drugs on the list of drugs and raw materials for manufacture of medicines banned from import or production;
d) Clinical reagents;
e) Drugs and raw materials for making medicines for use as a model for registration, testing, scientific research or participation in display at exhibitions or fairs;
e) Drugs and drug materials not yet permitted for circulation;
g) Drugs belonging to national target programs, aid drugs and other drugs are not allowed to be sold;
h) Retailing prescription drugs without prescription; retail vaccines;
i / Selling drugs at prices higher than the declared prices and listed prices.
6. Forging, correcting dossiers, papers, documents and certificates of competent agencies and organizations as well as organizations and individuals engaged in pharmacy activities.
7. Change or modification of the drug’s expiry date, except for changes in the shelf life of drugs prescribed in Clause 3, Article 61 of this Law.
8. Practicing their profession without a pharmaceutical practice certificate or during the time of deprivation of the right to use pharmaceutical practice certificates at the positions prescribed in Article 11 of this Law.
9. Leasing, borrowing, leasing, lending or letting others use pharmaceutical practice certificates or certificates of eligibility for trading in pharmaceuticals for medical practice or trading.
10. Advertisement in the following cases:
a / Advertising drugs without the competent State management agency’s certification of contents or in contravention of the contents already certified;
b / Using certificates not yet recognized by the Health Ministry, using material interests, taking advantage of the names of organizations and individuals, symbols, images, positions, prestige, letters, letters thanks for advertising the drug;
c / Using clinical research results, preclinical research results, testing results and bioequivalence test results not yet recognized by the Ministry of Health for drug advertisement.
11. Sale of medicines in contravention of law provisions.
12. Taking advantage of drug prescription for self-seeking.
13. Production, preparation and sale of traditional medicines combined with pharmaceuticals without the permission of competent state management agencies.
14. To distribute or sell drugs which have expired use or preservatives in contravention of regulations on drug labels or drugs already notified by competent state agencies or drugs of unclear origin use.
Information, advertising, marketing, prescription, counseling, labeling and use instructions with contents for disease prevention and treatment, disease diagnosis, disease treatment, disease reduction and adjustment Human physiology for non-medicinal products, except medical equipment.
16. Export of pharmaceutical materials on the list of species and types of rare, precious and rare pharmaceuticals subject to control without permission of competent state management agencies.
CHAPTER II
STATE POLICIES ON PHARMACEUTICAL AND PHARMACEUTICAL INDUSTRIAL DEVELOPMENT
Article 7.- The State’s pharmaceuticals policy
1. To ensure the prompt and adequate supply of quality drugs and reasonable prices for the people’s disease prevention and treatment needs, suitable to the disease structure and requirements of national defense, security and epidemic prevention. disease, disaster recovery, disaster and rare drugs.
2. To ensure the rational, safe and efficient use of drugs; Prioritize the development of clinical pharmacology and pharmacovigilance.
3. Incentives for investment in the manufacture of drugs, raw materials for production of drugs, essential drugs, drugs for prevention and combat of social diseases, vaccines, biologicals, materia medica, traditional medicines and rare drugs; To give priority to scientific research into the technology of preparation and biotechnology for the production of new drugs.
4. For medicines purchased from the state budget, the health insurance fund, revenue from medical examination and treatment services and other lawful revenue sources of public medical establishments shall be as follows:
a / Failing to offer imported drugs on the list promulgated by the Health Minister based on the group of technical criteria when domestically manufactured medicines meet the requirements on treatment, drug prices and supply capacity.
To prioritize the purchase of domestically produced generic and / or biological medicines granted registration papers for circulation in Vietnam; Traditional medicines and medicines made from domestic materia medica; drugs using pharmaceutical ingredients, excipients, capsules or packages in direct contact with drugs produced by domestic establishments to meet the Good Manufacturing Practices; fresh medicinal herbs; Traditional medicines and medicines are produced on the basis of scientific and technological tasks at the national, ministerial or provincial level;
b / Failing to offer imported pharmaceutical materials on the list promulgated by the Health Minister when the medicines are cultured or collected domestically, meeting the requirements on treatment and supply capability and reasonable prices.
The Government shall provide for reasonable prices at this point;
c / Prioritizing the purchase of drugs on the list of national products.
5. To create favorable conditions for the order and procedures for filing applications for circulation of generic or soon-to-be-expired generic or patented generic drugs; To prioritize the order and procedures for circulation registration and grant of permits for import of rare drugs and vaccines already evaluated by the World Health Organization.
6. To combine state budget investment with the mobilization of other resources for the development of industries producing vaccines, biologicals, materia medica, traditional medicines, expired or patented drugs. offices; cultivating and producing medicinal herbs; To discover, preserve and apply scientific and technological advances in research and development of gene sources of precious and rare and endemic pharmaceuticals.
7. Supporting and facilitating the detection, clinical trial, registration for protection of intellectual property rights, registration for circulation and inheritance of traditional medicines and materia medica with scientific subjects; nationally, ministerial or provincial-level technologies already accepted; To search, exploit and use new medicinal herbs; export of medicinal herbs; Eating herbal medicine; exploit rational natural medicine; Studying, surveying and investigating species of medicinal herbs suitable for cultivation in localities; to develop medicinal herding areas; To modernize the production of materia medica, medicinal herbs and traditional medicines.
8. Having a policy of protection of confidentiality in the processing, processing and clinical trial data of traditional medicines; Reasonable treatment for the donor to the State quit traditional medicine; To create conditions for the granting of certificates of traditional medicine and / or pharmaceutical practice to owners of prescription remedies which are recognized by the Ministry of Health.
9. Encouraging the transfer of technology in the production of drugs; To develop a distribution network, a drugstore chain, preserve and supply medicine in a professional, modern and effective manner, ensuring the prompt and adequate supply of quality drugs to meet the demand for use. drugs of the people; Encourage pharmacies and drug stores to operate 24/24 hours.
To encourage investment in, and support the development of, drug supply systems and mobile drug retailing establishments for ethnic minority people and people in mountainous regions and islands and areas with special socio-economic conditions. hard.
10. Mobilization of medical establishments belonging to the people’s armed forces to participate in the supply of drugs and cultivation of pharmaceutical materials in order to meet the people’s demand for disease prevention and treatment in ethnic minority and mountainous areas, islands, areas with extremely difficult socio-economic conditions.
11. To adopt policies to raise the quality of pharmaceutical human resources; Priority in pharmaceutical practice for holders of pharmaceutical practice certificates in the form of examinations in accordance with the regulations of the Government.
Article 8.- Prioritized domains in the development of the pharmaceutical industry
1. To study the production of medicinal materials from the sources of materia medica available in Vietnam in service of the pharmaceutical industry and the manufacture of traditional medicines.
2. Production of medicines at the expiry of their respective patents or related monopolies, vaccines, biologicals, materia medica, materia medica, traditional medicines and rare drugs.
To develop sources of materia medica, medicinal plant breeding areas; To conserve genetic resources and develop species, rare and endemic species and species.
4. Forms of investment preferences and investment supports for priority domains for development of the pharmaceutical industry shall comply with the provisions of investment law.
Article 9.- Planning on development of the pharmaceutical industry
1. The planning on development of the pharmaceutical industry covers the planning on production, distribution, preservation and testing of drugs and raw materials for medicine production, development of medicinal materials for drug production and medicinal plants.
2. Planning on development of the pharmaceutical industry must satisfy the following requirements:
a / Being in line with the provisions of this Law and other relevant law provisions;
b / Being in line with the country’s socio-economic development strategy in each period; environmental protection and sustainable development;
c) Orientation, modernization and specialization;
d / Scientific forecasts, meeting practical requirements and compatibility with the development trend and international integration.
For plannings on development of production of materia medica, traditional medicines, traditional medicine and pharmaceutical raw material development plannings, apart from the provisions in Clause 2 of this Article, The following requirements:
a / To rationally exploit and use natural resources; It is suitable with the soil conditions, climate, ecology and natural and social conditions of each locality;
b / Orientations for production and processing of pharmaceutical materials on an industrial scale, development of medicinal herding zones, preservation of gene sources and development of rare and endemic species and species on the basis of increasing head Technical, advanced technology, combined with traditional experience.
4. The elaboration, approval and management of the planning on development of the pharmaceutical industry shall comply with the provisions of law.
Article 10.- Responsibilities in development of the pharmaceutical industry
1. The Ministry of Health has the following responsibilities:
a / To assume the prime responsibility for, and coordinate with concerned ministries, ministerial-level agencies and agencies attached to the Government in, promulgating according to its competence or submitting to competent authorities for promulgation and organizing the implementation of legal documents, Strategies, policies, planning and plans for development of the pharmaceutical industry;
b / To assume the prime responsibility for, and coordinate with the Ministry of Education and Training in, formulating plans on training and use of human resources for research and production of generic medicines, vaccines, bio-products, materia medica and traditional medicines. , rare drugs;
c / To assume the prime responsibility for, and coordinate with the Ministry of Natural Resources and Environment, the Ministry of Agriculture and Rural Development and concerned agencies in, planning the development of materia medica farming areas, organizing the application of conservation measures To maintain, exploit and use rational and sustainable sources of materia medica;
d / To assume the prime responsibility for, and coordinate with the Ministry of Agriculture and Rural Development and concerned ministries, ministerial-level agencies and agencies attached to the Government in, promulgating a list of species and types of precious and rare and endemic pharmaceuticals subject to inspection control.
2. The Ministry of Industry and Trade shall assume the prime responsibility for, and coordinate with concerned ministries, ministerial-level agencies and agencies attached to the Government in, promulgating according to its competence or submitting to competent authorities for promulgation and organizing the implementation thereof. Legal norms, planning and plans on development of the pharmaco-chemical industry.
3. The Ministry of Agriculture and Rural Development shall have the following responsibilities:
a / To assume the prime responsibility for, and coordinate with the Ministry of Health and the Ministry of Science and Technology in, scientific research into the selection, breeding, husbandry and collection of materia medica; Studying and disseminating techniques of farming, preventing and fighting diseases on medicinal plants and animals;
b / Assume the prime responsibility for, and coordinate with concerned ministries, ministerial-level agencies and government-attached agencies in, submitting to the Government for promulgation specific policies on breeds, capital and technologies in the development of aquaculture and exploitation of materia medica.
4. The Ministry of Natural Resources and Environment shall assume the prime responsibility for, and coordinate with concerned ministries, ministerial-level agencies and government-attached agencies in, submitting to the Government for promulgation policies on access to pharmaceutical gene sources and benefit sharing. Benefit from the use of medicinal gene sources.
5. The Ministry of Planning and Investment shall have the following responsibilities:
a / To allocate and balance resources for investment in the development of the pharmaceutical industry, mobilize foreign capital sources for the development of the pharmaceutical industry;
b / To assume the prime responsibility for, and coordinate with the Ministry of Finance and concerned ministries, ministerial-level agencies and agencies attached to the Government in, elaborating and promulgating competent regulations promulgating specific policies on investment preferences and support Investment aid in the pharmaceutical domain specified in Article 8 of this Law.
6. The Ministry of Finance shall have the following responsibilities:
a / To assume the prime responsibility for, and coordinate with concerned ministries, ministerial-level agencies and agencies attached to the Government in, formulating financial mechanisms, mobilizing and securing resources for the implementation of the planning and plans on development of the pharmaceutical industry. Submitted to competent authorities for approval;
b / To assume the prime responsibility for, and coordinate with the Ministry of Industry and Trade, the Ministry of Defense, the Health Ministry and the provincial-level People’s Committees of the localities where exist the border gates and border gates in, managing and controlling the import of drugs and raw materials for drug production. Circulation and import of pharmaceutical materials without permission of competent state agencies or export of pharmaceutical materials on the list of species and types of precious and rare pharmaceuticals which must be controlled.
7. The Ministry of Science and Technology has the following responsibilities:
a / To submit to competent authorities or allocate according to its competence annual state budget funds for scientific and technological activities to carry out research and put into application of research results in the manufacture of drugs. Particularly for drugs on the list of national products;
b / Assume the prime responsibility for, and coordinate with the Ministry of Agriculture and Rural Development and the Ministry of Health in, researching and preserving gene sources and developing sources of precious and rare and endemic pharmaceuticals;
c / To assume the prime responsibility for, and coordinate with the Ministry of Health in, formulating mechanisms and policies for protection of intellectual property with regard to traditional medicines.
8. Provincial-level People’s Committees have the following responsibilities:
a / To formulate and approve plannings and plans on development of pharmaceutical industry and development of materia medica (including exploitation and preservation of natural sources of materia medica) in localities in conformity with development plannings and plans national pharmaceutical industry, socio-economic development objectives and local advantages;
b / To allocate land fund for the construction of factories and pharmaceutical industrial zones; To prioritize the allocation of land for projects on development of medicinal herbs and medicinal herbs growing areas according to the provisions of the land legislation.
Chapter III
PHARMACEUTICAL PRACTICE
Section 1. CERTIFICATES OF PHARMACEUTICAL PRACTICE
Article 11.- The job placement must have a pharmaceutical practice certificate
1. Persons responsible for pharmaceutical expertise of pharmaceutical establishments.
2. Persons in charge of quality assurance of establishments producing drugs and raw materials for drug manufacture.
3. The person in charge of the clinical pharmacy work of the medical examination and treatment establishment.
Article 12.- Grant, re-grant or adjustment of contents of pharmaceutical practice certificates
1. The granting of pharmaceutical practice certificates shall be effected by mode of examination and approval to applicants or examination forms for persons in need and applicable to the following cases:
a / The applicant for the first pharmaceutical practice certificate;
b) Persons who have been granted pharmaceutical practice certificates but pharmaceutical practice certificates are withdrawn under the provisions of Article 28 of this Law.
In case of withdrawal of pharmaceutical practice certificates under Clauses 4, 6, 10 or 11, Article 28 of this Law, pharmaceutical practice certificates shall be granted only 12 months after the withdrawal.
2. Re-grant of pharmaceutical practice certificates for cases of loss or damage.
3. Adjustment of contents of pharmaceutical practice certificates shall apply to cases where persons who have been granted pharmaceutical practice certificates but change their practice scope or form of pharmaceutical practice certificates or information of persons granted Pharmaceutical practice certificate.
Article 13.- Conditions for grant of pharmaceutical practice certificates
1. Having diplomas, certificates and professional certificates (hereinafter referred collectively to as professional diplomas) granted or recognized in Vietnam suitable to their jobs and pharmaceutical business establishments, including:
a) University diploma of pharmacy (hereinafter referred to as pharmacy diploma);
b) University degree in general medicine;
c / Traditional university degree in traditional medicine or traditional pharmaceutical university;
d) Bachelor degree in biology;
e) Bachelor degree in chemistry;
e) Diploma of Pharmacy Diploma;
g) Intermediate degree in pharmacy;
h / Diplomas of colleges and medical colleges;
i / Diploma of intermediate degree in traditional medicine or traditional medicine;
j) Diploma and basic certificate of pharmacy;
l / A certificate of galenic physician’s identity, certificates of traditional medicine or certificates of traditional medicine or pharmacy certificates granted before the effective date of this Law.
The application of conditions on diplomas, certificates and certificates specified at Point l of this Clause shall be prescribed by the Minister of Health in line with the socio-economic development conditions and the demand for medical examination and treatment. The people in each locality in each period.
2. Having time for practicing at pharmacy establishments, pharmaceutical sections of medical examination and treatment establishments, specialized pharmacy training schools, pharmaceutical research establishments, medicine and drug testing establishments, the pharmaceutical management agency or the representative office of the foreign trader operating in the pharmaceutical domain in Vietnam (hereinafter referred collectively to as the pharmaceutical establishment); Medical examination and treatment establishments suitable to the professional qualifications of the practitioners shall comply with the following regulations:
a) With regard to the withdrawn pharmaceutical practice certificates as provided for in Clause 9, Article 28 of this Law, the practicing duration must not be required but must be updated with professional knowledge about pharmacy;
b / For persons with postgraduate qualifications suited to the scope of professional practice, their practicing duration shall be reduced according to the Government’s regulations;
c / For persons having professional diplomas specified at Point l, Clause 1, Article 13 of this Law, the practicing duration is prescribed by the Health Minister.
