Chapter I
GENERAL PROVISIONS
Article 1.- Governing scope and subjects of application
1. This Law provides for drug trading; drug registration and circulation; drug use; drug supply; drug information and advertisement; clinical trial of drugs; management of habit-forming drugs, psychotrops, pre-substances used as drugs and radioactive drugs; drug quality standards and drug assay.
2. This Law applies to domestic and foreign agencies, organizations and individuals in Vietnam.
Where international treaties to which the Socialist Republic of Vietnam is a contracting member contain provisions different from those of this Law, the provisions of such international treaties shall apply.
Article 2.- Interpretation of terms
In this Law, the following terms shall be construed as follows:
1. Pharmacy means drugs and drug-related activities.
2. Drugs mean substances or mixtures of substances for human use for purposes of prophylaxis, therapy or diagnosis of disease or modification of physiological functions of human bodies, and consist of finished drugs, raw materials for drug manufacture, vaccines and medical biological products other than functional foods.
3. Vaccines mean preparations containing antigens that provoke immune responses of human bodies, and used for the purpose of prophylaxis.
4. Medical biological products mean products of biological origin used for the purposes of prophylaxis, therapy and diagnosis of human diseases.
5. Raw materials for drug manufacture means substances constituting products in the process of drug manufacture.
6. Pharmaceutical ingredients (also called active ingredients) mean substances or mixture of substances with therapeutic activity, which are used in drug manufacture.
7. Finished drugs mean medicinal product forms that have undergone all stages of manufacture, including packaging in their final containers and labeling.
8. Drugs from materia medica mean those manufactured from raw materials of natural animal, plant or mineral origin.
Drugs containing pure active ingredients extracted from materia medica, drugs being a combination of materia medica and synthetic chemical active ingredients are not called drugs from materia medica.
9. Traditional medicaments mean drugs prepared from materia medica under theories and by methods of traditional medicine of oriental countries.
10. Prescription drugs mean those which may cause hazards to human life or health if they are used not in accordance with indications of prescribers; require specific prescriptions when being dispensed, retailed or used; and are included in the list of prescription drug groups.
11. Non-prescription drugs mean those which, when being dispensed, sold or used, require no specific prescription.
12. Habit-forming drugs means those which, when being used for a prolonged period, may form bad habits, and are included in the list of habit-forming drugs promulgated by the Health Minister and compliant with treaties to which the Socialist Republic of Vietnam is a contracting party.
13. Psychotrops mean drugs which have effects on the central nervous system, may lead to users’ dependence if not used properly, and are included in the list of psychotrops promulgated by the Health Minister and compliant with treaties to which the Socialist Republic of Vietnam is a contracting party.
14. Pre-substances used as drugs mean chemicals which are indispensable to the process of preparation and manufacture of habit-forming drugs or psychotrops, are used as formula components of habit-forming drugs or psychotrops, and included in the list of pre-substances promulgated by the Health Minister and compliant with treaties to which the Socialist Republic of Vietnam is a contracting party.
15. Radioactive drugs mean those containing one or more radioactive substances, and used for diagnosis or treatment of disease.
16. Essential drugs mean those satisfying healthcare demands of a vast majority of people, and included in the list of essential drugs promulgated by the Health Minister.
17. Main drugs mean those satisfying treatment demands of medical examination and treatment establishments, compatible with the disease structure in Vietnam, and included in the list of main drugs for use in medical examination and treatment establishments promulgated by the Health Minister.
18. New drugs means those containing new pharmaceutical ingredients or those with a new combination of pharmaceutical ingredients already in circulation.
19. Specifics mean drugs having trade names given by manufacturing establishments and different from original names or international generic names.
20. Adverse reactions of drugs mean undesirable effects of drugs harmful to health, which may appear at normal doses.
21. Expiry date of drugs means use duration fixed for a specific lot of drug, after which such drug is no longer permitted for use.
22. Drug quality standards include regulations on criteria, technical requirements, assay methods, packaging, labeling, transportation, preservation and other requirements related to quality of drugs.
Drug quality standards are expressed in the form of technical documents.
23. Drugs of inferior quality mean those which are not up to quality standards already registered with competent agencies.
24. Counterfeit drugs mean products manufactured in any form of drug with a deceitful intention, and falling into one of the following cases:
a/ They have no pharmaceutical ingredients;
b/ They have pharmaceutical ingredients, which are, however, not at registered contents;
c/ They have pharmaceutical ingredients different from those listed in their labels;
d/ They imitate names and industrial designs of drugs which have been registered for industrial property protection of other manufacturing establishments.
25. Drug trading means the performance of one, a number or all of the stages of the investment process, from manufacture to sale of drugs or provision of drug-related services in the market for profit-making purposes.
26. Pharmacy practice means the use of pharmaceutical qualifications of individuals for drug trading.
27. Good practice means sets of principles and standards promulgated by the Health Ministry for manufacture, preservation, assay and circulation of drugs, and culture, cultivation, harvest and processing of materia medica.
28. Pre-clinical drug trial means scientific activities of studying the effects of drugs in order to evaluate and prove the effectiveness and safety of drugs on animals, as a procedural step for clinical trial.
29. Clinical drug trial means scientific activities of systematically studying the effects of drugs on human beings for the purpose of determining clinical effectiveness, recognizing and detecting adverse reactions of studied products; the absorption, distribution, metabolism and excretion of such products for the purpose of ascertaining the safety and effectiveness of drugs.
30. Drug information means activities of gathering and supplying information related to drugs to organizations or individuals directly engaged in medical or pharmaceutical activities or drug users.
31. Drug assay means the sampling and examination of technical standards, performance of corresponding and necessary tests for the purpose of determining whether or not raw materials, semi-finished products or finished products meet the technical standards before deciding to accept or reject such drugs.
