Law on Medicines No. 34/2005/QH11

LAW

Pharmaceuticals

__

BASED ON THE CONSTITUTION OF THE SOCIALIST REPUBLIC OF VIETNAM IN 1992 AS AMENDED AND COMPLEMENTED BY RESOLUTION NO. 51/2001/QH10 DATED DECEMBER 25, 2001 OF THE TENTH NATIONAL ASSEMBLY SESSION 10;

This Law regulates activities in the pharmaceutical field.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Law stipulates the business of drugs; drug registration and circulation; drug use; drug supply; drug information and advertising; clinical drug trials; management of addictive drugs, psychotropic drugs, precursor chemicals for drug production, and radioactive drugs; drug quality standards and drug testing.

2. This Law applies to agencies, organizations, and individuals both within and outside Vietnam.

In cases where international treaties to which the Socialist Republic of Vietnam is a party provide different provisions from those of this Law, the provisions of such international treaties shall be applied.

Article 2. Interpretation of Terms

In this Law, the following terms shall be understood as follows:

1. Pharmaceuticals include drugs and activities related to drugs.

2. Drugs are substances or mixtures of substances intended for human use for the purpose of preventing, treating, diagnosing diseases, or regulating physiological functions of the body, including finished drugs, raw materials for drug production, vaccines, medical biological products, except functional foods.

3. Vaccines are preparations containing antigens that enable the body to develop immune responses, used for disease prevention.

4. Medical biological products are biologically sourced products used for disease prevention, treatment, and diagnosis in humans.

5. Raw materials for drug production are components participating in the formulation of products during the drug manufacturing process.

6. Active pharmaceutical ingredients (also called active substances) are substances or mixtures of substances with therapeutic activity used in drug production.

7. Finished drugs are drug forms that have undergone all stages of production, including final packaging and labeling.

8. Traditional medicine drugs are drugs produced from natural sources derived from animals, plants, or minerals.

Drugs containing purified active ingredients extracted from traditional medicines, or drugs combining traditional medicines with synthetic chemical active substances, are not considered traditional medicine drugs.

9. Traditional Chinese medicine drugs are drugs made from traditional medicines, prepared according to the theories and methods of traditional Eastern medicine.

10. Prescription drugs are drugs whose misuse without a prescription may endanger life or health; their distribution, retail sale, and use must follow a prescription and be listed in the prescription drug category.

11. Over-the-counter drugs are drugs that can be distributed, sold, and used without a prescription.

12. Addictive drugs are drugs that, if used over time, may lead to addiction, as specified in the list of addictive drugs issued by the Minister of Health and consistent with international treaties to which the Socialist Republic of Vietnam is a party.

13. Psychotropic drugs are drugs affecting the central nervous system, whose misuse may lead to dependence, as specified in the list of psychotropic drugs issued by the Minister of Health and consistent with international treaties to which the Socialist Republic of Vietnam is a party.

14. Precursor chemicals for drug production are indispensable chemicals in the preparation and production of addictive and psychotropic drugs, forming part of the formula of addictive and psychotropic substances, as specified in the list of precursors issued by the Minister of Health and consistent with international treaties to which the Socialist Republic of Vietnam is a party.

15. Radioactive drugs are drugs containing one or more radioactive substances, used for diagnosis or treatment.

16. Essential drugs are drugs meeting the healthcare needs of the majority of the population, as specified in the list of essential drugs issued by the Minister of Health.

17. Main drugs are drugs meeting the treatment needs in healthcare facilities appropriate to the disease structure in Vietnam, as specified in the list of main drugs used in healthcare facilities issued by the Minister of Health.

18. New drugs are drugs containing new active ingredients or new combinations of existing active ingredients.

19. Brand-name drugs are drugs bearing a trade name established by the drug manufacturer, distinct from the generic name or international nonproprietary name.

20. Adverse drug reactions are harmful effects on health that may occur at normal dosages.

21. The expiration date of a drug is the period of time designated for a batch of drugs beyond which the drug may not be used.