Having a health certificate for pharmaceutical practice issued by a competent medical establishment.
4. Not falling into one of the following cases:
a) Being examined for penal liability, serving court judgments or decisions; During the time of being banned from practicing the profession, banned from doing work related to pharmaceutical activities under court judgments or decisions;
b) Being restricted in civil act capacity.
5. For persons who voluntarily apply for the granting of pharmaceutical practice certificates in the form of an examination, they must fully satisfy the conditions prescribed in this Article.
Article 14.- Conditions for grant of pharmaceutical practice certificates in Vietnam to foreigners and overseas Vietnamese
1. Being fully qualified under the provisions of Article 13 of this Law.
2. Satisfying the requirements on the use of language in pharmaceutical practice as prescribed by the Minister of Health.
Article 15.- Conditions for persons responsible for pharmacy expertise and persons in charge of quality assurance of establishments manufacturing drugs and medicine materials
1. Conditions for persons responsible for pharmaceutical expertise of drug-manufacturing or -importing establishments being pharmaceuticals, adjuvants and capsules are prescribed as follows:
a / Persons responsible for pharmaceutical expertise of medicine-manufacturing establishments must possess the professional diplomas specified at Point a, Clause 1, Article 13 of this Law and have 5 years of professional practice at appropriate pharmaceutical establishments, minus cases prescribed at Point c of this Clause;
b / Persons responsible for pharmaceutical expertise of medicine raw materials-producing establishments being pharmaceuticals, adjuvants and capsules must possess the professional diplomas specified at Point a or Point e, Clause 1, Article 13 of this Law; 03 years of professional practice at the appropriate pharmacy;
c / Persons responsible for pharmaceutical expertise of establishments producing vaccines, biologicals and raw materials for production of vaccines and / or biologicals must possess one of the professional diplomas specified at Points a, b or d, Clause 1. Article 13 of this Law and having 05 years of professional practice at appropriate pharmacies.
2. Conditions for persons in charge of quality assurance of establishments manufacturing medicinal drugs and materials being drugs, medicinal herbs or capsules are prescribed as follows:
a / Persons in charge of quality assurance of medicine production establishments must possess the professional diplomas specified at Point a, Clause 1, Article 13 of this Law and have 5 years of professional practice at drug-manufacturing establishments. Drug testing laboratories, except for cases specified at Points b and c of this Clause;
b) The person in charge of quality assurance of the vaccine and / or biological vaccine production establishment must have one of the professional diplomas specified at Points a, b or d, Clause 1, Article 13 of this Law and have 5 years of practical experience. Specialized medical examinations at production establishments or testing of vaccines and medical bio-products;
c / Persons in charge of quality assurance of establishments producing medicinal materials being medicaments, adjuvants or capsules must possess the professional diplomas specified at Point a or Point e, Clause 1, Article 13 of this Law; Have 3 years of professional practice at medicine production establishments, raw materials for drug manufacture or drug testing establishments.
3. Conditions for persons responsible for pharmaceutical expertise and persons in charge of quality assurance of establishments manufacturing medicinal herbs are prescribed as follows:
a / Persons responsible for pharmacy expertise, persons in charge of quality assurance of pharmaceutical raw material-producing establishments must possess professional diplomas specified at Point a or c, Clause 1, Article 13 of this Law and 02 Professional practice at the appropriate pharmaceutical establishment, except for cases specified at Point b of this Clause;
b / Persons responsible for pharmacy expertise, persons in charge of quality assurance of business households or cooperatives engaged in medicinal herbs production must have one of the professional diplomas specified at Points a, c, g, i or l, Clause 1, Article 13 of this Law and have 2 years of professional practice at appropriate pharmaceutical establishments, except for cases prescribed at Point c, Clause 2, Article 13 of this Law;
c) The person in charge of pharmacy expertise may also concurrently be the person in charge of quality assurance of the pharmaceutical material-manufacturing establishment.
Article 16.- Conditions for persons responsible for pharmaceutical expertise of drug-wholesaling establishments and medicine raw materials
1. Persons who are professionally responsible for pharmacy shall have the professional diplomas specified at Point a, Clause 1, Article 13 of this Law and have 2 years of professional practice at the establishments. with the exception of cases specified in Clauses 2 and 3 of this Article.
2. Persons responsible for pharmaceutical expertise of vaccine and / or bio-product wholesalers must have one of the professional diplomas specified at Points a, b or d, Clause 1, Article 13 of this Law and have 2 years of actual Practice at the appropriate pharmacy.
3. Persons who are professionally or professionally engaged in pharmacy shall have one of the professional diplomas specified at Points a, c, i or l, Clause 1, Article 13 of the Regulation on medicine. This law and 2 years of professional practice at appropriate pharmaceutical establishments, except for the case specified at Point c, Clause 2, Article 13 of this Law.
Article 17.- Conditions on persons who are professionally responsible for pharmaceuticals of establishments importing or exporting drugs and raw materials for drug manufacture
1. Persons responsible for pharmaceutical expertise of establishments that export or import drugs and / or raw materials for production of drugs must possess the professional diplomas specified at Point a, Clause 1, Article 13 of this Law and have 2 years of professional practice. at the appropriate pharmaceutical establishments, except for the cases specified in Clauses 2 and 3 of this Article.
2. Persons responsible for pharmaceutical expertise of establishments that export or import vaccines and / or biologicals must have one of the professional diplomas specified at Points a, b or d, Clause 1, Article 13 of this Law and have 2 years of professional practice at the appropriate pharmacy.
3. Persons responsible for pharmaceutical expertise of establishments that export or import medicinal herbs, traditional medicines or traditional medicines must possess professional diplomas specified at Point a or c, Clause 1, Article 13 of this Law; 02 years of professional practice at the appropriate pharmacy.
Article 18 .- Conditions for persons responsible for pharmaceutical specialty of drug – retailing establishments
1. Persons who are professionally responsible for pharmaceuticals of pharmacies must possess the professional diplomas specified at Point a, Clause 1, Article 13 of this Law and have 2 years of professional practice at appropriate pharmacies. The person responsible for pharmacy expertise may also be a pharmacist at the pharmacy.
2. Persons responsible for pharmaceutical domain expertise must have one of the professional diplomas specified at Points a, f and g, Clause 1, Article 13 of this Law and have 18 months of professional practice at pharmaceutical establishments. fit.
3. Persons responsible for pharmacy specialties of commune medical ward medicine cabinets must have one of the professional diplomas specified at Points a, f, g or j, Clause 1, Article 13 of this Law and have one year of practice. The medical examination and treatment establishments at the appropriate pharmaceutical establishments or medical examination and treatment establishments; In cases where commune health stations in ethnic minority areas, mountainous areas, islands and areas with exceptionally difficult socio-economic conditions do not meet with one of the professional diplomas prescribed in Points a, e, g or j, Clause 1, Article 13 of this Law must have professional diplomas specified at Point b or h, Clause 1, Article 13 of this Law and have 01 year professional practice at medical establishments. , Healing.
4. Persons responsible for pharmaceutical expertise of establishments specialized in retailing pharmaceutical materials, materia medica and traditional medicines must have one of the professional diplomas specified at Points a, c, e, g, i or l. Clause 1, Article 13 of this Law and have one year of professional practice at pharmaceutical establishments or medical examination and treatment establishments using traditional medicine, except for cases specified at Point c, Clause 2, Article 13 of this Law.
Article 19.- Conditions for persons who are professionally responsible for pharmaceuticals of establishments providing medical examination and treatment services
1. Persons responsible for pharmaceutical expertise of establishments providing drug testing services and medicinal materials must possess the professional diplomas specified at Point a, Clause 1, Article 13 of this Law and have 3 years of specialized practice. at the appropriate pharmaceutical establishments, except for the case specified in Clause 2 of this Article.
2. Persons responsible for pharmaceutical expertise of establishments providing vaccine and bio-product testing services must have one of the professional diplomas specified at Points a, b or d, Clause 1, Article 13 of this Law and 03 years of professional practice at the appropriate pharmacy.
Article 20.- Conditions for persons who are professionally responsible for pharmaceuticals of clinics providing clinical trial services or bioequivalence tests of drugs
1. Persons who have professional responsibility for pharmacy of clinical trial drug-testing or bioequivalence testing establishments must possess the professional diplomas specified at Point a or b, Clause 1, Article 13 of the Law. and have 03 years of professional practice at the appropriate pharmacy or hospital or hospital with a hospital bed, except for the cases specified in Clause 2 of this Article.
2. Persons who are professionally responsible for pharmaceuticals of clinical trial and clinical drug service establishments shall have one of the professional diplomas specified at Point a. , b or c, Clause 1, Article 13 of this Law, and have 3 years of professional practice at the appropriate pharmaceutical establishment or hospital or hospital with a hospital bed.
Article 21.- Conditions for persons in charge of clinical pharmacy work of medical examination and treatment establishments
1. Persons in charge of clinical pharmacy work of medical examination and treatment establishments must possess the professional diplomas specified at Point a, Clause 1, Article 13 of this Law and have 2 years of professional practice at appropriate pharmaceutical establishments. or a hospital or hospital with a hospital bed, except for the case specified in Clause 2 of this Article.
2. Persons in charge of clinical pharmacy work of medical examination and treatment establishments using traditional medicine must possess the professional diplomas specified at Point c, Clause 1, Article 13 of this Law and have 2 years of professional practice at Hospitals, institutes with beds have traditional medicine activities.
Article 22 .- Conditions for persons who are professionally responsible for pharmaceuticals of establishments providing drug storage and / or preservation services
1. Persons responsible for pharmaceutical expertise of drug service and medicine preservation service establishments must possess the professional diplomas specified at Point a, Clause 1, Article 13 of this Law and have 2 years of professional practice. at the appropriate pharmaceutical establishments, except for the case specified in Clause 2 of this Article.
2. Persons responsible for pharmacy expertise of establishments providing vaccine preservation and biological preservation services must have one of the professional diplomas specified at Points a, b or d, Clause 1, Article 13 of this Law. 02 years of professional practice at the appropriate pharmacy.
Article 23.- Competence to grant, re-grant, adjust contents and withdraw certificates of pharmaceutical practice
1. Directors of provincial / municipal Health Services shall grant, re-grant, adjust contents and withdraw pharmaceutical practice certificates in the form of ratification.
The directors of the provincial / municipal Health Services shall set up councils for granting pharmaceutical practice certificates with the participation of the pharmacy associations’ representatives in order to advise the directors of the provincial / municipal Health Services on the grant, re-grant and withdrawal of pharmaceutical practice certificates. .
2. The Health Ministry shall grant pharmaceutical practice certificates in the form of examinations.
Article 24. Dossiers of application for pharmaceutical practice certificates
1. An application for a pharmaceutical practice certificate with a portrait of the applicant who is taken within a period of no more than 6 months.
2. A certified copy of the professional diploma.
3. A health certificate for pharmaceutical practice issued by a competent medical establishment.
4. A certificate of professional practice time granted by the head of the establishment where he / she has practiced.
5. Certificate of completion of the program on training and updating of professional knowledge on pharmacy in cases where the pharmaceutical practice certificates have already been withdrawn as provided for in Clause 9, Article 28 of this Law.
6. Certified copy of citizen identification, identity card or passport.
7. Judicial record card. For foreigners and Vietnamese residing abroad, they must have a judicial record or a document certifying that they are not currently offenders or examined for penal liability, which are not banned from practice. , to prohibit the performance of jobs related to pharmaceutical activities under court judgments or decisions granted by foreign competent agencies.
8. In cases where pharmaceutical practice certificates are withdrawn according to the provisions of Clause 3, Article 28 of this Law, the applicants for pharmaceutical practice certificates shall only have to file applications according to the provisions of Clause 1 of this Article.
Article 25.- Dossiers of application for re-grant of pharmaceutical practice certificates
1. An application for re-grant of a pharmaceutical practice certificate contains a portrait of the applicant who is arrested within 6 months.
2. Copies of the granted pharmaceutical practice certificates, if any, must be committed by the applicants.
Article 26. Dossiers of request for adjustment of contents of pharmaceutical practice certificates
1. An application for adjustment of the contents of a pharmacy practice certificate with portraits of the applicant shall be taken within 6 months.
2. Copies of papers evidencing the changes.
3. A copy of the granted pharmaceutical practice certificate.
Article 27.- Procedures for grant, re-grant or adjustment of contents of pharmaceutical practice certificates
1. Applicants for pharmaceutical practice certificates shall submit dossiers to the pharmaceutical certificate-granting bodies.
Within 20 days after receiving complete dossiers of application for grant; Within 10 days after receiving complete dossiers of application for re-grant or adjustment of contents of pharmaceutical practice certificates, the heads of the pharmaceutical practice certificate-granting bodies shall grant pharmaceutical practice certificates. In case of refusal to grant certificates, they must reply in writing and clearly state the reasons therefor.
2. The time limit for grant of pharmaceutical practice certificates under the provisions of Clause 8, Article 24 of this Law is 5 working days after the receipt of the written requests.
Article 28.- Cases of withdrawal of pharmaceutical practice certificates
1. Pharmaceutical practice certificates are granted ultra vires.
2. The certificate grantees shall withdraw their pharmaceutical practice certificates.
3. Pharmaceutical practice certificates are wrongly recorded at the fault of the pharmaceutical certificate-granting agency.
4. Falsification of papers in dossiers of application for pharmaceutical practice certificates.
Individuals who have 02 or more pharmaceutical practice certificates.
6. Persons practicing certificates shall lease, lend, rent, borrow or let others practice the pharmaceutical practice certificates.
7. Persons who have been granted pharmaceutical practice certificates do not meet one of the conditions for being granted pharmaceutical practice certificates as provided for in Article 13 or Clause 2, Article 14 of this Law.
8. Persons who have been granted pharmaceutical practice certificates for 12 consecutive months.
9. Pharmacy practitioners have no certificate of completion of the training program or update of professional knowledge on pharmacy within 3 years after being granted pharmaceutical practice certificates or from the date of receiving the written certification of reimbursement. Make training programs, update the knowledge about the nearest pharmacy.
10. Violating professional ethics in pharmaceutical practice, causing serious consequences to human life or serious consequences.
11. Being administratively sanctioned in form of depriving the pharmaceutical practice certificate of 02 times or more for one act of violation.
Article 29.- Management of pharmaceutical practice certificates
1. Each individual shall be granted only one pharmaceutical practice certificate. The pharmaco-professional practice certificate shall fully state the scope of professional practice which the pharmaceutical practice certificate holder meets the conditions and is permitted to practice. Pharmaceutical practice certificates shall not be valid and valid throughout the country.
The pharmaceutical practice certificate expires when the practitioner dies or disappears under the decision,
the court’s judgment or the certificate of completion of training or updating of professional knowledge on pharmacy within 3 years from the date of being granted the pharmaceutical practice certificate or the certificate of completion of the chapter The latest training, updating knowledge about pharmacy.
2. The recognition of pharmaceutical practice certificates between countries shall comply with the provisions of international agreements to which Vietnam is a party or treaties to which the Socialist Republic of Vietnam is a contracting party.
3. Basic contents of pharmaceutical practice certificates include:
a / Personal information of pharmaceutical practitioners;
b) Professional degrees;
c / Forms of professional practice;
d / Scope of professional activities;
e / Forms of granting pharmaceutical practice certificates by mode of examination or form of examination; Exam time in case of granting in the form of examination;
e) Date of issue, issuing authority, date of entry into force.
4. The Government shall detail the dossiers; The procedures for granting, re-granting, adjusting contents, withdrawing and formulation of pharmaceutical practice certificates; training establishments, programs, contents and duration of training and updating of professional knowledge on pharmacy; standardize professional qualifications and professional titles; Forms of certification of completion of training and updating of professional knowledge on pharmacy; a form of certification of practicing duration and appropriate professional practice; Practical time for persons with postgraduate qualifications; The granting of pharmaceutical practice certificates shall take the form of examination.