32. Drug price declaration means reporting by drug-trading establishments to competent state agencies on expected import prices, wholesale prices and retail prices according to the provisions of law on prices.
Article 3.- State policies on pharmacy
The State shall materialize the following policies on pharmacy:
1. To develop pharmacy into a spearhead techno-economic branch, and prioritize the development of the pharmaceutical industry.
Projects on application of advanced technologies to manufacture of drugs, raw materials for drug manufacture, main drugs, drugs as substitutes for imported drugs, drugs for prevention and treatment of social diseases, vaccines, medical biological products, drugs from materia medica and traditional medicaments shall enjoy the investment preferences provided for by law;
2. To encourage organizations and individuals at home and broad as well as overseas Vietnamese to conduct scientific research into preparation technologies and biotechnologies for manufacturing new drugs; to invest in production of raw materials for drug manufacture and finished drugs suitable to the disease structure and drug use demands of people;
3. To encourage research into and inheritance of traditional medicine recipes and experiences, and harmoniously combine traditional medicine and modern medicine as well as pharmacy; to explore, exploit and use new materia medica and export materia medica; to materialize policies on preferences and supports for culture and planting of materia medica, rational exploitation of natural materia medica, thus ensuring the preservation and development of genetic sources of materia medica; to modernize the manufacture of drugs from materia medica;
4. To provide drug-related supports in appropriate forms to social policy beneficiaries, areas inhabited by ethnic minority people, areas being under particularly difficult socio-economic conditions and areas under difficult socio-economic conditions;
5. To develop a network of circulation, distribution and supply of drugs, thus ensuring sufficient quality drugs to meet the people's drug use demands;
6. To protect lawful rights and interests of organizations and individuals in drug research, trading and use in Vietnam.
Article 4.- National drug reserve
1. The State sets up a national reserve of drugs for use for the following purposes:
a/ Preventing and combating diseases and epidemics, and overcoming consequences of natural calamities or catastrophes;
b/ Maintaining defense and security;
c/ Contributing to stabilizing the drug market.
2. The setting up, organization, management, administration and use of the national drug reserve shall comply with the provisions of law.
Article 5.- State management over drug prices
1. The State manages drug prices on the principle that drug-manufacturing, exporting, importing or trading establishments shall fix prices by themselves, compete with one another in price and bear responsibility therefor before law; and takes measures to stabilize market prices of drugs in service of public healthcare.
2. The Government stipulates in detail the management of drug prices suitable to the socio-economic situation in each period on the following principles:
a/ Drugs, before being circulated in the market, must have their prices declared or re-declared in case of any change thereof by manufacturing or importing establishments with competent state agencies, ensuring that drug prices at home are not higher than drug prices in regional countries which have healthcare and commercial conditions similar to Vietnam's;
b/ Drug-manufacturing or -importing establishments must be responsible before law for their declared prices;
c/ Drug wholesale or retail prices must be posted up;
d/ Competent state agencies shall publicly announce declared drug prices; and periodically announce ceiling prices of drugs paid with the state budget and medical insurance;
e/ The Health Ministry shall assume the prime responsibility for, and coordinate with the Finance Ministry, the Industry Ministry, the Trade Ministry, the Planning and Investment Ministry and other concerned state agencies in, performing the state management over drug prices as assigned by the Government.
Article 6.- Agencies in charge of state management over pharmacy
1. The Government performs the unified state management over pharmacy.
2. The Health Ministry is answerable to the Government for performing the state management over pharmacy.
3. Ministries and ministerial-level agencies shall have to coordinate with the Health Ministry in performing the state management over pharmacy under the Government's assignment.
4. People's Committees at all levels perform the state management over pharmacy within their respective localities, as decentralized by Government.
Article 7.- Pharmacy inspectorate
The pharmacy inspectorate under the Health Ministry's Inspectorate has the function of specialized inspection of pharmacy.
The organization, functions, tasks and powers of the pharmacy inspectorate shall comply with the provisions of law on inspection.
Article 8.- Pharmaceutical societies and associations
1. Pharmaceutical societies and associations are socio-professional organizations of pharmacists and persons engaged in pharmacy.
2. Pharmacists and persons engaged in pharmacy have the right to join and found pharmaceutical societies and associations.
3. The organization and operation of pharmaceutical societies and associations shall comply with the provisions of law.
Article 9.- Prohibited acts
1. Trading in drugs without certificates of satisfaction of drug trading conditions.
2. Practicing pharmacy without pharmacy practice certificates.
3. Trading in drugs of unidentified origins, counterfeit drugs, drugs of inferior quality, expired drugs, drugs on the list of drugs banned from import, drugs subject to clinical trials, drugs not yet permitted for circulation, sample drugs used for registration or introduction to medical doctors.
4. Forging, renting, borrowing, leasing or lending pharmacy practice certificates or certificates of satisfaction of drug trading conditions.
5. Supplying untruthful information on or making untruthful advertisements for drugs, causing consumers' confusion; advertising drugs in contravention of historical and cultural traditions, ethics, fine traditions and customs of the Vietnamese nation.
6. Selling drugs at places which are not lawful drug-selling establishments.
7. Taking advantage of monopoly in drug trading to earn illicit profits, dumping drugs, raising drug prices in contravention of law.
8. Conducting drug sale promotion in contravention of law.
9. Selling drugs belonging to national target programs and aid drugs which are not for sale according to regulations; drugs supplied as humanitarian aid and non-commercially imported drugs.
10. Retailing prescription drugs without prescription.
11. Taking advantage of drug prescription to seek personal benefits.
12. Destroying precious materia medica sources.
13. Other acts which are strictly prohibited in pharmaceutical activities according to the provisions of law.
Tìm kiếm
Luật Dược 2005 (Bản Word)