22. Drug quality standards include specifications, technical requirements, testing methods, packaging, labeling, transportation, storage, and other relevant requirements concerning drug quality.

Drug quality standards are expressed in technical documentation.

23. Substandard drugs are drugs that do not meet the registered quality standards with the competent authority.

24. Fake drugs are products manufactured in the form of drugs with the intent to deceive, falling under one of the following categories:

a) Containing no active ingredient;

b) Containing an active ingredient but not in the registered quantity;

c) Containing an active ingredient different from that stated on the label;

d) Imitating the name or design of a drug protected by industrial property rights of another manufacturer.

25. Drug business involves implementing one or more stages of the investment process from drug production to consumption or providing services related to drugs in the market for profit-making purposes.

26. Pharmaceutical practice is the use of pharmaceutical expertise by individuals to engage in drug business.

27. Good practices are principles and standards for the production, storage, testing, circulation of drugs, cultivation, harvesting, and processing of medicinal herbs issued by the Ministry of Health.

28. Preclinical drug testing is scientific research aimed at evaluating and proving the efficacy and safety of drugs on animals to facilitate clinical trials.

29. Clinical drug testing is systematic scientific research on drugs conducted on humans to verify clinical efficacy, identify and detect adverse reactions caused by the study product; assess its absorption, distribution, metabolism, and excretion, with the aim of determining the safety and efficacy of the drug.

30. Drug information is the collection and provision of news related to drugs for organizations and individuals directly involved in medical and pharmaceutical activities or drug users.

31. Drug testing is the process of sampling, examining technical standards, conducting corresponding and necessary tests to determine whether raw materials, semi-finished products, finished products meet technical standards, thereby deciding on the acceptance or rejection of the drug.

32. Pricing declaration for drugs is the act of drug business establishments reporting to competent state authorities on import prices, wholesale prices, and anticipated retail prices in accordance with the law on pricing.

Article 3. State policy in the pharmaceutical field

The State implements the following policies in the pharmaceutical field:

1. Developing the pharmaceutical industry into a leading economic and technological sector, prioritizing the development of the pharmaceutical industry.

Projects applying advanced technology to produce drugs, drug ingredients, main drugs, substitute drugs for imported ones, drugs to prevent social diseases, vaccines, medical products, drugs from medicinal herbs, traditional Chinese medicine shall enjoy investment incentives as prescribed by law;

2. Encouraging domestic and foreign organizations and individuals, overseas Vietnamese to develop scientific research on drug formulation technology, biotechnology to produce new drugs; investing in producing drug ingredients and finished drugs suitable for disease structure and drug usage needs of the people;

3. Encouraging research and inheritance of traditional Chinese medicine prescriptions and experiences, harmoniously combining traditional Chinese medicine with modern Western medicine; seeking, exploiting, and using new medicinal herbs, exporting medicinal herbs; implementing preferential and support policies for growing medicinal herbs, rationally exploiting natural medicinal herbs, ensuring preservation and development of medicinal herb genetic resources; modernizing drug production from medicinal herbs;

4. Supporting drugs through appropriate forms for policy beneficiaries, ethnic minority regions, areas with particularly difficult socio-economic conditions, and areas with difficult socio-economic conditions;

5. Developing a network for drug circulation, distribution, and supply, ensuring sufficient quality drugs to meet the drug usage needs of the people;

6. Protecting the rights and legitimate interests of organizations and individuals in researching, trading, and using drugs in Vietnam.

Article 4. National Reserve of Drugs

1. The State implements the national reserve of drugs for the following purposes:

a) Preventing and controlling epidemics and mitigating the consequences of natural disasters and catastrophes;

b) Ensuring national defense and security;

c) Participating in stabilizing the drug market.

2. The construction, organization, management, operation, and utilization of the national reserve of drugs shall be carried out in accordance with the provisions of the law.

Article 5. State Management of Drug Prices

1. The State manages drug prices based on the principle that drug production, export, import, and trade establishments set their own prices, compete on price, and bear responsibility as prescribed by law; using measures to stabilize drug prices on the market to meet the needs of health care services for the people.