ITEM 2. RIGHTS AND OBLIGATIONS OF PHARMACEUTICAL PRACTICE
Article 30.- Rights of pharmaceutical practitioners
1. To be trained, updated knowledge, exchange of professional information and law on pharmacy.
2. To be granted pharmaceutical practice certificates when fully satisfying the conditions prescribed in this Law.
3. Persons responsible for their professional pharmacy business shall be entitled to authorize holders of appropriate pharmaceutical practice certificates when they are absent to take professional responsibility according to regulations.
4. The person in charge of the pharmacy’s specialized pharmacy shall be entitled to replace the drug already inscribed in the prescription with another medicine having the same active ingredient and its use and dosage with the purchaser’s consent and be responsible for change of medicine.
5. To refuse to conduct professional activities in contravention of law provisions or professional ethics.
Article 31.- Obligations of the pharmaceutical practitioner
1. Complying with professional ethics in pharmaceutical practice.
2. Persons responsible for professional activities of drug-retailing establishments must be present throughout the operation duration of pharmaceutical establishments, except for cases of authorization in their absence according to the provisions of Clause 3, Article 30 of this Law.
3. Only take professional responsibility for a pharmacy business establishment and at a pharmacy trading place.
4. Practicing pharmaceutical practice strictly according to the scope of professional activities inscribed in pharmaceutical practice certificates and professional technical regulations.
5. To abide by decisions of competent state agencies in case of dangerous epidemics, natural disasters or catastrophes.
6. Completing the program on training and updating of professional knowledge on pharmacy within 3 years from the date of being granted the pharmaceutical practice certificate or from the date of obtaining the certificate of completion of the training program The most recent pharmaceutical expertise.
7. To notify competent pharmaceutical agencies or persons of law-breaking acts and ethics of pharmaceutical practitioners of other pharmaceutical practitioners and take responsibility for the information already notified.
Chapter IV
PHARMACEUTICAL TRADING
SECTION 1. PHARMACEUTICALS AND PHARMACEUTICAL TRADING CONDITIONS
Article 32.- Activities of trading in pharmaceuticals and pharmacy establishments
1. Drug trading activities include:
a / Trading in drugs and raw materials for drug manufacture;
b / Providing services of preserving drugs and raw materials for drug production;
c / Providing services of testing drugs and raw materials for drug production;
d / Providing clinical trial drug services;
e / Trading in bioequivalence testing services of drugs.
2. Drug trading establishments include:
a) Establishments producing drugs and raw materials for drug production;
b / Establishments exporting and / or importing drugs and raw materials for drug production;
c / Establishments providing drug and medicine preservation services;
d / Establishments wholesaling drugs and raw materials for drug manufacture;
e / Drug-retailing establishments include drugstores, drugstores, commune medicine clinics, specialty retailers of materia medica, materia medica, traditional medicines;
e) Establishments providing drug testing services, drug materials;
g) Establishments providing clinical trial services;
h) Establishments providing services of bioequivalence testing of drugs.
Article 33.- Conditions for grant of certificates of satisfaction of pharmaceutical trading conditions
1. Conditions on material foundations, techniques and personnel are prescribed as follows:
a / Establishments manufacturing drugs and medicinal materials must have locations, production workshops, testing rooms, drug preservation warehouses, raw materials for drug manufacture, auxiliary systems, testing and preserving drugs, quality management systems, professional technical documents and personnel to meet the good practice of manufacturing drugs and raw materials for drug production;
b / Establishments that import drugs, raw materials for manufacture of medicines, establishments that export drugs and raw materials for drug manufacture, establishments providing drug and drug preservation services must have warehouses and drug stores. transportation, quality management system, technical documents and personnel to meet the good practice of preserving drugs and raw materials for drug production;
c / Establishments wholesaling medicines and medicinal materials must have medicine storage locations, warehouses, preservation equipment, means of transport, quality management systems, professional technical documents and personnel. good practice distribution of drugs and raw materials for drug production;
d / Drug-retailing establishments must have locations, preservation areas, preservation equipment, professional technical documents and personnel to meet the good practice of drug retail establishments; For establishments specialized in retailing pharmaceutical materials, materia medica and traditional medicines, the provisions of Point b, Clause 2, Article 69 of this Law shall apply.
e / Establishments providing drug testing service or drug materials must have locations, chemical or microbiological examination rooms, support systems, testing equipment, chemicals, reagents, quality management system, technical and personnel documentation to meet the good laboratory practice for quality control;
e / Clinical drug testing service establishments must have locations, clinical testing laboratories, laboratory rooms, biochemical testing equipment, quality management systems, technical and personnel documents. Good Clinical Practice Trial Response;
g) Business establishments providing bioequivalence testing services for drugs must have locations, laboratories for biological epidemiology analysis, laboratory equipment used in bio-epidemiological analysis, accommodation and follow-up. use of drugs for bioequivalence assessment, quality management systems, professional and technical documentation, and personnel meeting the Good Laboratory Practice for the Phase Bacterial Analysis and Practice Good clinical trial for the clinical study stage.
In cases where the bioequivalence testing service of a medicine only meets the good laboratory practice for biological fluid analysis, it must sign a contract or link it with the clinic to meet the actual demand. Good clinical trials to perform clinical trials in bioequivalence trials.
2. Persons who have the professional responsibility for pharmacy and the positions prescribed in Article 11 of this Law must possess the pharmaceutical practice certificates suitable to the pharmacy business establishments prescribed in Clause 2, Article 32 of this Law.
3. The evaluation of satisfaction of the material, technical and human resource conditions prescribed in Clause 1 of this Article shall be effected every three years or irregularly according to the Health Minister’s regulations or international treaties. of which the Socialist Republic of Vietnam is a member.
Article 34.- Business conditions for drugs subject to special control and drugs on the list of those restricted from retail
1. Drug trading establishments subject to special control must be approved in writing by the competent pharmaceutical State management agencies. Approval is based on the following conditions:
a) Satisfying the conditions specified in Article 33 of this Law suitable to the conditions of each business establishment;
b) To take security measures, ensuring that no drug or drug materials are subject to special control;
c) In cases where radioactive drugs must be traded, the conditions specified in the Law on Atomic Energy and other relevant legal documents must be met.
2. Medicine retailing establishments which sell drugs on the list of those restricted from retail shall have to fully meet the conditions prescribed at Point d, Clause 1, Article 33 of this Law and be approved by the Health Services. Written consent. The approval is based on the structure of disease and the ability to supply drugs in the province or city under the Central Government under the guidance of the Minister of Health.
3. The Government shall stipulate the order and procedures for allowing the trading of drugs subject to special control and drugs on the list of drugs restricted from retail; Measures on security, ensuring non-leakage of drugs and drug materials must be controlled.
Article 35.- Establishments conducting pharmaceutical activities not eligible for the granting of certificates of eligibility for pharmaceutical business
1. Establishments conducting pharmaceutical activities not eligible for the certificates of eligibility for pharmaceutical business include:
a) Establishments conducting pharmaceutical activities but not for commercial purposes;
b) Business establishments having drug shelves;
c) Establishments for raising and collecting medicinal herbs;
d / Medical establishments belonging to the people’s armed forces engaged in drug supply activities in ethnic minority, mountainous and island areas and areas meeting with exceptional socio-economic difficulties.
2. The operating conditions of establishments mentioned in Clause 1 of this Article are prescribed as follows:
a / The establishments defined at Point a, Clause 1 of this Article must comply with the business conditions specified in Clause 1, Article 33 of this Law;
b) Establishments specified at Point b, Clause 1 of this Article must be establishments having business registration and conditions for preservation of medicines suitable to preservation conditions inscribed on drug labels and persons having professional responsibility in writing It is permitted to sell drugs on the list of drugs sold at drug shelves prescribed by the Minister of Health;
c / Establishments engaged in aquaculture and / or gathering medicinal herbs must abide by good practice on aquaculture and / or gathering medicinal herbs;
d / The establishments defined at Point d, Clause 1 of this Article must have conditions for preservation of medicines in conformity with the preservation conditions inscribed on drug labels and have professional responsible persons who have professional diplomas of primary or higher degree.
3. The Minister of Health shall detail this Article.
Item 2. CERTIFICATE OF QUALIFICATION FOR PHARMACEUTICAL BUSINESS
Article 36.- Grant, re-grant or adjustment of certificates of eligibility for pharmaceutical business
1. To grant certificates of satisfaction of pharmaceutical trading conditions in the following cases:
a / The basis of the first-time request;
b / Establishments which have been granted certificates of satisfaction of pharmaceutical trade conditions but changed the form of pharmaceutical business establishments or changed the scope of pharmaceutical business, thus changing business conditions; relocation of pharmacy business locations;
c) Establishments which have been granted certificates of full satisfaction of pharmaceutical business conditions but have been withdrawn under the provisions of Article 40 of this Law.
2. Re-grant of certificates of satisfaction of pharmaceutical trading conditions in the following cases:
a / The certificate of full satisfaction of pharmaceutical business conditions is lost or damaged;
b / The information inscribed on the certificates of satisfaction of pharmaceutical business conditions is misleading due to the fault of the agency granting the certificate of full satisfaction of pharmaceutical business conditions.
3. To amend the certificate of eligibility for pharmacy business in case of a change in the name of the establishment, business address, professional manager or change of the pharmaceutical business scope without changing the business conditions. pharmacy.
Article 37.- Competence to grant, re-grant, adjust and withdraw certificates of eligibility for pharmaceutical business
1. The Minister of Health shall grant, re-grant, adjust and withdraw certificates of eligibility for pharmaceutical business, for pharmaceutical-trading establishments defined at Points a, b, c, f, g and h of Clause 2 Article 32 of this Law.
2. The directors of provincial / municipal Health Services shall grant, re-grant, adjust and withdraw certificates of eligibility for pharmaceutical business, for pharmacy business establishments defined at Points d and dd, Clause 2, Article 32 of this Law.
Article 38. Dossiers of application for grant, re-grant or adjustment of certificates of eligibility for pharmaceutical business
1. A dossier of application for a certificate of eligibility for pharmaceutical business, for cases specified at Points a and c, Clause 1, Article 36 of this Law, comprises:
a / An application for a certificate of qualification for pharmaceutical business;
b / Technical documents corresponding to pharmaceutical business establishments defined in Clause 2, Article 32 of this Law;
c / A certified copy of the enterprise registration certificate or legal documents evidencing the establishment of the establishment;
d / A certified copy of the pharmaceutical practice certificate.
2. A dossier of application for a certificate of eligibility for pharmaceutical business, for cases specified at Point b, Clause 1, Article 36 of this Law, comprises:
a / An application for a certificate of qualification for pharmaceutical business;
b / Technical documents relevant to changing business conditions;
c / A certified copy of the enterprise registration certificate or legal documents evidencing the establishment of the establishment;
d / A certified copy of the pharmaceutical practice certificate.
3. A dossier of application for re-grant of a certificate of full satisfaction of pharmaceutical business conditions comprises:
a) An application for re-grant of a certificate of full satisfaction of pharmaceutical business conditions;
b / The certificate of full satisfaction of pharmaceutical business conditions is misleading due to the fault of the issuing agency, for cases prescribed at Point b, Clause 2, Article 36 of this Law.
4. A dossier of request for adjustment of a certificate of eligibility for pharmaceutical business comprises:
a / An application for adjustment of the certificate of eligibility for pharmaceutical business;
b / A certified copy of the pharmaceutical practice certificate, for cases of relocation of work requiring the practice certificate;
c / A certified copy of the enterprise registration certificate or legal document evidencing the change in the name or address of the establishment.
5. The Government shall detail this Article.
Article 39.- Procedures for grant, re-grant or adjustment of certificates of eligibility for pharmaceutical business
1. Dossiers of application for grant, re-grant or adjustment of certificates of satisfaction of pharmaceutical business conditions shall submit to competent agencies defined in Article 37 of this Law.
2. Within 30 days after receiving complete dossiers of application for grant; Within 20 days after receiving complete dossiers of application for re-grant or adjustment, the Health Minister or directors of provincial / municipal Health Services shall organize the evaluation and grant of certificates of eligibility for pharmaceutical business according to their competence; In case of refusal to grant certificates, they must reply in writing and clearly state the reasons therefor.
In case of re-issue due to the fault of the agency that granted the certificate of satisfaction of pharmaceutical business conditions, the applicant for the certificate of satisfaction of pharmaceutical business conditions shall submit a dossier as prescribed in Clause 3, Article 38 of this Law. The time limit for re-grant of certificates of full satisfaction of pharmaceutical business conditions is 07 working days after the full receipt of dossiers.
Article 40.- Cases of revocation of certificates of eligibility for pharmaceutical business
1. Termination of pharmaceutical business activities.
2. Failing to meet one of the conditions for the grant of certificates of full satisfaction of pharmaceutical business conditions prescribed in Articles 33 and 34 of this Law.
3. A certificate of full satisfaction of pharmaceutical business conditions is granted, but not ultra vires or with contents contrary to law.
4. Not operating for 12 consecutive months without informing the State management agency in charge of pharmacy.
Article 41.- Management of certificates of satisfaction of pharmaceutical trading conditions
1. A certificate of full satisfaction of pharmaceutical business conditions does not stipulate the effective date.
2. The Government shall stipulate in details the following contents:
a / Dossiers and procedures for grant, re-grant, adjustment and withdrawal of certificates of eligibility for pharmaceutical business;
b / The geographical areas and scope of business of retail establishments include drug counters and commune medicine cabinets;
c / The roadmap for good practice of the pharmaceutical business establishment.
SECTION 3. RIGHTS AND RESPONSIBILITIES OF PHARMACEUTICAL ESTABLISHMENTS
Article 42.- Rights and responsibilities of drug-dealing establishments
1. Pharmaceutical business establishments have the following rights:
a / Conducting one, several or all pharmaceutical business activities if satisfying all conditions corresponding to each type of business establishment as provided for by this Law;
b / To enjoy preferential policies when conducting pharmaceutical business activities according to the provisions of law;
c / To advertise and advertise drugs according to the provisions of law;
d / To provide free drug support programs to medical examination and treatment establishments for treatment of patients according to the Health Minister’s regulations;
e / Organizing mobile drug retailing establishments in ethnic minority, mountainous and island areas and areas meeting with exceptional socio-economic difficulties as provided for by the Government.
2. Drug trading establishments shall have the following responsibilities:
a / Having certificates of eligibility for pharmaceutical business and trading only in the right form of business establishment, business scope and location stated in the certificate of full satisfaction of pharmaceutical business conditions;
b) To ensure the maintenance of pharmaceutical business conditions in the course of business activities according to the provisions of this Law;
c) To withdraw drugs and raw materials for drug manufacture under the provisions of Article 62 of this Law;
d) To pay compensations to damage caused to organizations and individuals by their faults according to the provisions of law;
e / To abide by decisions of competent state agencies in case of supply of medicines and raw materials for production thereof when dangerous epidemics, natural disasters or catastrophes occur;
e) To report to the Ministry of Health or the Health Service and fulfill the obligations prescribed by law in case of temporary cessation of operation of 06 months or more or termination of operation;
g / To notify and update the list of persons having their practicing certificates practiced at grassroots level to competent agencies as prescribed by the Health Minister;
h) To post up publicly the pharmaceutical practice certificates and certificates of satisfaction of pharmaceutical business conditions at business establishments;
i / Annual reports and reports at the request of competent pharmaceutical management agencies;
k) Comply with regulations of the Ministry of Health in the purchase and sale of drugs on the list of drugs restricted to retail;
l) To post up wholesale and retail prices in Vietnam dong at transaction places or drug sellers of pharmacy-trading establishments so as to facilitate the observation and recognition of customers and competent management agencies; Complying with other regulations on drug price management;
m) To keep vouchers and documents related to each batch of medicines or raw materials for drug manufacture for at least one year from the date the drugs or raw materials for drug production expire;
n) Preserving drugs and raw materials for production thereof according to conditions inscribed on labels;
o) To clearly state the names of drugs, contents and expiry dates for users in case of retail sale of drugs not included in the outer packagings of drugs; In case of no prescription, additional dosage, number of doses and method of administration should be added;
p) Prescription drugs may only be sold at drug retailers upon prescription.
3. Apart from the responsibilities prescribed in Clause 2 of this Article, drug trading establishments subject to special control shall have the following responsibilities:
a / Periodical reports; export and import reports; Report at the request of the competent management agency;
b / To compile dossiers and keep vouchers and relevant documents for each kind of drug and medicine material according to the regulations of the Ministry of Health.
Article 43.- Rights and responsibilities of establishments producing drugs and raw materials for drug manufacture
1. Establishments producing drugs and raw materials for production of drugs shall have the following rights:
a / The rights specified in Clause 1, Article 42 of this Law;
b / Research and trial production; Production of drugs and raw materials for drug production; franchise and franchise; Processing and processing of drugs and raw materials for drug production;
c / Registration for circulation of drugs and raw materials for drug production; Transfer of ownership of certificates of circulation of drugs and raw materials for drug manufacture; Request the withdrawal of registration papers for circulation of drugs and raw materials for drug production which they produce; Requesting the withdrawal of drugs and raw materials for drug production under the provisions of this Law;
d) Importing and purchasing medicinal materials for production; Importing drugs and raw materials for drug production in service of research, testing and use as registration forms for medicine circulation by establishments;
e / Selling raw materials for drug manufacture already imported for drug production of such establishments to other medicine-producing establishments;
e) Wholesale of medicines and medicinal materials for drug wholesalers and retailers and medical examination and treatment establishments;
g) Export of drugs and drug materials specified in Clauses 4 and 5, Article 60 of this Law.
2. Establishments producing medicinal drugs and materials shall have the following responsibilities:
a / The concerned responsibilities prescribed at Points a, b, c, d, e, g, h, i, j, l, m and n, Clause 2, Article 42 of this Law;
b / Producing drugs and raw materials for production thereof according to the production process and quality standards already registered or promulgated;
c / To bear responsibility for the origins and quality of drugs and raw materials for production of medicines and be allowed to export only medicines and medicine raw materials up to quality standards already registered;
d / To monitor the quality, safety and efficiency of drug and drug materials produced by the production establishments during the time of market circulation and recall of medicines and raw materials for production thereof according to the provisions of this Law;
e / To take responsibility for the quantity of medicines and raw materials for the production thereof already imported, purchased, sold, used and reported according to the Health Minister’s regulations.
Article 44.- Rights and responsibilities of drug-exporting or -importing establishments
1. Establishments exporting and / or importing drugs and raw materials for production thereof shall have the following rights:
a / The rights specified at Points a, b, c and d, Clause 1, Article 42 of this Law;
b) Importing drugs and raw materials for medicine as prescribed in Article 60 of this Law;
c / Registration for circulation of drugs and raw materials for drug production; Transfer of ownership of certificates of circulation of drugs and raw materials for drug manufacture; Request the withdrawal of registration papers for circulation of drugs and raw materials for drug manufacture; Requesting the withdrawal of drugs and raw materials for drug production under the provisions of this Law;
d / Selling medicines and imported drug materials to wholesale or retail establishments, drug-producing establishments and medical examination and treatment establishments. In cases where the right to distribute drugs in Vietnam can not be exercised, the import or export establishments may sell drugs or raw materials thereof for import drug production according to the Health Minister’s regulations;
e / Export of drugs and drug materials specified in Clauses 4 and 5, Article 60 of this Law.
2. Establishments for export and / or import of drugs and raw materials for drug production shall have the following responsibilities:
a / Responsibilities prescribed at Points a, b, c, d, e, g, h, i, j, l, m and n, Clause 2, Article 42 of this Law;
b / To take responsibility for the quantity and quality of drugs and raw materials for production of medicines issued by importing and exporting establishments and reporting them according to the Health Minister’s regulations.
Article 45.- Rights and responsibilities of establishments providing drug storage and / or preservation service establishments
1. Establishments providing medicine and medicine preservation services shall have the following rights:
a / The rights specified at Points a, b and c, Clause 1, Article 42 of this Law;
b / Preserving drugs and raw materials for production of drugs for organizations and individuals;
c / Export of drugs and drug materials specified in Clauses 4 and 5, Article 60 of this Law.
2. Establishments providing drug storage and / or preservation drug service businesses shall have the responsibilities specified at Points a, b, c, d, e, f, g, h, i, m and n, Clause 2, Article 42 of this Regulation. This law.
Article 46.- Rights and responsibilities of wholesale establishments of medicines and raw materials for drug manufacture
1. Establishments wholesaling drugs and raw materials for drug production shall have the following rights:
a / The rights specified in Clause 1, Article 42 of this Law;
b / Wholesale of medicines and medicine materials;
c / Purchasing drugs and raw materials for drug production;
d / Registration for circulation of drugs and raw materials for drug manufacture; Transfer of ownership of certificates of circulation of drugs and raw materials for drug manufacture; Request the withdrawal of registration papers for circulation of drugs and raw materials for drug manufacture; Requesting the withdrawal of drugs and raw materials for drug production under the provisions of this Law;
e / Export of drugs and drug materials specified in Clauses 4 and 5, Article 60 of this Law.
2. Establishments wholesaling drugs and raw materials for drug production shall have the following responsibilities:
a / Responsibilities prescribed at Points a, b, c, d, e, g, h, i, j, l, m and n, Clause 2, Article 42 of this Law;
b / Ensuring the delivery, receipt and preservation of drugs and drug materials must be undertaken by persons with professional qualifications.
Article 47.- The rights and responsibilities of retail establishments are pharmacies
1. Retail establishments being pharmacies have the following rights:
a / The rights specified at Points a, b, c and e, Clause 1, Article 42 of this Law;
b) Purchasing raw materials for making prescription-based medicines and selling drugs at establishments. The pharmacy professional manager of the pharmacy shall have to directly manage the preparation of medicines at the establishments;
c) Purchasing drugs for retail sale, except for vaccines; In case of purchase and sale of drugs subject to special control and drugs on the list of medicines restricted from retail sale, the provisions of Article 34 of this Law shall apply.
d / To participate in the issuance of drugs of insurance, medical programs or projects when meeting the requirements and conditions of such insurance, programs or projects;
e / The pharmacy diploma holder shall substitute the drug already prescribed in the prescription with another drug of the same active ingredient, route and dosage with the consent of the purchaser and take responsibility for the change.
2. Retail establishments being pharmacies have the following responsibilities:
a / Responsibilities prescribed in Clause 2 of Article 42 and Clause 2 of Article 81 of this Law;
b) To ensure conditions for the preparation of medicines according to the Health Minister’s regulations;
c / Not to sell medicine materials, except for pharmaceuticals.
Article 48.- Rights and responsibilities of retail establishments are drug counters
1. Retail establishments being drug stands have the following rights:
a / The rights specified at Points a, b, c and e, Clause 1, Article 42 of this Law;
b / Purchasing and retailing drugs on the list of essential drugs and the list of drugs without prescription, except for vaccines; In case of purchase and sale of drugs on the list of drugs subject to special control and the list of medicines restricted from retailing, the provisions of Article 34 of this Law shall apply. For drug counters in ethnic minority areas, mountainous areas, islands and areas with particularly difficult socio-economic conditions, other drugs may be sold as prescribed by the Health Minister. The
c / Participating in drug distribution of insurance, medical programs or projects when satisfying the requirements and conditions of such insurance, programs or projects.
2. Retail establishments being medicine stands have the following responsibilities:
a / The responsibilities defined in Clause 2, Article 42 of this Law;
b / Not to sell medicine materials, except for pharmaceuticals.
Article 49.- The rights and responsibilities of retail establishments are commune medicine clinics canteens
1. Retail establishments being commune medical ward medicine cabinets shall have the following rights:
a / The rights specified at Points a, b, c and e, Clause 1, Article 42 of this Law;
b / Purchasing and retailing drugs on the list of essential drugs suitable to technical and professional lines; In case of purchase and sale of drugs on the list of drugs subject to special control and the list of medicines restricted from retailing, the provisions of Article 34 of this Law shall apply.
c / Participating in drug distribution of insurance, medical programs or projects when satisfying the requirements and conditions of such insurance, programs or projects.
2. Retail establishments being commune medical ward medicine cabinets shall have the following responsibilities:
a / The responsibilities defined in Clause 2, Article 42 of this Law;
b / Not to sell medicine materials, except for pharmaceuticals.
Article 50.- Rights and responsibilities of establishments specialized in retailing pharmaceutical materials, materia medica and traditional medicines
1. Establishments specializing in retailing pharmaceutical materials, materia medica and traditional medicines shall have the following rights:
a / The rights specified at Points a, b, c and e, Clause 1, Article 42 of this Law;
b / Retailing pharmaceutical materials, materia medica, traditional medicines;
c / Purchasing pharmaceutical materials, materia medica and traditional medicines for retail sale;
d / To participate in the issuance of medicines of insurance, medical programs or projects when meeting the requirements and conditions of such insurance, programs or projects.
2. Establishments specializing in retailing pharmaceutical materials, materia medica and traditional medicines shall have the following responsibilities:
a / The responsibilities defined in Clause 2, Article 42 of this Law;
b / Not to sell pharmaco-chemical drugs, vaccines, biologicals and drug materials being medicaments, excipients or capsules.
Article 51.- Rights and responsibilities of establishments providing drug testing services and drug materials
1. Establishments providing drug testing services and drug materials shall have the following rights:
a / The rights specified at Points a and b, Clause 1, Article 42 of this Law;
b / To conduct the testing of drugs and raw materials for drug production according to regulations;
c / To certify the test results of tested drugs and drug materials;
d / Import and purchase of chemicals, standard substances, medicine samples and samples of raw materials for drug manufacture in service of drug establishments’ testing of drugs and raw materials for drug production.
2. Establishments providing drug testing services and drug materials shall have the following responsibilities:
a / The responsibilities prescribed at Points a, b, d, e, f, g, h, i, m and n, Clause 2, Article 42 of this Law;
b) To ensure truthfulness and objectivity in the testing of drugs and raw materials for drug manufacture;
c / To bear responsibility for the test results of drug samples and samples of tested drugs.
Article 52.- Rights and responsibilities of clinics providing clinical trial services
1. Clinical drug testing service establishments have the following rights:
a / The rights specified at Points a and b, Clause 1, Article 42 of this Law;
b / To conduct clinical trial activities according to regulations;
c) Importing and purchasing chemicals, standard substances and samples in service of clinical trial activities;
d / Using clinical trial drug results according to agreements with agencies, organizations and individuals that have clinical trial drugs.
2. Clinical trial drug service establishments have the following responsibilities:
a / The responsibilities prescribed at Points a, b, c, d, e, g, h, i, m and n, Clause 2, Article 42 of this Law;
b) To bear responsibility for the clinical trial results;
c / To take responsibility for the safety of the participants in the clinical trial and compensate for the damage caused to the participants in the clinical trial if the fault occurs due to the fault of the service establishment conducting clinical trial services. screened in accordance with the law;
d / To ensure truthfulness and objectivity in the clinical trial;
e / Being economically independent, organizing personnel for agencies, organizations and individuals that have clinical drugs.
Article 53.- Rights and responsibilities of establishments providing biological equivalent testing services for drugs
1. Establishments providing bioequivalence-testing services of drugs shall have the following rights:
a / The rights specified at Points a and b, Clause 1, Article 42 of this Law;
b) Carry out the clinical and biochemical phase of the bioequivalence assay of the drug.
If only the phase of biological analysis is carried out, it may be contracted or linked to a clinical trial drugstore that meets the Good Clinical Trial Practice to perform the clinical trial phase in the trial. the biological equivalent of the drug;
c) Conducting biological research and testing activities according to regulations;
d) Importing and purchasing chemicals, standard substances and samples in service of biological bioequivalence testing activities;
e / Using results of bioequivalence study and trial of drugs according to agreements with agencies, organizations and individuals having bioequivalent reagents.
2. Establishments providing bioequivalence-testing services for drugs shall have the following responsibilities:
a / The responsibilities prescribed at Points a, b, c, d, e, g, h, i, m and n, Clause 2, Article 42 of this Law;
b) To take responsibility for the results of the bioequivalence study of the drug on the samples already tested;
c) To take responsibility for the safety of participants in bioequivalence tests and compensate for damage caused to participants in bioequivalence tests if the risks occur due to the fault of the equivalent service-providing establishment. study of drugs according to the provisions of law;
d / To ensure truthfulness and objectivity in bioequivalence tests of drugs;
e / Economic independence, personnel organization for agencies, organizations and individuals having bioequivalent reagents.
Chapter V
REGISTRATION, DISTRIBUTION AND RECOVERY OF MEDICINES AND MEDICINAL MATERIALS
SECTION 1. REGISTRATION OF MEDICINES AND MEDICINAL MATERIALS
Article 54.- Subjects and requirements for registration of drugs and raw materials for drug manufacture
1. Drugs must be registered before their circulation in Vietnam, except for the following cases:
a / Drugs prepared according to prescriptions at drug stores specified at Point b, Clause 1 of Article 47; medicines produced or prepared at medical examination and treatment establishments defined in Article 85 of this Law;
b) Imported drugs specified in Clause 2, Article 60 of this Law;
c) Traditional medicines as prescribed in Clauses 1 and 2, Article 70 of this Law.
2. Medicine materials must be registered before being circulated in Vietnam, except for the following cases:
a / Medicine raw materials being medicines for production of medicines according to dossiers of registration of drugs already registered for circulation in Vietnam;
b / Medicinal materials are imported according to the provisions of Clause 3, Article 60 of this Law.
3. Establishments may register their names of medicines and drug materials in the following cases:
a) Establishments engaged in activities of producing, wholesaling, exporting and / or importing drugs and materials for drug manufacture in Vietnam;
b / Establishments trading in drugs and raw materials for drug manufacture of foreign countries having their representative offices in Vietnam.
4. Drugs and drug materials shall be granted registration papers for circulation in Vietnam when satisfying the following requirements:
a / Ensuring the requirements on safety and efficiency;
b / They are manufactured at establishments producing medicines and raw materials for medicine, which satisfy the conditions prescribed in this Law;
c) To be manufactured according to the process of producing drugs and raw materials for medicine production and meeting the quality standards prescribed in Article 102 and Article 103 of this Law.
5. For medicines and raw materials for imported medicines when they are registered for circulation in Vietnam, establishments producing medicines and medicine materials in foreign countries must be evaluated for satisfaction of Good Manufacturing Practice by one of the following: the following form:
a / Evaluating dossiers related to production conditions;
b / Recognition and mutual recognition of results of inspection and examination by the State management agency in charge of pharmacy, for requirements of satisfaction of good manufacturing practices of production of medicines and medicine materials;
c / Inspection at establishments producing drugs and raw materials for drug manufacture.
6. The Government shall specify the circulation registration of pharmaceutical materials, excipients, capsules and Clause 5 of this Article.
Article 55.- Forms of registration of drugs and raw materials for drug manufacture
1. Drugs and drug materials shall be registered in one of the following forms:
a / To issue circulation registration papers for drugs and raw materials for drug manufacture;
b / Renewal of circulation registration papers for drugs and raw materials for drug manufacture;
c / To change and supplement the registration papers for circulation of drugs and raw materials for drug manufacture.
2. To issue circulation registration papers for drugs and raw materials for drug manufacture in the following cases:
a / Drugs and raw materials for drug manufacture, which have not yet been granted circulation registration papers in Vietnam;
b / Medicines already granted circulation registration certificates, with changes in the composition of pharmaceuticals and materia medica; The content, concentration or volume of pharmaceutical ingredients and pharmaceuticals are effective; dosage forms; route of use; except in case of change of the secondary packaging establishment, ex factory, and place of manufacture;
c / Medicine raw materials already granted circulation registration certificates, with changes in production establishments, except for cases of change of secondary packing establishments, ex factory or factory locations.