2. The Government shall provide detailed regulations on drug price management in line with the economic and social situation at each specific stage according to the following principles:

a) Drugs must declare their prices before entering the market, and when changing prices, they must re-declare them to the competent state authority, ensuring that drug prices do not exceed those in similar countries in terms of healthcare and trade conditions;

b) Drug production and import establishments shall be responsible under the law for declared prices;

c) Wholesale drug prices and retail drug prices must be publicly displayed;

d) Competent state authorities shall publicly announce declared drug prices; periodically publish maximum prices for drugs paid for by the state budget and health insurance;

đ) The Ministry of Health shall take the lead in coordinating with the Ministry of Finance, the Ministry of Industry, the Ministry of Trade, the Ministry of Planning and Investment, and other relevant state agencies to implement state management of drug prices according to the division of labor by the Government.

Article 6. State Management Authority for Medicines

1. The Government shall uniformly manage state administration over medicines.

2. The Ministry of Health shall be responsible before the Government for implementing state management over medicines.

3. Ministries and ministerial-level agencies shall have the responsibility to coordinate with the Ministry of Health in the implementation of state management over medicines according to the division of labor assigned by the Government.

4. People's Committees at all levels shall implement state management over medicines within their localities according to the decentralization by the Government.

Article 7. Drug Inspection

Drug inspection under the Ministry of Health's inspection body shall have the function of specialized inspection on drugs.

The organization, functions, tasks, and powers of drug inspection shall be implemented in accordance with the laws on inspection.

Article 8. Associations and Trade Unions for Drugs

1. Associations and trade unions for drugs are social-professional organizations of pharmacists and persons working in the field of drugs.

2. Pharmacists and persons working in the field of drugs have the right to participate in and establish associations and trade unions for drugs.

3. The organization and activities of associations and trade unions for drugs shall be carried out in accordance with the provisions of the law.

Article 9. Prohibited Acts

1. Engaging in drug business without a Certificate of Eligibility for Drug Business.

2. Practicing pharmacy without a Pharmacy Practice Certificate.

3. Engaging in drug business with drugs of unknown origin, source, counterfeit drugs, substandard drugs, expired drugs, drugs prohibited from importation, clinical trial drugs, unapproved drugs, sample drugs for registration or introduction to physicians.

4. Forgery, renting, lending, renting out, lending out the Pharmacy Practice Certificate, Certificate of Eligibility for Drug Business.

5. Providing false information or advertising drugs that cause confusion to consumers; advertising drugs contrary to the traditional history, culture, ethics, customs, and traditions of the Vietnamese people.

6. Selling drugs at places that are not legitimate drug-selling establishments.

7. Exploiting monopoly in drug business to gain improper benefits, selling drugs below cost price, increasing drug prices contrary to the provisions of the law.

8. Promoting drugs contrary to the provisions of the law.

9. Selling drugs under national target programs, aid drugs which are not allowed to be sold; humanitarian aid drugs and non-trade imported drugs.

10. Selling prescription drugs without a prescription.

11. Exploiting prescription writing for personal gain.

12. Destroying precious medicinal materials.

13. Other acts strictly prohibited in drug activities as provided by law.

Chapter II

DRUG BUSINESS

PART 1

 CONDITIONS FOR DRUG BUSINESS

Article 10. Forms of Drug Business

Drug business includes forms of production, export, import, wholesale, retail, drug storage services, and drug testing services.

Article 11. Conditions and Authority to Issue the Certificate of Eligibility for Drug Business

1. Drug business is a conditional business sector. Organizations, individuals engaged in drug business (hereinafter referred to collectively as drug business entities) must have a Certificate of Eligibility for Drug Business.

2. Drug business entities eligible for issuance of the Certificate of Eligibility for Drug Business must meet the following conditions:

a) Physical facilities, technical equipment, and personnel with the necessary professional qualifications for each form of drug business;

b) A professional manager in pharmacy who has been issued a Pharmacy Practice Certificate suitable for the form of drug business.