3. Changes in or addition to certificates of circulation of medicines and drug materials granted in Vietnam shall be subject to changes in the validity duration, except for the cases specified at Points b and c, Clause 2 of this Article.
4. Extension of registration papers for circulation of drugs and raw materials for drug manufacture when the circulation registration papers expire, including drugs and raw materials for making drugs, with changes in administrative dossiers at the time of extension registration. .
Article 56.- Competence, dossiers, procedures and time limit for the grant, extension, change or supplementation of circulation registration papers for drugs and raw materials for drug manufacture
1. The Minister of Health shall grant, extend, change or supplement registration papers for circulation of drugs and raw materials for drug production on the basis of dossier examination and consultation by the Advisory Council for Registration of Circulation of Drugs. , raw materials for medicine.
Dossiers of application for grant, extension, change or supplementation of circulation registration papers for drugs and raw materials for drug manufacture shall be submitted to the Ministry of Health.
2. A dossier of application for a certificate of circulation of drugs and raw materials for drug manufacture comprises:
a / Administrative dossier comprises an application for a certificate of registration of circulation of drugs and raw materials for drug manufacture; Authenticated copy of License for establishment of a Representative Office with expiry date of validity for a foreign drug or drug substance trading establishment or certificate of eligibility for trading of a pharmaceutical product with a valid term for Establishments trading in medicines and medicinal materials of Vietnam; The original or certified copy of the pharmaceutical product certificate for the import drug still in the valid period; sample labels of drugs and raw materials for drug production; information on drugs and other documents on trading and circulation of drugs and raw materials for drug production;
b / Technical dossiers proving that drugs and drug materials meet the requirements specified in Clause 4, Article 54 of this Law; For new drugs, reference biologicals, vaccines and materia medica drugs prescribed for diseases on the list promulgated by the Health Minister, there must also be additional clinical dossiers proving their safety and effectiveness; For similar biologicals, there must be more similar records of quality, safety and efficacy than a reference biological; For drugs requiring bioequivalence testing, there must be a report on the bioequivalence of the drug;
c / The actual drug samples of drugs and raw materials for drug circulation in the host countries or reference countries, for import drugs.
3. Dossiers of application for extension of circulation registration papers for drugs and raw materials for drug manufacture include:
a / An application for extension of the circulation registration certificate for drugs and raw materials for drug manufacture;
b / A valid copy of the representative office establishment permit, for foreign-based medicine and medicine business establishments or certificates of full satisfaction of pharmaceutical trading conditions. For establishments trading in medicines and medicinal materials of Vietnam;
c / An original or valid copy of the valid pharmaceutical product certificate for import drugs;
d / Report on circulation of drugs and raw materials for drug production;
e / Report on the safety and effectiveness of drugs with requirements for continued safe and effective monitoring;
e / A copy of the circulation registration paper for medicine and medicine materials in Vietnam.
4. Dossiers of application for changes or supplements to registration papers for circulation of drugs and raw materials for drug manufacture include:
a / An application for change or supplementation of registration papers for circulation of drugs and raw materials for drug manufacture;
b / The technical dossier for the contents of change or supplementation of registration papers for circulation of drugs and raw materials for drug manufacture;
c / A copy of the valid registration certificate of circulation of drugs and raw materials for drug manufacture in Vietnam.
5. Time limit for the grant, extension or change of registration papers for circulation of drugs and raw materials for drug manufacture:
a / Within 12 months after receiving complete dossiers for the grant of circulation registration papers for medicine or raw materials for drug manufacture or from the date of receipt of complete dossiers for new drugs, reference bio-products or similar biological products , vaccines and / or medicinal herbs prescribed for diseases on the list promulgated by the Health Minister, with clinical dossiers proving their safety and effectiveness;
b / Within 3 months after receiving complete dossiers for extension, change or supplementation of registration papers for circulation of drugs and raw materials for drug manufacture;
c / Cases of not granting, extending, changing or supplementing registration papers for circulation of drugs and / or raw materials thereof or failing to fully meet the conditions for the grant, extension, change or supplementation of circulation registration papers, Medicinal materials must be written in writing, clearly stating the reasons therefor.
6. The validity term of the registration papers for circulation of drugs and raw materials for drug production is 5 years from the date of issue or extension.
The validity term of drug circulation registration papers is 3 years from the date of issuance of drugs with requirements for continued safe and effective monitoring.
7. The Minister of Health shall specify the dossiers and procedures for the grant, extension, change and supplement of circulation registration papers for drugs and raw materials for drug manufacture.
Article 57.- Rights and responsibilities of establishments registering drugs and raw materials for drug manufacture
1. Establishments registering medicines and medicinal materials shall have the following rights:
a / To guide the registration of drugs and raw materials for drug manufacture; To know the status of processing of dossiers of registration of drugs, raw materials for drug manufacture and other information related to drugs and raw materials thereof after being granted the circulation registration papers;
b / To withdraw circulation registration papers of medicines and raw materials for drug production, which are registered by establishments.
2. Establishments registering medicines and medicinal materials shall have the following responsibilities:
a / To notify the management agency in cases where medicines and raw materials for drug manufacture already granted circulation registration certificates in Vietnam are withdrawn in any country in the world; stopping production, stopping supply or risk and shortage of drugs and raw materials; To change the registration of medicines and medicinal materials for the duration of the valid circulation registration papers;
b / To archive complete dossiers of registration of drugs and raw materials for drug manufacture and supply dossiers to competent management agencies when so requested;
c / To meet requirements on inspection and evaluation of production establishments at the request of competent management agencies.
Article 58.- Withdrawal of registration papers for circulation of drugs and raw materials for drug manufacture
1. Circulation registration certificates for drugs and raw materials for drug production shall be withdrawn in the following cases:
a) Drugs are recalled due to level 1 violations;
b / Within two months, 02 lots of drugs shall be subject to compulsory withdrawal due to violations of level 2 or 03 lots of drugs or more, which are in breach of quality;
c / Import drugs have their pharmaceutical product certificates withdrawn by competent agencies of foreign countries, which are the basis for the Ministry of Health to grant registration papers for circulation of medicines and medicine materials in Vietnam;
d / Circulation registration papers for medicines and raw materials for production of drugs based on fake dossiers;
e) Medicaments and raw materials for production thereof are not produced at the right addresses according to the registration dossiers;
e) Medicaments, materia medica or drugs containing pharmaceutical substances or pharmaceuticals which are not safe and effective for use by the World Health Organization, the competent management agencies of Vietnam or the countries of origin. use;
g) Production establishments or establishments registering medicines and / or raw materials for drug manufacture shall propose withdrawal of registration papers for circulation of medicines and medicine materials in Vietnam.
2. The Minister of Health shall issue detailed regulations on dossiers and procedures for withdrawal of registration papers for circulation of drugs and raw materials for drug manufacture.
SECTION 2. CIRCULATION OF MEDICINES AND MEDICINAL MATERIALS
Article 59.- Provisions on circulation of drugs and raw materials for drug manufacture
1. Medicines and medicinal materials circulated on the market include:
a / Drugs and drug materials already granted circulation registration certificates;
b) Imported drugs and raw materials for medicine as prescribed in Clauses 1, 2, 3 and 4, Article 60 of this Law;
c / Drugs prescribed at Point b, Clause 1 of Article 47, Clauses 1 and 2 of Article 70 and Clause 3, Article 85 of this Law;
d / Drugs and materials used in the manufacture of domestically manufactured medicines may continue to be used up to the expiry date for use in cases where they are manufactured before the valid date of circulation registration papers;
e) Drugs and raw materials for import drug production may continue to be used up to the expiry date if they are delivered at the port of departure of the exporting country before the expiry date of the circulation registration certificate;
e) Drugs and raw materials for domestically manufactured medicines or medicines imported before the date of circulation registration papers are withdrawn under the provisions of Article 58 of this Law, except for cases where drugs and raw materials for drug production are withdrawn according to regulations Article 62 of this Law.
2. Drugs circulated on the market must meet the following requirements:
a / Satisfying quality standards and ensuring safety and efficiency;
b / Satisfying the drug labeling requirements prescribed in Article 61 of this Law and other relevant law provisions;
c / Packaging materials and packagings must meet the requirements of drug quality assurance.
3. Medicine materials for circulation on the market must meet the following requirements:
a / Satisfying quality standards for drug manufacture and ensuring safety and efficiency;
b / Satisfying the drug labeling requirements prescribed in Article 61 of this Law and other relevant law provisions;
c / Packaging materials and packagings must meet the quality assurance requirements of drug materials.
Article 60.- Medicine and medicine materials may be imported or exported
1. Drugs and raw materials for drug manufacture are those already registered for circulation in Vietnam, and raw materials for manufacture of drugs are drugs for production of medicines according to drug registration dossiers already registered for circulation of medicines in Vietnam. They are imported without having to carry out the import licensing, except for medicines and raw materials for medicine as prescribed in Clause 4 of this Article.
2. Drugs without circulation registration papers for circulation in Vietnam shall be granted import permits and may be imported not more than the quantity inscribed in their import permits in the following cases:
a / Containing pharmaceutical substances without circulation registration papers or already having circulation registration papers for drugs but drugs have not yet met the treatment demands;
b / Containing first-time medicines for use as drugs in Vietnam or having been used as medicines in Vietnam but drugs have not yet met the treatment demands;
c / To meet urgent needs for national defense, security, epidemic prevention and combat, overcoming the consequences of natural disasters, catastrophes and special treatment demands;
d) Rare drugs;
e / Medicines of the same commercial name, active ingredient content or content or concentration, dosage forms with original medicines having circulation registration certificates in Vietnam, manufactured by original manufacturers themselves or by authorized manufacturers, is priced lower than the original brand name medicinal product circulated in Vietnam at the request of the Minister of Health;
e) To serve the State’s medical programs;
g) Aid and humanitarian aid;
h) Clinical trials, bioequivalence tests, bioavailability assessments, registration samples, test samples, scientific research, exhibitions at exhibitions and fairs;
i) Other cases not for commercial purposes.
3. Raw materials for drug manufacture are those which have not yet been granted circulation registration certificates in Vietnam and are allowed to be imported only and can not be imported in excess of the quantity inscribed in their import permits in the following cases:
a / To make registration samples, drug testing samples and studies, exhibiting at exhibitions and fairs;
b / For the production of export drugs and drugs in service of national defense, security, epidemic prevention and combat, and overcoming the consequences of natural calamities and / or disasters.
4. Drugs subject to special control must be licensed for export or import, and may be exported or imported only in excess of the quantity inscribed in the permits.
Depending on each period of socio-economic development, the Government shall prescribe drugs and raw materials for drug production to control import.
5. Drugs and drug materials permitted for export without permits of the Ministry of Health, except for those on the list of species and types of precious and rare and endemic pharmaceuticals subject to control, drugs subject to special control, Medicinal materials are psychotropic substances, addictive drugs and pre-substances for use as drugs promulgated by the Minister of Health or radioactive substances on the list promulgated by the Government.
6. The Ministry of Health shall have to disclose information related to drugs subject to import licensing according to the provisions of Points a, b, c and d, Clause 2 of this Article, including importers, manufacturers, , drug name and import license number; The quantity of drug circulation registration certificates for each active substance.
7. The Government shall stipulate in details the following contents:
a / Criteria, dossiers, procedures and time limits for the import and export of drugs specified in Clauses 2, 3, 4 and 5 of this Article and the list of drugs and materials for manufacture of medicines banned from import, ban on production;
b / Import of pharmaceutical materials, excipients, capsules and packages in direct contact with medicines.
Article 61.- Labels of medicines and medicinal materials circulated on the market
1. Labels of medicines and medicinal materials circulated on the market must show the following contents:
a / Name of medicine, raw materials for drug production;
b) Dosage form, excluding medicinal materials;
c / Composition, content, concentration or volume of pharmaceutical substances and / or pharmaceuticals of drugs and raw materials for drug manufacture; The labels of traditional medicines on the list of State secrets and traditional herbal medicines are not allowed to show a number of components of materia medica, content and volume of materia medica and must be inscribed with ” state secret “or” formulation of the drug is a traditional secret “;
d / Packing specifications;
e / The name and address of the production establishment;
e) The name and address of the importing establishment for imported medicines and raw materials;
g) Number of circulation registration certificate or import permit number, production lot number, production date;
h) The expiry date of the drug or drug substance;
i) Preservation conditions and other necessary information as prescribed.
2. Drug use leaflets are an inseparable part of a medicine label and contain all the information specified at Points a, b, c, d, e, h and i of Clause 1 of this Article and are displayed. in Vietnamese, unless the information can not be translated into Vietnamese or translated into Vietnamese without meaning.
3. The Minister of Health shall detail the labeling of medicines, raw materials for manufacture of medicines and use instructions; To decide on the change of shelf life of medicines already inscribed on drug labels in cases where they are due to national defense or security or epidemics prevention and combat or the consequences of natural disasters or catastrophes.
SECTION 3. RECOVERY OF MEDICINES AND MEDICINAL MATERIALS
Article 62.- Cases of recall of drugs and raw materials for drug manufacture
1. Drugs shall be withdrawn in the following cases:
a / Not being in the cases permitted for circulation prescribed in Clause 1, Article 59 of this Law;
b / Circulation circulation registration papers for withdrawn drugs in the cases specified at Points a, b, d, e and f, Clause 1, Article 58 of this Law;
c / Failure to meet the requirements specified in Clause 4, Article 54 or Clause 2, Article 59 of this Law;
d / Drugs not up to the quality standards, drugs manufactured from raw materials for production of drugs which fail to meet quality standards;
e / Having conclusions of competent state agencies on drugs failing to meet safety and efficiency requirements;
e) Drugs without proof of quality inspection during production and before delivery;
g) There is a notice of drug withdrawal issued by the foreign pharmaceutical management agency.
2. Medicaments for circulation on the market shall be withdrawn in the following cases:
a / Raw materials for making drugs for use for wrong purposes;
b / Circulation of circulation of medicated drug materials in cases specified at Points d, e and f, Clause 1, Article 58 of this Law;
c / Failure to meet the requirements specified in Clause 4, Article 54 or Clause 3, Article 59 of this Law;
d / Raw materials for drug manufacture failing to meet quality standards for drug manufacture; Raw materials for improper use of medicines already registered for circulation or import permits;
e / Raw materials for production of drugs without evidence, which have been inspected in the course of production and before their release;
e / There is a notice on withdrawal of medicinal materials of the foreign pharmaceutical management agency.
Article 63.- Forms of recovery, extent of violations, scope and time of recovery and disposal of recovered drugs
1. Forms of drug recovery include:
a / Voluntary recall is the withdrawal by drug registration establishments, production establishments or establishments that import or consign the import of voluntary drugs;
b / For compulsory withdrawal, it is withdrawn according to the decision of the competent State agency in case of withdrawal prescribed in Article 62 of this Law.
2. Violation levels of drugs include:
a) Level 1 is the extent to which the drug is likely to cause serious harm to the health or life of the user;
b / Level 2 is the extent to which evidence-based medications fail to adequately treat the therapeutic effect or threaten the user’s safety, but not seriously enough to cause serious health damage or harm. to the lives of users;
c / Level 3 means a level not falling into the cases prescribed at Points a and b of this Clause but due to other causes but does not affect the therapeutic effect and safety when used.
3. The scope and time limit for drug recalls shall be as follows:
a) Withdrawal at all pharmacy business establishments, medical examination and treatment establishments and users in case of violation drugs at level 1. The recovery must be completed within 3 days after the date of obtaining withdrawal decision;
b) Withdrawal at all pharmacy business establishments, medical examination and treatment establishments and users in the case of violation drugs at level 2. Recovery must be completed within 15 days from the date of receipt. withdrawal decision;
c) To be withdrawn at all drug-dealing establishments in the case of violation drugs at level 3. Recovery must be completed within 30 days after the recovery decision is issued;
d) In cases where the recapture of level-1 drugs and the recall of drugs beyond the recovery capacity of domestic drug-manufacturing establishments, importing establishments or establishments entrusting the import of drugs or overdue If the domestic drug-manufacturing establishment, the importing establishment or the import-entrusting drug-importing organization fails to recover it, it shall be compelled to recover it according to the provisions of law.
The competent state agencies shall organize the compulsory recall of drugs; Domestic drug-manufacturing establishments, importing establishments and drug-importing entrusted establishments shall have to pay expenses for the recovery and disposal of recovered drugs.
4. Handling of recovered drugs shall be effected as follows:
a / Drugs withdrawn under the provisions of Points a and b, Clause 2 of this Article must be destroyed;
b / Drugs to be withdrawn according to the provisions at Point c, Clause 2 of this Article may be remedied, re-exported or destroyed if they can not be remedied.
Article 64.- Responsibility to recover drugs
1. Drug registration establishments, domestic drug-manufacturing establishments, establishments producing, processing and producing drugs, importing establishments or establishments entrusting the import of drugs subject to recovered drugs shall have the following responsibilities: The following:
a / Stopping the drug business;
b / To assume the prime responsibility for, and coordinate with concerned organizations and individuals in, announcing information on withdrawn drugs and organizing the withdrawal and receipt of recovered drugs;
c) Dealing with withdrawn drugs;
d / Payment of expenses for the recovery and disposal of recovered drugs and compensation for damage according to the provisions of law;
e / To report to the Health Ministry on drug withdrawal and drug withdrawal results;
e) In case of voluntary withdrawal, the suspended drug business must be suspended and reported to the Ministry of Health before proceeding with drug withdrawal.
2. Drug wholesale and retail establishments have the following responsibilities:
a / To stop trading and distribute recovered drugs;
b / To notify and organize the recovery and receipt of recovered drugs handed back by business establishments, users and users;
c / To return medicine to the establishment supplying the drug;
d / Payment of expenses for the recovery and disposal of recovered drugs and compensation for damage according to the provisions of law in case of errors.
3. The medical examination and treatment establishments and the drug users shall have the following responsibilities:
a / To stop prescribing, selling, distributing and using recovered drugs;
b / To return recovered drugs to drug-supplying establishments.
4. The Ministry of Health has the following responsibilities:
a / Basing themselves on the seriousness of their violations in terms of quality, safety and efficiency, to decide on the withdrawal and treatment of recovered drugs nationwide;
b / Reviewing evaluation reports and replies on voluntary proposals withdrawn from production or business establishments;
c / To inspect and supervise the organization and recovery of drugs and raw materials for drug manufacture; To handle violations according to the provisions of law;
d / To announce information on the withdrawn drugs on the portal of the Ministry of Health, Vietnam Television and the Voice of Vietnam for the case of withdrawal of violating drugs at level 1 right after their availability. Decision to withdraw drugs.
5. Vietnam Television and the Voice of Vietnam shall have to disclose information on level-1 violation remission and charge-free.
Article 65.- Competence to issue decisions on drug withdrawal and drug withdrawal procedures
1. The Ministry of Health shall issue decisions to withdraw drugs in case of compulsory withdrawal and cases of voluntary withdrawal when violation drugs are at level 1 and level 2. The time limit for issuance of drug withdrawal decisions shall not exceed Twenty-four hours after the conclusion is reached, the drug must be withdrawn and the violation level of the drug or the conclusion on the withdrawal of the voluntary drug is inappropriate to the extent of violation of the drug.
2. Heads of medicine-registering establishments, domestic drug-manufacturing establishments, drug formulation, processing or -creating establishments or establishments importing or authorizing the import of drugs shall issue drug withdrawal decisions. Voluntary recall of drugs in violation level 3 after consultation with the Ministry of Health. The time limit for issuance of drug withdrawal decisions shall not exceed 24 hours from the date of receipt of comments from the Ministry of Health.
3. The Minister of Health shall issue detailed regulations on the conclusion of drugs subject to withdrawal, the extent of drug violations, the procedures for drug withdrawal and the treatment of recovered drugs.
4. The Government shall prescribe the competence, form and procedures for recovery of medicinal materials; Measures to treat drug materials are withdrawn.
CHAPTER VI
MATERIALS AND TRADITIONAL MEDICINE
ITEM 1. MATERIALS
Article 66. Cultivation, collection, extraction and processing of materia medica
1. The cultivation and collection of medicinal herbs in compliance with good practice of aquaculture and collection of medicinal herbs.
2. The exploitation and processing of natural medicinal herbs must ensure the correct types, specifications, process, time and methods of processing and preservation of each medicinal herbs.
3. The Minister of Health shall issue a roadmap for the application of good practice on aquaculture and collection of materia medica and promulgate the principles and criteria for exploitation of natural materia medica suitable to the socio-economic development conditions. .
Article 67.- Preservation of materia medica
1. The preservation of materia medica must comply with the good practice on preservation of drugs and raw materials for drug manufacture.
2. Medicinal substances circulating on the market must be packed in standard packing and labeled in accordance with the regulations of the Minister of Health.
Article 68.- Quality of medicinal herbs
1. Medicinal materials must meet quality standards, with clear origins and origins. When putting into production, processing and preparation of medicines, the level of chemical residues of plant protection chemicals, preservatives, limits of heavy metals, microbiological limits, toxic limits of medicinal substances must not exceed specified level.
2. Organizations and individuals producing, importing, processing and supplying pharmaceutical materials shall have to publicize the standards of materia medica according to the provisions of law on standards and technical regulations in cases where pharmaceutical materials have not yet been published. sign for circulation and bear responsibility for the source and quality of medicinal herbs; To report to the State management agency in charge of pharmaceuticals on the quantity of medicinal herbs to be imported for trading and used for preparation, processing and manufacture of drugs.
3. The Minister of Health shall detail this Article.
Section 2. TRADITIONAL MEDICINE
Article 69.- Trading in traditional medicines
1. The trading of traditional medicines shall comply with the provisions in Chapter IV of this Law.
2. Establishments producing traditional medicines for circulation nationwide or traditional medicine retailing establishments must satisfy the following conditions:
a / Traditional medicine production establishments must have locations, production workshops, testing laboratories, drug preservation warehouses, drug materials, auxiliary systems, preservation of drugs, quality management systems, technical and professional documents and compliance with Good Manufacturing Practices for traditional medicines;
b / Establishments specializing in retailing pharmaceutical materials, materia medica and traditional medicines must abide by the regulations on preservation locations, areas, preservation equipment, technical and personnel documents;
c / Persons responsible for pharmacy expertise or persons in charge of medicine quality at traditional medicine-producing establishments must possess professional diplomas specified at Point a or c, Clause 1, Article 13 of this Law, and 02 Professional practice at a pharmaceutical establishment in accordance with the practitioner’s professional practice, except for cases specified at Point d of this Clause. Persons responsible for pharmacy expertise of traditional medicine-manufacturing establishments which are nationwide may also be in charge of quality assurance of medicines of production establishments;
d / Persons responsible for pharmacy expertise, persons in charge of drug quality assurance of cooperatives or traditional medicine business households must have one of the professional diplomas specified at Points a, c, e, g, i or l, Clause 1, Article 13 of this Law, and have 2 years of professional practice at pharmacies suitable to practitioners’ professional qualifications, except for cases specified at Point c, Clause 2, Article 13 of the Law. This. Persons responsible for pharmacy expertise of cooperatives or traditional medicine business households may concurrently be in charge of quality assurance of medicines of production establishments;
e / Persons responsible for pharmacy expertise of traditional medicine retailing establishments shall comply with the provisions of Clause 4, Article 18 of this Law.
3. The Government shall stipulate in detail the trading in traditional medicines and the management of traditional medicines imported into Vietnam.
Article 70.- Supply, processing, preparation and use of traditional medicines in medical examination and treatment establishments
1. Traditional medicine examination and treatment establishments are allowed to process, prepare and scale traditional medicines according to prescriptions and prescriptions for use and retail according to their applications at such establishments.
2. Traditional medicines given by hospitals to traditional medicine or medical treatment at provincial or higher levels for processing and preparation may be sold to medical examination and treatment establishments that conduct medical examination and treatment activities. Other traditional medicine in the same province or city under central authority to treat patients at that facility.
3. Heads of medical examination and treatment establishments which process or manufacture traditional medicines must take responsibility for the quality, safety and efficiency of medicines supplied by their own processing and preparation establishments.
4. The Minister of Health shall prescribe the conditions for processing, preparation and management of traditional medicines prescribed in this Article.
Article 71.- Registration, circulation and withdrawal of traditional medicines
1. Traditional medicines circulated on the market must register, circulate and withdraw drugs according to the provisions in Chapter V of this Law, except for the provisions in Clause 2 of this Article.
2. The time limit for granting, extending, changing or supplementing registration paper for circulation of traditional medicines is provided for as follows:
a / Within 6 months after receiving complete dossiers for the granting of registration papers for circulation of traditional medicines;
b / Within 12 months after receiving complete dossiers for the granting of registration papers for circulation of traditional medicines for traditional medicines subject to clinical trial;
c / Within 01 month from the date of receipt of complete dossiers for extension, change or supplementation of registration papers for circulation of traditional medicines;
d / In case of not granting, extending, changing or supplementing traditional medicine circulation registration papers or failing to fully meet the conditions for granting traditional medicine circulation registration papers under the provisions of this Law, clearly stating the reason.
3. Traditional medicines shall be weighed in accordance with prescriptions and prescriptions processed or prepared at medical examination and treatment establishments according to the provisions of Clauses 1 and 2, Article 70 of this Law, which must not be registered for circulation. . The heads of the establishments shall have to recover medicines according to regulations when detecting that the drugs are not up to quality, safety and efficiency
Article 72.- Traditional clinical drug trials before circulation registration
1. Traditional medicines shall be exempt from trial, exempt from some clinical trials or fully tested in stages.
2. Traditional medicines shall be exempt from clinical trial in the following cases:
a / Traditional medicines already recognized by the Ministry of Health;
b / Traditional medicines already granted circulation registration certificates before the effective date of this Law, except for those subject to clinical trial application granted by the Advisory Council for Registration of Circulation of Drugs and Drug Materials.
3. The Minister of Health shall prescribe specific criteria to determine cases of exemption from some traditional clinical trial or clinical trials in full stages in Vietnam.
Article 73.- Quality of traditional medicines
1. Traditional medicines shall be weighed in accordance with prescriptions, prescriptions, prepared and processed in medical examination and treatment establishments defined in Clauses 1 and 2, Article 70 of this Law, so quality must be ensured. Ministry of Health regulations.
2. Traditional medicines circulated nationwide must ensure the quality prescribed in Articles 102 and 103 of this Law.
3. The Minister of Health shall stipulate the recognition of traditional and traditional medicines; prescriptions, prescriptions used for weighing (unloading); instruction on methods of processing, preparing or submitting to the theory and method of traditional medicine; Guidelines for traditional medicines in the form of modern dosage forms.
Chapter VII
PRESCRIPTION DRUGS AND USE
Article 74.- Prescriptions of drugs
1. Drug prescriptions are grounds for selling drugs, distributing drugs, preparing medicines, weighing and dispensing drugs, using drugs and guiding the use of drugs.
2. The Minister of Health shall stipulate in detail the prescriptions and the prescription of medicines.
Article 75.- Use of drugs
1. The use of drugs in medical examination and treatment establishments shall comply with the provisions of law on medical examination and treatment.
2. Use of drugs outside medical examination and treatment establishments is stipulated as follows:
a / Drug users have the right to select drug-retailing establishments to buy drugs; To comply with the guidance stated in the prescriptions, the drug use instructions and drug use instructions of drug retailers;
b) Drug prescribers shall guide the use of drugs prescribed in the prescriptions and bear responsibility for prescribed prescriptions;
c / Drug-retailing establishments must guide the use of drugs for users.
3. The Minister of Health shall stipulate the establishment of an inter-branch Council defining the causes and the persons responsible for the cases where the drugs seriously affect the health and life of the users.
Chapter VIII
MEDICINES, PHARMACEUTICALS AND ADVERTISING MEDICINE
Article 76.- Contents and responsibilities of drug information
1. Drug information for the purpose of guiding the rational, safe and efficient use of drugs for medical examination and treatment practitioners and drug users.
2. Drug information must be up-to-date, clear, complete and accurate, based on evidence, easy to understand, suitable to the subject of the information.
3. Bases for elaboration of drug information contents include the following documents, except for the cases specified at Point c, Clause 5, and Point a, Clause 6 of this Article:
a) Vietnam National Drug Administration;
b / Drug use instructions already approved by the Ministry of Health;
c / Drug-related professional documents and guidance promulgated or recognized by the Ministry of Health.
4. Vietnamese National Pharmacopoeia is an official document on guidelines for rational, safe and effective use of drugs. The Minister of Health is responsible for issuing and updating the National Pharmacopoeia of Vietnam.
5. Drug information contents include:
a / Information on medical examination and treatment practitioners, including drug names, composition, concentration, content, dosage forms, indications, contraindications, dosages, use and use of drugs on special information, information relating to warning and safety of drugs and other necessary information;
b) Information for drug users includes drug names, utility, indications, contraindications, dosages, use and matters to be noted in the course of drug use;
c) Information to the State management agency in charge of pharmacy, including updated information on drug quality, safety and efficiency.
6. Responsibility to provide drug information is provided for as follows:
a / Pharmaceutical traders and representative offices of foreign traders operating in the pharmaceutical domain in Vietnam and drug registration establishments shall update their drug information on the market for State administrative body for pharmacy;
b / Pharmacy business establishments and representative offices of foreign traders operating in the pharmaceutical domain in Vietnam and medicine-registering establishments shall supply drug information in conformity with the information prescribed in Clause 3 This is for practitioners of medical examination and treatment and drug users.
Persons of drug dealing establishments shall introduce drugs to medical examination and treatment practitioners according to the regulations of the Health Minister;
c / Medical examination and treatment practitioners shall supply relevant drug information to drug users in the course of medical examination and treatment;
d / Pharmaceutical pharmaceutical state management agencies shall, within the ambit of their respective tasks and powers, have to publicize information on drug quality, safety and efficacy.
7. Drug information-providing organizations and individuals shall be responsible for the information they supply.
Article 77.- Pharmacovigilance
1. Contents of pharmacovigilance activities include:
a / To monitor, detect and report information on drug-related adverse reactions, drug-related errors, suspected counterfeit medicines, drugs not up to quality standards and information on non-prescription drugs. or ineffective treatment;
b) To collect and process information specified at Point a of this Clause; evaluation of benefits, risks, conclusions, management of risks related to drugs;
c) Announcing competent authorities’ conclusions on drug safety issues.
2. Drug users, when having irregular signs in the use process, shall have to notify such to the medical examination and treatment establishments or drug-retailing establishments where they have purchased medicines and medical examination and treatment establishments so that Take measures to handle in time.
3. Practitioners of medical examination and treatment shall have the following responsibilities:
a / To take initiative in monitoring and detecting signs of irregularities and errors related to drugs and doubting the quality and efficiency of drugs in the course of professional practice;
b) Evaluation, treatment and prevention when detecting signs of irregularities, errors or when receiving information from drug users defined in Clause 2 of this Article;
c / To report to the competent agencies on the information gathered when performing the responsibilities defined at Points a and b of this Clause.
4. Drug retailers have the following responsibilities:
a / Providing consultancy within the professional scope to drug users on measures to handle irregular signs in the course of drug use;
b / To collect and report to competent agencies information on irregular signs in the course of drug use.
5. Drug manufacture and preparation establishments, drug-manufacturing establishments and drug registration establishments have the following responsibilities:
a / Organizing the monitoring of the quality, safety and efficacy of drugs when being put into circulation on the market;
b / To report and update information to competent agencies on the quality, safety and efficiency related to drugs they manufacture, register for circulation, preparation and processing.
6. The Health Minister shall stipulate the temporary cessation of business, use and sealing of prescriptions in cases where drugs show unsafe signs to users.
Article 78.- Organizing drug information activities and pharmacovigilance
1. Pharmacy business establishments and medical examination and treatment establishments shall have to organize drug information activities and pharmacovigilance at establishments.