3. The authority to issue the Certificate of Eligibility for Drug Business is stipulated as follows:

a) The Ministry of Health shall issue the Certificate of Eligibility for Drug Business to drug manufacturing entities, drug storage service providers, and drug testing service providers;

b) Provincial and centrally-administered city Departments of Health shall issue the Certificate of Eligibility for Drug Business to drug business entities in other forms of drug business, except for the cases specified in point a of this clause.

4. The competent state agency as stipulated in Clause 3 of this Article shall be responsible for issuing the Certificate of Eligibility for Drug Business within thirty days from the date of receipt of complete valid files; if not issued, they must provide a written response stating the reasons.

5. The Government shall specify specific conditions for each form of drug business; the time limit, file requirements, procedures for issuance, supplementation, replacement, extension, and revocation of the Certificate of Eligibility for Drug Business.

Article 12. Business License for Drug Trading

1. The Business License for Drug Trading must clearly state the name, location, professional manager, trading form, trading scope of the business entity, and the validity period of the Business License for Drug Trading.

2. A drug trading business entity may only operate at the registered location and within the trading scope recorded in the Business License for Drug Trading; in case of expanding the trading scope or changing the trading location, it must complete supplementary procedures or replace the Business License for Drug Trading.

Article 13. Professional Practice Certificate for Pharmacists

1. Individuals granted a Professional Practice Certificate for Pharmacists must meet the following conditions:

a) Possessing appropriate academic degrees and certificates in accordance with the requirements of each type of drug trading;

b) Having practiced for at least two to five years at a legitimate pharmaceutical establishment for each type of trading;

c) Demonstrating professional ethics;

d) Being in good health to practice pharmacy.

2. The following individuals shall not be granted a Professional Practice Certificate for Pharmacists:

a) Those prohibited from practicing pharmacy according to court judgments or decisions;

b) Those currently under criminal investigation;

c) Those currently serving a criminal sentence or administrative sanction decision involving placement in an educational institution, medical facility, or administrative control;

d) Those currently under disciplinary action of warning or higher related to their medical or pharmaceutical profession;

đ) Those lacking full civil capacity or having limited civil capacity.

3. The authority to issue a Professional Practice Certificate for Pharmacists is stipulated as follows:

a) The Minister of Health issues a Professional Practice Certificate for Pharmacists to individuals applying to practice pharmacy with foreign investment capital;

b) The Director of the Department of Health issues a Professional Practice Certificate for Pharmacists to individuals applying to practice pharmacy, except in cases specified in point a of this clause;

4. The Government shall specify details regarding academic degrees and professional certificates, practical experience periods at pharmaceutical establishments for each type of drug trading; application forms, procedures for issuing, replacing, renewing, and revoking Professional Practice Certificates for Pharmacists.

Article 14. Fees for Issuing Business Licenses for Drug Trading and Professional Practice Certificates for Pharmacists

Drug trading business entities requesting a Business License for Drug Trading and individuals requesting a Professional Practice Certificate for Pharmacists must pay fees as prescribed by law.

PART 2

DRUG PRODUCTION

Article 15. Rights of Drug Manufacturing Entities

1. Enjoying preferential treatment on capital, land, taxes, and other benefits for producing drugs in fields specified in Article 3 of this Law and other relevant laws.

2. Providing information and advertising drugs in accordance with laws on advertising to promote and increase sales of products produced by the manufacturing entity.

3. Other rights as prescribed by law.

Article 16. Obligations of Drug Manufacturing Entities

1. Adhering to regulations on good practices in production, distribution, storage, testing of drugs, and other relevant professional regulations.

2. Producing drugs strictly in accordance with registered production processes and quality standards; reporting changes in production processes to competent authorities.

3. Being responsible for the quality of drugs produced and only allowing the release of drugs that meet registered quality standards.

4. Equipping technical means and professional staff to meet the requirements for drug quality inspection and management.

5. Retaining samples of drugs produced in each batch for at least one year after the drug's expiration date; keeping records of production and other necessary documents for comprehensive inspection and evaluation of drug production activities as prescribed by law.

6. Monitoring the quality of drugs produced circulating in the market and recalling drugs in accordance with the provisions of this Law.