2. The Minister of Health shall have the responsibility to organize a system of drug information and pharmacovigilance.
3. The Government shall specify the competence, dossiers and procedures for receiving, evaluating and certifying the contents of drug information.
Article 79.- Advertisement of drugs
1. The advertisement of drugs shall comply with the advertising contents already certified by the Ministry of Health and according to the provisions of law on advertisement.
Within 15 days after receiving complete dossiers of application for certification of drug advertisement contents, the Ministry of Health shall evaluate and grant written certification of drug advertisement contents. In case of refusal to grant advertising contents certification or request for modification or supplementation of advertising contents, the Ministry of Health shall reply in writing, clearly stating the reasons therefor.
2. Conditions for advertised drugs are stipulated as follows:
a / Being on the list of drugs not prescribed;
b / It is not restricted to use or used under the supervision of a physician at the recommendation of a competent state agency;
c / The valid circulation registration certificate for medicine circulation in Vietnam.
3. The Government shall stipulate in detail drug advertising contents, dossiers and procedures for receiving, evaluating and certifying contents of drug advertising.
Chapter IX
CLINICAL PHARMACY
Article 80.- Contents of clinical pharmacy activities
1. To provide consultancy in the course of formulating lists of drugs at medical examination and treatment establishments in order to ensure rational, safe and effective use of drugs.
2. Advise and supervise the prescription and use of drugs.
Information and guidance on the use of drugs for medical examination and treatment practitioners, drug users and the community.
4. Participate in the development of professional procedures and guidelines related to drug use and monitor the implementation of these procedures.
5. Analyzing and evaluating the effectiveness of the use of drugs at medical examination and treatment establishments.
6. Participate in monitoring, monitoring the adverse reactions of drugs.
7. To participate in scientific research activities related to rational, safe and effective use of drugs.
Article 81.- Deployment of clinical pharmacy activities
1. The heads of medical examination and treatment establishments engaged in drug use activities shall have to organize and deploy clinical pharmacy activities according to the contents prescribed in Article 80 of this Law.
2. The person in charge of the specialized pharmacy shall have to carry out clinical pharmacy activities according to the provisions in Clauses 2, 3 and 6, Article 80 of this Law as follows:
a / Consultancy and supply of drug information to drug purchasers and users;
b / Consultancy and consultation with prescribers in case of detecting the unreasonable prescription of drugs;
c) To participate in monitoring and supervising the adverse reactions of drugs.
3. The Government shall stipulate the organization and operation of clinical pharmacy by medical examination and treatment establishments, including medical examination and treatment establishments of the people’s armed forces.
Article 82.- Rights and obligations of persons engaged in clinical pharmacy work
1. Clinicians working at medical examination and treatment establishments shall have the following rights and obligations:
a) Access to patients, medical records and prescriptions to advise the prescriber on the use of drugs;
b / To communicate with practitioners medical examination and treatment so that the prescription and use of drugs are reasonable, safe and effective.
c / To record professional opinions on clinical pharmacy in their medical records and prescriptions; To reflect opinions with the drug and treatment councils of the medical examination and treatment establishments or the heads of the medical examination and treatment establishments in cases where there are divergent opinions on prescribing or using drugs for the patients. The
d / Participating in professional conferences, medical examination papers, prescriptions;
e) To participate in the formulation of standard treatment guidelines; the list of drugs at medical examination and treatment establishments; technical processes related to medicine;
e) To participate in monitoring and supervising the adverse reactions of drugs;
g) To exercise other rights and obligations as prescribed by law.
2. Pharmacy pharmacy practitioners shall have the following rights and obligations:
a / Consultancy and supply of drug information to drug purchasers and users;
b / Consultancy and consultation with prescribers in case of detecting the unreasonable prescription of drugs;
c / Participating in monitoring and supervising the adverse reactions of drugs;
d / To exercise other rights and perform other obligations according to the provisions of law.
Article 83.- The State’s policies on clinical pharmacy activities
1. To invest in facilities, material, equipment and human resources suitable for clinical pharmacy activities at the State-run medical examination and treatment establishments; To prioritize the recruitment of pharmacists specialized in clinical pharmacy at the State medical examination and treatment establishments.
2. Investment in facilities, material, equipment and human resources for state-owned pharmacists of pharmacists; State budgets shall support tuition fees for clinical pharmacy specialists.
3. The State encourages organizations and individuals to participate in the training of pharmacists for clinical pharmacy work, investment in material foundations and equipment for clinical pharmacy activities.
Chapter X
MANAGEMENT OF MEDICINES IN MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS
Article 84.- Supply, preservation, distribution and use of drugs
1. The heads of medical examination and treatment establishments shall have to ensure the supply of adequate quality medicines in service of emergency or medical examination and treatment demands at medical examination and treatment establishments; Organizing the sale of drugs at night at district-level medical examination and treatment establishments or higher.
2. The preservation of drugs in medical examination and treatment establishments must comply with the provisions on good practice in drug preservation and other relevant law provisions.
3. The distribution of drugs in medical examination and treatment establishments must strictly comply with the orders or prescriptions, clearly stating the names of medicines and their contents on the medicine containers and give instructions to the users.
4. The use of radioactive drugs may be carried out only at medical examination and treatment establishments with nuclear medicine specialists and the Ministry of Science and Technology shall grant radiation work permits according to the provisions of Law on atomic energy.
5. The Health Minister shall prescribe the drug wastage rates and the payment of expenses for drug wastage at the medical examination and treatment establishments.
Article 85.- Production and preparation of medicines in medical examination and treatment establishments
1. The heads of medical examination and treatment establishments that produce and prepare medicines for use at medical examination and treatment establishments shall have to take responsibility for the quality and management of the medicines they produce. , preparation.
2. The medical examination and treatment establishments are allowed to produce and prepare to meet the treatment demands of the establishments when they fully meet the conditions prescribed by the Minister of Health.
3. Radiant medical examination and treatment establishments producing or dispersing radioactive drugs, apart from the provisions of Clauses 1 and 2 of this Article, shall have to apply security measures to ensure that they do not lose drugs. radioactive materials and licensed by the Ministry of Science and Technology to carry out radiation work in accordance with the law on atomic energy.
Drugs manufactured or prepared according to the provisions of this Clause shall be supplied to other medical examination and treatment establishments according to the regulations of the Minister of Health.
CHAPTER XI
CARDIOVASCULAR MEDICINES, BIOCHEMICALS OF MEDICINES
ITEM 1. CLINICAL DRUGS
Article 86. Clinical trial phases
Stage 1 is the first phase of human trials to assess the safety of the drug.
Phase 2 is the trial phase to determine the optimal dose for clinical trials and to demonstrate the safety and efficacy of the drug including the immunogenicity of the test vaccine on the target population.
Phase 3 is a large-scale trial to determine the stability of the formula, safety and efficacy at the overall level of the drug or to evaluate the protective effect and The safety of vaccines on the target population.
Stage 4 is a phase that is conducted after the drug has been circulated to further evaluate the safety and efficacy of the drug and to monitor the protective effect of the vaccine after it is widely used in the community in accordance with the conditions of use.
Article 87.- Clinical trials for drug circulation registration
1. Phase 1, 2 and 3 clinical trials are conducted prior to drug registration.
Stage 4 clinical drug trials shall be conducted after the drug circulation registration at the request of the competent pharmaceutical management agency.
Article 88.- Requirements for clinical drugs
1. Clinical reagents must satisfy the following requirements:
a) has been studied in pre-clinical stage;
b / Having stable forms of preparation;
c / Satisfying the quality standards according to the clinical trial registration dossiers.
2. Labels for clinical reagents must be inscribed with the phrase “Drugs for clinical trials. Prohibition for other purposes. ”
Article 89.- Drugs must be clinically tested, exempt from clinical trials or exempt from some clinical trials when registering for drug circulation
1. Drugs must fully test clinical stages in the following cases:
a / New drugs, except for cases specified at Point a, Clause 2, and Point b, Clause 3 of this Article;
b / Medicinal drugs with a new combination of medicinal herbs, which have been used as drugs in Vietnam, and have been prescribed for diseases on the list promulgated by the Health Minister, except for cases prescribed at Point b. Clause 2 and Point c, Clause 3 of this Article;
c / Vaccines for the first time registered for circulation in Vietnam, except for cases specified at Point c, Clause 2 of this Article.
2. Drugs are exempt from some clinical trials in the following cases:
a) New drugs have been licensed for circulation in at least one country in the world, but there is insufficient clinical data on safety and effectiveness;
b / Medicinal materials other than those specified at Point c, Clause 3 of this Article;
c) Vaccines are already licensed in at least one country in the world and have clinical and safety data available.
3. Drugs shall be exempt from clinical trial in the following cases:
a) generic drugs;
b) New drugs have been licensed for circulation in at least one country in the world and have adequate safety and efficacy data except for vaccines;
c / Medicinal herbs already granted a circulation registration certificate before the effective date of this Law, except for those prescribed for diseases on the list promulgated by the Minister of Health.
4. The Minister of Health shall stipulate in detail the requirements on clinical data to ensure safety and effectiveness and the criteria for determination of trial exemptions, exemption from some clinical trials in Vietnam and drugs must require Phase 4 clinical trials.
Article 90. Conditions of participants for clinical trial
1. Must be a volunteer who satisfies the professional requirements of the clinical trial and must sign a voluntary agreement to participate in the research with a clinical trial service establishment, except for the restricted person. Capacity for civil acts, civil capacity loss.
2. In cases where they have not yet reached the age of majority, their civil act capacity or civil act capacity is restricted, the consent of their representatives or guardians must be obtained according to the provisions of law.
3. In case of pregnant or lactating women, the research dossiers must clearly state the reasons for selection and appropriate measures to protect the participants in the clinical trial.
Article 91.- Rights and obligations of participants in clinical trial drug
1. Participants in clinical trial trials shall have the following rights:
a / Before testing, to be provided with complete and truthful information and possible risks;
b / Being liable to pay compensation for damage caused by drug testing by organizations and / or individuals that have clinical trial drugs;
c / To keep confidential all relevant personal information;
d) Not be responsible for unilaterally terminating the clinical trial participation;
e / To complain, initiate lawsuits or denunciations about law-breaking acts of organizations and individuals that have clinical drugs and receive drug-testing.
2. Participants in clinical trial trials are obliged to comply with the guidelines of the investigator in accordance with approved clinical trial documentation.
Article 92.- Rights and responsibilities of organizations and individuals having clinical drugs
1. Organizations and individuals that have clinical trial drugs have the following rights:
a / To select organizations which meet the requirements on material foundations and professional personnel for drug testing;
b) Possessing all research results of clinical reagents.
2. Organizations and individuals that have clinical drugs have the following responsibilities:
a / To pay compensations for damage caused to drug testers in clinical trials if risks arise from drug testing according to law provisions;
b / To sign contracts for clinical trial testing with drug-receiving establishments;
c) To take responsibility before law for the quality and safety of the medicines they supply.
Article 93.- Rights and responsibilities of clinical trial-receiving establishments
1. Clinical trials shall have the following rights:
a / Conducting clinical trial activities according to regulations;
b) Importing and purchasing chemicals, standard substances and samples in service of clinical trial activities;
c / Using clinical trial results as agreed upon with organizations and individuals that have clinical trial drugs.
2. The clinical trial-receiving establishments have the following responsibilities:
a) To bear responsibility for the clinical trial results;
b) To take responsibility for the safety of participants in the clinical trial and compensate for the damage caused to the participants in the clinical trial if there is a risk occurring due to the fault of the clinical trial-receiving unit. provisions of law;
c) To ensure truthfulness and objectivity in clinical trial medicine;
d / Being economically independent, organizing personnel for organizations and individuals that have clinical drugs.
Article 94.- Principles and competence for approval of clinical trial drugs
1. Clinical trial testing is only possible after a clinical and ethical review by the Ethics Council in a national biomedical research study for clinical trials and approved by the Minister. The Ministry of Health shall approve in writing.
2. Clinical trials, scientific and ethical evaluation of clinical trial dossiers and clinical trial approval shall be carried out according to the following basic principles:
a / To respect the right of self-determination of drug testers, to protect those whose rights to self-determination are restricted;
b) Ensure that the benefits of the study are greater than the risks and risks of the study being carefully considered and minimized in accordance with the standards;
c) Equality of benefits and responsibilities for each participant in the trial, ensuring that benefits and risks are equally distributed to participants;
d) Ensure clinical trials are in place and adherence to Good Clinical Practice Good Practice.
3. The ethics committee in biomedical research is an independent body established at the national and grassroots level to protect the rights, safety and health of participants in the trial.
The Minister of Health regulates the establishment and functions, duties and powers of the Ethics Council in biomedical research.
Article 95.- Files and procedures for clinical trial testing
1. Drug registration dossiers include:
a / A written request for clinical trial;
b) Records of product information;
c / The legal dossier of the research product;
d / The protocols for clinical trial and demonstration studies;
e / The scientific curriculum vitae of the researcher;
e) Information leaflet and volunteer participation card for study participants;
g) Minutes of scientific and ethical evaluation in ethics committee research in biomedical research at the grassroots level;
h) Research drug labels.
2. The clinical trial procedures are prescribed as follows:
a / To register for clinical trial drug research;
b / To approve clinical trial drug research;
c / To organize the clinical trial of drugs;
d / To approve the clinical trial results.
3. The Minister of Health shall detail this Article.
Section 2. BIOCHEMICAL TRACTIONS OF DRUGS
Article 96.- Bioequivalence testing periods of drugs and drugs subject to bioequivalence testing
1. Bioequivalence testing of drugs includes the following periods:
a) The stage of clinical research is the phase of testing of control drugs and bioequivalent reagents that meet the safety and efficacy requirements for comparing the bioavailability of the two drugs on the volunteers;
b) The human epidemiological analysis stage is the analysis phase, which determines the concentration of control drugs and bioequivalent reagents in the volunteer biopsy specimens after being used at the clinical stage of the study. To compare bioavailability and to demonstrate bioequivalence of the two drugs.
Generic drugs must be tested for bioequivalence when they have pharmaceutical substances or preparations on the list of those subject to the bioequivalence test issued by the Minister of Health.
Article 97.- Conditions, rights and obligations of participants in the bioequivalence test of drugs
1. Participants in bioequivalence tests of drugs must satisfy the conditions specified in Article 90 of this Law.
2. The rights and obligations of participants in the bioequivalence test of drugs shall comply with the provisions of Article 91 of this Law.
Article 98.- Rights and responsibilities of organizations and individuals having bioequivalent reagents
1. Organizations and individuals having bio-equivalent reagents shall have the following rights:
a / To select organizations which meet the requirements on material foundations and specialized personnel to test bio-equivalence of drugs;
b) Possessing all research results of bioequivalent reagents.
2. Organizations and individuals having bioequivalent reagents shall have the following responsibilities:
a / To pay compensations for damage caused to participants in bioequivalence tests if there are risks occurring due to bioequivalence tests according to the provisions of law;
b) To enter into a contract for bioequivalence testing with the bioequivalence testing facility of the drug;
c) To take responsibility before law for the quality and safety of the medicines they supply.
Article 99.- Rights and responsibilities of bioequivalence-testing establishments of drugs
1. Bioequivalence-testing establishments of drugs shall have the following rights:
a) Carry out clinical research and biological epidemiology analyzes in the bioequivalence test of the drug.
In the case of a biphasic analysis only, the contract or affiliation with the clinical trial acceptor clinic to the Good Clinical Trial Practice to perform the clinical trial phase in the trial the biological equivalent of the drug;
b) Conducting bioequivalence testing of medicines according to regulations;
c) Importing and purchasing chemicals, standard substances and samples in service of bioequivalence testing activities;
d) To use results of bioequivalence study of drugs according to agreements with organizations and individuals having bioequivalent reagents.
2. Bioequivalent receptors of drugs have the following responsibilities:
a / To bear responsibility for the results of bioequivalence study on the samples already tested;
b) To be responsible for the safety of participants in bioequivalence testing and compensation for damage to participants in bioequivalence testing if there is a risk due to the fault of the bioequivalence testing institution. according to the provisions of law;
c) To ensure truthfulness and objectivity in the bioequivalence test of drugs;
d / Being economically independent, organizing personnel for organizations and individuals that have bio-equivalent drugs.
Article 100. Principles for approval of bioequivalence testing of drugs
1. Bioequivalence testing of the drug shall be made only after the ethics committee for biomedical research has made a scientific and ethical review of the bioequivalence test file of the drug. and be handled by the person in charge of the biometric equivalent of the drug approval facility in writing.
2. The approval of bioequivalence tests of drugs must comply with the following basic principles:
a / Principles prescribed at Points a, b and c, Clause 2, Article 94 of this Law;
b) Compliance with Good Clinical Trials, Good Laboratory Practice in Biochemistry and in accordance with Bioequivalence Testing Guidelines issued by the Minister of Health.
3. Ethics Council in Basic Biomedical Research evaluates science and ethics in the study of bioequivalence testing dossiers of drugs and approves research protocols.
Article 101.- Bioequivalence dossiers and procedures of drugs
1. Bioequivalence test dossiers include:
a / A bioequivalence test application;
b / Drug information dossiers;
c) Biological equivalence test and demonstration protocols;
d / The scientific record of the researcher;
e) Information dissemination and volunteer cards participating in the study of participants in bioequivalence testing of drugs;
e) Drug labels.
2. Bioequivalence testing procedures of drugs are prescribed as follows:
a / To register for bioequivalence study of drugs;
b) Approving the bioequivalence study of drugs;
c / Organizing the bioequivalence testing of drugs;
d) Approving the results of bioequivalence testing of drugs.
3. The Minister of Health shall detail this Article.
Chapter XII
QUALITY STANDARDS, QUALITY STANDARDS AND INSPECTION OF MEDICINES, MEDICINAL MATERIALS, PACKAGING FOR DIRECT ACCESS TO DRUGS
Article 102.- Standards and quality standards of drugs, raw materials for manufacture of medicines and packages in direct contact with medicines
1. National technical regulations on drugs, raw materials for manufacture of medicines and packagings in direct contact with medicines, including technical regulations on quality of drugs, raw materials for manufacture of medicines and packages in direct contact with medicines. General testing is regulated in Vietnamese Pharmacopoeia. The application of testing methods in each treatise of drugs, raw materials for manufacture of medicines and packages in direct contact with medicines shall be effected on the basis of the principles of voluntary application.
2. Standards on quality of drugs, raw materials for manufacture of medicines and packages in direct contact with drugs are provided for as follows:
a / The national standards on drugs, drug raw materials and packages in direct contact with medicines shall be evaluated and publicized by the Ministry of Health and the Ministry of Science and Technology according to the provisions of the Law on Standards and Norms. Technology;
b / The establishments’ norms shall be directly contacted by drug production establishments, drug materials and packagings for use within the scope of operation of their establishments but must not be lower than national technical regulations. The corresponding provisions in the Pharmacopoeia of Vietnam. In cases where the Vietnamese Pharmacopoeia does not yet have national technical regulations on medicines, raw materials for manufacture of medicines or packages in direct contact with corresponding medicines, establishments shall elaborate standards on the basis of scientific research results or Regulations of the foreign pharmacopoeia and approved by the Ministry of Health.
3. The Minister of Health shall promulgate the Vietnamese Pharmacopoeia on the basis of the national standards on medicines, raw materials for making medicines and packings in direct contact with medicines and prescribe the application of foreign pharmacopoeias in Vietnam.
Article 103.- Examination of drugs, raw materials for manufacture of medicines and packages in direct contact with medicines
1. Examination of medicines, raw materials for drug manufacture and packaging, which come in direct contact with medicines, means the sampling and examination of technical standards and the corresponding and necessary tests for identification of drugs and raw materials for drug manufacture. Packaging directly exposed to drugs meeting the quality standards to decide on the acceptance or removal of drugs, raw materials for drug manufacture, packaging and direct contact with medicines.
2. Raw materials for making drugs and packages in direct contact with medicines before being put into the production of drugs must be tested and qualified by drug manufacturers.
3. Drugs, raw materials for drug manufacture and packages in direct contact with medicines before being released from the factory must be directly contacted by drug manufacturers, raw materials for drug manufacture, packaging and testing. quality.
4. The following drugs, apart from being tested under the provisions of Clause 3 of this Article, must also be tested by drug-testing establishments designated by competent state agencies before circulation:
a) Vaccines;
b) Biological products are serum containing antibodies;
c / Other drugs prescribed by the Minister of Health, based on the results of assessment of risks of drug quality and the evolution of the quality of the medicines produced or imported.
5. The Minister of Health shall detail this Article.
Article 104.- Establishments for testing drugs and raw materials for drug manufacture
1. Establishments for testing drugs and raw materials for drug production include:
a / Establishments for testing drug and drug materials of the State;
b / Establishments providing drug testing services and drug materials;
c / The testing laboratory of the pharmaceutical trading establishment.
2. The establishments for testing the State’s medicines and drug materials shall have the following responsibilities:
a / To inspect and determine the quality of drugs, raw materials for manufacture of medicines or packages in direct contact with medicines;
b / Examining and evaluating the quality and appraising quality standards of drugs, raw materials for making drugs and packages in direct contact with medicines at the request of the Health Ministry;
c / To consult and propose to the Minister of Health technical measures to enhance the management of medicine quality suitable to the socio-economic development conditions;
d / To ensure truthfulness and objectivity in the testing of drugs, raw materials for drug manufacture, packaging in direct contact with drugs;
e / To bear responsibility for the test results for drug samples, drug materials and packages in direct contact with the tested drugs.
3. Establishments providing drug testing services and drug materials shall have the responsibilities defined in Clause 2, Article 51 of this Law.
4. Testing laboratories of drug-dealing establishments shall take responsibility for inspection and testing to determine the quality of drugs, raw materials for manufacture of drugs or packages in direct contact with medicines of establishments.
5. The Prime Minister shall promulgate plannings on the system of testing by the State, establishments providing services of testing drugs and raw materials for drug manufacture; To stipulate the organizational system, material foundations and operation of the State establishments for testing drugs and drug materials.
Article 105.- Settlement of complaints about the conclusions on the quality of drugs, raw materials for making drugs or packages in direct contact with medicines
1. Pharmaceutical business establishments shall have the right to complain about the conclusions on the quality of drug, drug raw materials or packages in direct contact with medicines of competent state management agencies in charge of pharmacy.
2. In case of complaints about the conclusions on the quality of drugs, raw materials for drug manufacture or direct contact with medicines, the Ministry of Health shall designate establishments to test drugs and raw materials for drug manufacture with minimum conditions. Equivalent to the testing establishment which causes the disputes to be tested for re-testing of drugs, raw materials for drug manufacture, and packaging in direct contact with the drug with which the complaint is made.
Competence and procedures for settling complaints about the conclusion of quality of drugs for drug production or packaging in direct contact with medicines shall comply with the provisions of the legislation on complaints.
Chapter XIII
PRICE MANAGEMENT OF DRUGS
Article 106.- Principles for state management of drug prices
1. To manage market prices of medicines according to the market mechanism, to respect the right to self-determination and price competition of drug-trading organizations and individuals according to the provisions of law.
2. To ensure publicity and transparency of drug prices when circulating drugs on the market.
3. To protect the legitimate rights and interests of business organizations, consumers and the interests of the State.
4. To take measures to stabilize prices and use other measures to manage drug prices suitable to socio-economic development conditions in each period.
Article 107.- Measures for management of drug prices
1. Bidding for national reserve medicines according to the provisions of the Bidding Law and the legislation on national reserves; To purchase drugs purchased from the state budget, the health insurance fund, revenues from medical examination and treatment services and other lawful revenue sources of public medical establishments according to the provisions of the Bidding Law. except for cases specified in Clause 2 of this Article.
2. Bidding or placing orders or assigning plans for drugs in service of national target programs, national defense and security, epidemic prevention and control, and overcoming the consequences of natural calamities or disasters according to the provisions of law. On the provision of services and public-utility products.
3. To declare drug prices before market circulation and re-declare the change in declared drug prices.
4. To post up the wholesale prices and retail prices of drugs in Vietnam dong at the transaction places or drug-selling places of drug-dealing establishments; Printing, stamping or affixing the retail price on the package containing the medicine or outer package of the medicine; Public notice on the board, on paper or in other forms.
5. To take measures to stabilize drug prices according to the provisions of the price law for drugs on the list of essential medicines subject to abnormal fluctuations in prices or fluctuation in prices affecting the socio-economic stability. Assembly.
6. To negotiate prices for bidding packages for the purchase of drugs and materia medica from only 1 to 02 manufacturers, original brand-name drugs, rare drugs, medicines for the duration of copyright, drugs with non-popular contents variables and other specific cases.
7. To prescribe the maximum retail sale of drugs at drug-retailing establishments within the premises of medical examination and treatment establishments.
8. The Government shall detail this Article.
Article 108.- Responsibilities for state management of drug prices
1. The Government shall perform the unified State management over medicine prices.
2. The Health Ministry shall take responsibility before the Government for performing the State management over drug prices.
3. Ministries and ministerial-level agencies shall, within the ambit of their respective tasks and powers, coordinate with the Ministry of Health in performing the State management over drug prices.
4. Provincial-level People’s Committees shall, within the scope of their respective tasks and powers, perform the State management over drug prices in their respective localities.
Article 109.- The Ministry of Health’s responsibility for State management over drug prices
To assume the prime responsibility for, and coordinate with the Ministry of Finance, ministries, ministerial-level agencies, government-attached agencies and provincial-level People’s Committees in performing the State management over drug prices, with the following tasks:
1. To assume the prime responsibility for elaborating and submitting to competent state agencies for promulgation or promulgating according to its competence and organizing the implementation of policies and legislation on drug prices;
2. To request ministries, ministerial-level agencies, government-attached agencies and provincial-level People’s Committees to make regular and irregular reports on the State management over drug prices;
3. To assume the prime responsibility for organizing the dissemination and education of legislation on drug prices;
4. To assume the prime responsibility for, and coordinate with the Ministry of Finance in, implementing measures to stabilize drug prices according to the provisions of law on prices;
To assume the prime responsibility for, and coordinate with the Ministry of Finance in, specifying the drug price declaration and principles for reviewing and announcing drug prices declared and exported by the importing or exporting enterprises;
6. To organize the receipt and revision of prices of imported drugs declared and re-declared by imported or -imported establishments; prices of domestically produced drugs declared by the production establishments;
7. To guide the listing of drug prices at drug-dealing establishments;
8. To publish on the portal of the Ministry of Health the following information:
a / The wholesale and retail prices of drugs already declared;
b / Bid-winning drug prices supplied by Vietnam Social Insurance and medical establishments;
c / Drugs on the list of essential drugs, when there are abnormal price fluctuations or fluctuating price levels, which affect socio-economic stability;
9. Examining, inspecting and sanctioning violations of law on drug prices.
Article 110.- The Ministry of Finance’s responsibility for State management over drug prices
1. To coordinate with the Health Ministry in performing the following tasks:
a / To specify the drug price declaration and the principles for considering and announcing drug prices declared and exported by the producing or importing enterprises;
b / To apply measures to stabilize drug prices according to the provisions of law on prices;
c / Examining, inspecting and sanctioning violations of legislation on drug prices.
2. To set prices for drugs which are ordered by competent state agencies and assigned with plans of the central budget.
Provide the Ministry of Health with information on the actual import prices (CIF prices) of medicines imported into Vietnam.
Article 111.- The Ministry of Industry and Trade’s responsibility for State management over drug prices
1. Supply of information on prices of medicines and drug materials in countries in the region and in the world at the proposal of the Ministry of Health in service of state management of drug prices.
2. To coordinate with the Health Ministry in examining, inspecting and sanctioning violations of legislation on drug prices.
Article 112. Responsibility for state management of drug prices by provincial-level People’s Committees
1. To exercise the State management over drug prices in their provinces or centrally run cities according to the provisions of this Law and relevant law.
2. To monitor and report to the Ministry of Health and the Ministry of Finance information on drug price situation in their respective locality when there is abnormal fluctuation in price or fluctuation in price which affects socio-economic stability.
3. Organizations receiving and reviewing prices of domestically produced drugs shall be re-declared and reported to the Ministry of Health for publication at the Ministry of Health’s website.
4. Examining, inspecting and sanctioning violations of legislation on drug prices in localities under their respective management.
Article 113.- Responsibilities of the Vietnam Social Insurance in managing drug prices
To announce the bid-winning prices on the Vietnam Social Insurance website and supply bid-winning drugs to the Health Ministry within 5 days after receiving the contractor’s selection results from the establishments. drug tender.
Article 114.- Responsibilities of establishments conducting drug bidding
1. Within 10 days after the results of the bid win result, the establishments bidding drugs under the management of the provincial-level People’s Committees must send them to the provincial / municipal Health Services and Social Insurance Services; Other medical establishments conducting drug bidding shall send their drug-winning results to the Ministry of Health and the Vietnam Social Insurance.
2. Within 10 days after winning results of bidding for provinces and centrally-run cities, organizing the bidding for concentrated drugs, the provincial / municipal Health Services shall have to report on the bid-winning results to the Ministry of Health and Social Insurance of Vietnam
Chapter XIV
TERMS ENFORCEMENT
Article 115. Transition provision
1. Establishments trading in pharmaceuticals which have been granted certificates of eligibility for pharmaceutical business under the provisions of the Pharmacy Law No. 34/2005 / QH11 may continue trading in drugs till the expiry date of the certificates of eligibility trade in pharmaceuticals.
In cases where the certificates of full satisfaction of pharmaceutical business conditions do not state the validity term, the establishments shall be allowed to trade to the expiry of the time limit inscribed in the granted good practice certificates.
2. Dossiers of application for grant or re-grant of pharmaceutical practice certificates, certificates of full satisfaction of pharmaceutical business conditions and drug registration dossiers submitted before the effective date of this Law shall comply with the provisions of the Pharmacy Law. 34/2005 / QH11, except for cases where the establishment requests to comply with the provisions of this Law. Pharmaceutical practitioners who have been granted pharmaceutical practice certificates under the provisions of the Pharmacy Law No. 34/2005 / QH11 may continue their pharmaceutical practice till the expiry of the validity duration of the granted pharmaceutical practice certificates.
3. For persons having pharmaceutical practice certificates granted before the effective date of this Law, the time limit for updating professional knowledge shall be counted from the date this Law comes into force.
4. For pharmaceutical practice certificates which are granted before the effective date of this Law but expire after the effective date of this Law, their pharmaceutical practice certificates shall be re-granted according to the provisions of this Law.
5. For certificates of full satisfaction of pharmaceutical business conditions granted before the effective date of this Law which expire after the effective date of this Law, they must request the granting of pharmaceutical trading eligibility certificates. the provisions of this Law.
Article 116.- Effect of implementation
1. This Law takes effect from January 1, 2017.
2. Regulations on the application of good manufacturing practice principles and standards at drug-material-manufacturing establishments; Certificates of eligibility for pharmaceutical business, for establishments producing pharmaceutically acceptable excipients, capsules and medicine production and processing establishments; The pharmacists of the medical examination and treatment establishments, drugstores and other establishments engaged in prescription drug use activities shall take effect as from January 1, 2021.
3. The Government shall stipulate the roadmap for the implementation of Clause 2 of this Article, ensuring that up to January 1, 2021, hospitals of grade 1 or higher shall have to organize clinical pharmacy activities defined in Article 80 of this Law; All job positions specified in Article 11 of this Law must have pharmaceutical practice certificates.
4. Pharmaceutical Law No. 34/2005 / QH11 shall cease to be effective from the effective date of this Law.
5. The Government and competent state agencies shall detail and guide the implementation of articles and clauses assigned in the Law.
This Law was passed on April 6, 2016 by the XIIIth National Assembly of the Socialist Republic of Vietnam at its 11th session.
PRESIDENT OF CONGRESS
NGUYEN THI KIM NGAN