7. Registering drugs; declaring prices before circulating drugs in the market.

8. Compensating users for damages caused by the manufacturing entity's fault.

9. Other obligations as prescribed by law.

Article 17. Medicines compounded at pharmacies and healthcare facilities

1. Medicines compounded according to prescriptions at pharmacies, medicines compounded at healthcare facilities do not need to be registered as drugs and can only be distributed or sold retail at those facilities. The compounding records must be kept for one year from the date of compounding.

2. The pharmacy owner and the professional drug management personnel at healthcare facilities shall be responsible for the quality of compounded medicines at their facilities; they must compensate for damages caused to users due to compounding errors.

Section 3

EXPORTING AND IMPORTING MEDICINES

Article 18. Rights and obligations of enterprises exporting and importing medicines

1. They have the right to export, import, act as agents for, and accept agency for the export and import of medicines as specified by the Ministry of Health.

2. They must comply with good practices in the storage and distribution of medicines and declare medicine prices.

3. They may only export and import medicines that meet quality standards and monitor and take responsibility for the quality of medicines circulating on the market through their export and import activities.

4. They must compensate for damages caused to users due to the fault of the exporting or importing enterprise.

5. Other rights and obligations as prescribed by law.

Article 19. Entrusting the Exporting and Importing of Medicines

1. Medicine trading establishments have the right to entrust the exporting and importing of medicines.

2. The entrusting of the exporting and importing of medicines shall be carried out in accordance with the Law on Trade and other relevant laws.

Article 20. Scope of Importing Medicines

1. Medicines registered in Vietnam may be imported without quantity restrictions, except for vaccines, medical products, and medicines listed under special control categories as stipulated in Article 63 of this Law.

2. Unregistered medicines may be imported in certain quantities in the following cases:

a) Containing active pharmaceutical ingredients that are unregistered or already registered but insufficient to meet treatment needs;

b) Meeting urgent needs for disease prevention and control, disaster relief, and special treatment requirements;

c) Serving national health target programs;

d) Aid and humanitarian assistance;

đ) Clinical trials, sample registration, participation in exhibitions and trade fairs;

e) Carried for personal medical treatment;

g) Other non-commercial import forms.

3. The Prime Minister shall specify the regulations for importing medicines as provided for in Clause 2 of this Article.

PART 4

WHOLESALE SALE OF MEDICINES

Article 21. Wholesale Medicine Establishments

Wholesale medicine establishments include:

1. Medicine trading enterprises;

2. Cooperatives and individual households producing and trading in medicinal herbs, traditional medicines, and medicines derived from medicinal herbs;

3. Vaccine and medical product distributors.

Article 22. Rights of Wholesale Medicine Establishments

1. Purchase raw materials for medicines, finished medicines, vaccines, and medical products from production establishments or wholesale medicine establishments.

2. Sell raw materials for medicines, finished medicines, vaccines, and medical products to establishments authorized to trade in medicines and healthcare facilities.

Article 23. Obligations of Wholesale Medicine Establishments

1. Store medicines in accordance with the conditions stated on the medicine labels.

2. Maintain the integrity of the packaging of medicines; they may not change the packaging or labels of medicines. In cases where the label or packaging of registered medicines is changed, such changes must be authorized by the medicine production establishment and approved in writing by the Ministry of Health.

3. Ensure that the handling, receipt, and storage of medicines are conducted by personnel with pharmaceutical expertise.

4. Retain documentation and records related to each batch of medicines for at least one year from the expiration date of the medicines.

5. Publish wholesale medicine prices and comply with other price management regulations.

6. Compensate for damages caused to users due to the fault of the wholesale medicine establishment.

7. Comply with good practices in the storage and distribution of medicines, recall procedures, and other relevant legal provisions.

PART 5

RETAIL OF MEDICINES

Article 24. Retail Medicine Outlets

1. Retail medicine outlets include:

a) Pharmacies;

b) Medicine counters;

c) Medicine retail agencies of enterprises;

d) Medicine cabinets of health stations.

2. Medical examination and treatment facilities and wholesale medicine outlets wishing to sell medicines at retail must establish retail medicine outlets.

3. The Minister of Health shall stipulate the areas where retail medicine outlets can be established in the forms of medicine counters, enterprise medicine retail agencies, and health station medicine cabinets in accordance with economic and social conditions, the current status of medical staff, and the healthcare needs of the people at each stage.

Article 25. Professional Conditions for Owners of Retail Medicine Outlets and Retail Medicine Sellers

1. The professional conditions for owners of retail medicine outlets are stipulated as follows:

a) Pharmacies must be headed by a pharmacist with a university degree;

b) Medicine counters must be headed by a pharmacist with a secondary education level or higher;

c) Enterprise medicine retail agencies must be headed by a person with a professional qualification from a pharmaceutical assistant level or higher;

d) Health station medicine cabinets must be headed by a person with a professional qualification from a pharmaceutical assistant level or higher; in cases where there is no person with a pharmaceutical assistant level or higher qualification, it must be headed by a person with a professional qualification from a medical assistant level or higher;

đ) Retail medicine outlets specializing in selling traditional Chinese medicine and herbal medicines must be headed by a pharmacist with a secondary education level or higher or a person holding a certificate in traditional medicine or traditional pharmacy.

2. Retail medicine sellers at retail medicine outlets specified in points a, b, c, and đ of Clause 1 of this Article must have a professional qualification from a pharmaceutical assistant level or higher; at point d of Clause 1 of this Article, they must have expertise in medicine and pharmacy.

Article 26. Scope of Operation of Retail Medicine Outlets

1. The scope of operation of retail medicine outlets is stipulated as follows:

a) Pharmacies may sell finished medicines; compound medicines according to prescriptions;

b) Medicine counters may sell finished medicines;

c) Enterprise medicine retail agencies may sell medicines according to the essential drug list;

d) Health station medicine cabinets may sell medicines according to the essential drug list for commune-level healthcare;

đ) Retail medicine outlets specializing in traditional Chinese medicine and herbal medicines may sell traditional Chinese medicine and herbal medicines.

2. Retail medicine outlets specified in points b, c, d, and đ of Clause 1 of this Article shall not sell addictive drugs or radioactive drugs.

Retail medicine outlets shall not sell raw chemical materials for making medicines.

3. The Minister of Health shall stipulate the conditions for pharmacies that compound medicines according to prescriptions.

Article 27. Rights of Retail Medicine Sellers and Owners of Retail Medicine Outlets

1. Retail medicine sellers have the following rights:

a) To sell medicines to users;

b) To refuse to sell medicines when prescriptions are not in compliance with regulations or when buyers are unable to follow necessary instructions;

c) A retail medicine seller who is a pharmacist with a university degree has the right to substitute one medicine for another with the same active ingredient, dosage form, and dosage upon the buyer's consent;

d) To exercise the rights of the owner of a retail medicine outlet within the scope of their authorization.

2. The owner of a retail medicine outlet has the following rights:

a) The rights stipulated in points a and b of Clause 1 of this Article;

b) To purchase medicines from wholesale medicine outlets for retail sale, and to buy raw materials for compounding medicines according to prescriptions;

c) To delegate authority to manage operations to employees with equivalent or higher professional qualifications when absent.

Article 28. Obligations of Retail Medicine Sellers and Owners of Retail Medicine Outlets

1. Retail medicine sellers shall have the following obligations:

a) Check prescriptions before selling;

b) Clearly mark the name and dosage of the medicine on the packaging when the medicine is sold unpackaged from its original outer packaging;

c) Sell only the medicines prescribed in the prescription, except in cases provided for in point c, Clause 1, Article 27 of this Law;

d) In cases where medicines are substituted according to the provisions of point c, Clause 1, Article 27 of this Law, they must clearly record the name, dosage, concentration, quantity of the substituted medicine, and the method of use on the prescription and be responsible for the substitution;

đ) Be liable to the owner of the retail medicine outlet for their actions within the scope of their authorization;

2. The owner of the retail medicine outlet shall have the following obligations:

a) Directly manage and oversee all activities of the outlet;

b) Display the operating hours for selling medicines; display retail prices on products, except when the retail price is printed on the product; shall not sell at a higher price than the displayed price;

c) Be legally responsible for all activities of the outlet, including in cases of delegation;

3. Retail sellers and owners of retail medicine outlets must compensate for damages caused by their own fault to users of medicines.

Section 6

MEDICINE STORAGE SERVICES

Article 29. Conditions for Enterprises Providing Medicine Storage Services

Enterprises providing medicine storage services must meet good practice standards for medicine storage.

Article 30. Rights of Enterprises Providing Medicine Storage Services

1. Accept storage of medicines for organizations and individuals under storage contracts;

2. Transport and deliver medicines to organizations and individuals upon authorization by the service user;

3. Receive remuneration for providing medicine storage services.

Article 31. Obligations of Enterprises Providing Medicine Storage Services

1. Store medicines in accordance with the storage requirements indicated on the medicine label and the contract between both parties;

2. Compensate for losses caused by violations during the storage and transportation of medicines.

Section 7

MEDICINE TESTING SERVICES

Article 32. Conditions for Enterprises Providing Medicine Testing Services

Enterprises providing medicine testing services must meet good practice standards for medicine testing. In cases where pharmaceutical enterprises' testing laboratories wish to provide medicine testing services, the enterprise must complete additional procedures to include the function of providing medicine testing services in the Certificate of Eligibility for Pharmaceutical Business Operations in accordance with the law.

Article 33. Rights of Enterprises Providing Medicine Testing Services

1. Test raw materials for medicines, semi-finished medicines, and finished medicines;

2. Provide test results for tested medicine samples;

3. Receive remuneration for providing medicine testing services.

Article 34. Obligations of Enterprises Providing Medicine Testing Services

1. Be responsible for the test results of tested medicine samples;

2. Compensate according to the law for organizations and individuals suffering losses due to incorrect test results.

Chapter III

REGISTRATION AND CIRCULATION OF MEDICINES

Article 35. Registration of Medicines

1. The basis for registering medicines includes:

a) Clinical trial results regarding the efficacy and safety of the medicine, except for medicines exempted from clinical trials as stipulated in Article 55 of this Law;

b) Technical documentation on the medicine;

c) National policy on medicines in Vietnam;

2. The registration entity must pay fees when submitting the application dossier in accordance with the law;

3. Within six months from the date of receiving a complete and valid application, the Minister of Health shall issue a registration number for the medicine; if not issued, a written response explaining the reasons must be provided;

4. The Minister of Health shall specify detailed procedures, application dossiers for medicine registration, the validity period of the registration number, and the procedure for revoking the registration number.

Article 36. Circulation of Medicines

1. Medicines circulating on the market must ensure the following conditions:

a) Meeting the registered quality standards;

b) Fully complying with the labeling requirements for medicines as stipulated in Article 37 of this Law and other relevant laws;

c) Packaging materials and packaging forms must meet the requirements to ensure the quality of medicines;

d) Having a registration number or not having a registration number but imported in accordance with point a and point b, Clause 2, Article 20 of this Law;

đ) Must be declared according to the price regulations of this Law; if it is imported medicine, the import price shall not be higher than the import price of such medicine in countries in the region with similar healthcare and trade conditions as Vietnam at the same time.

2. Domestic medicines produced for the national health program and imported medicines in accordance with points c, d, đ, and e, Clause 2, Article 20 of this Law must be used for their intended purposes and target groups; the labels of these medicines must comply with the provisions of Article 37 of this Law; individual packages of these medicines must bear the inscription "Not for Sale" except in cases provided for in point e, Clause 2, Article 20 of this Law.

Article 37. Labels of Medicines Circulating on the Market

1. The labels of medicines circulating on the market must include the following contents:

a) Medicine name;

b) Formulation type;

c) Composition of the medicine;

d) Packaging specifications;

đ) Name and address of the manufacturing facility;

e) Registration number, batch number, production date, expiration date;

g) Storage conditions and other necessary information.

In the case of a single active substance brand-name drug, the generic name or international non-proprietary name must be listed under the brand name.

2. Medicines must have usage instructions in Vietnamese.

Article 38. Recall of Medicines

1. Medicines circulating on the market shall be recalled in the following cases:

a) Incorrect type due to confusion during distribution or handover;

b) Not meeting the conditions specified in points a, b, c, and d, Clause 1, Article 36 of this Law;

c) There is a recall notice from the manufacturing facility, the competent state management agency for pharmaceuticals in Vietnam or abroad.

2. In cases of recall specified in point b and point c, Clause 1 of this Article, before recalling, there must be a decision to suspend circulation issued by the competent state management agency for pharmaceuticals in Vietnam.

3. Upon receiving a recall notice from the manufacturing facility or a decision to suspend circulation from the competent state management agency for pharmaceuticals in Vietnam, organizations and individuals engaged in medicine business, medical examination and treatment facilities, prescribers, and users of the recalled medicine must immediately cease selling, informing, advertising, prescribing, distributing, and using the recalled medicine.

4. Importers, manufacturers, registrants, and suppliers of medicines are responsible for organizing the recall of suspended medicines and compensating for damages caused according to the law.

The competent state management agency for pharmaceuticals is responsible for inspecting the organization of the recall of medicines.

5. The Minister of Health shall specify detailed procedures and formalities for recalling medicines, classify the levels of recall, scope of suspension of circulation, and handling of recalled medicines.

Chapter IV

TRADITIONAL MEDICINES AND MEDICINES FROM HERBAL MATERIALS

Article 39. Cultivation of medicinal plants and breeding of animals for medicine

The cultivation of medicinal plants, breeding of animals for medicine, and the processes of harvesting and extracting their products to make medicine must comply with good agricultural and collection practices.

Article 40. Quality of medicinal materials

Medicinal materials used for production, processing, or compounding prescriptions must ensure quality in accordance with regulations. Organizations and individuals supplying such materials must be responsible for their origin and quality.

Article 41. Storage of medicinal materials

1. Medicinal materials must be processed and stored in compliance with regulations after harvesting. Residue levels of plant protection chemicals and preservatives must not exceed permissible limits.

The Minister of Health shall stipulate conditions for processing and storing medicinal materials, permissible residue levels of plant protection chemicals and preservatives in medicinal materials.

2. During transportation, medicinal materials must be packaged. The packaging must bear labels indicating the name of the medicinal material, place of production, quality, and date of packaging.

Article 42. Sale of Traditional Medicine and Medicines from Medicinal Materials at Medical Facilities

Practitioners of Traditional Medicine, including Traditional Medicine Doctors, Traditional Medicine Attendants, and Traditional Medicine Experts working at medical facilities may sell Traditional Medicine and medicines from medicinal materials at these facilities.

Article 43. Registration and Circulation of Traditional Medicine and Medicines from Medicinal Materials

1. The registration of Traditional Medicine and medicines from medicinal materials shall be carried out in accordance with Article 35 of this Law and the following provisions:

a) All Traditional Medicine and medicines from medicinal materials produced domestically or imported for circulation on the market must be registered;

b) Prescribed decoctions compounded at Traditional Medicine medical facilities, raw medicinal materials, and tablets do not need to be registered. The owners of retail outlets and medical facilities must be responsible for the quality of these types of medicines.

2. The circulation and recall of Traditional Medicine and medicines from medicinal materials shall be carried out in accordance with Articles 36 and 38 of this Law.

3. Medicines that combine medicinal materials with purified active ingredients extracted from natural sources or synthetic chemical substances shall be regulated under this Law and shall not be registered as Traditional Medicine or medicines from medicinal materials.

Article 44. Production of Traditional Medicine and Medicines from Medicinal Materials

1. Facilities producing Traditional Medicine and medicines from medicinal materials, from the compounding of finished products to packaging, must comply with good manufacturing practices for Traditional Medicine and medicines from medicinal materials and follow the provisions set forth in Section II Chapter II of this Law.

2. Traditional Medicine and medicines from medicinal materials containing toxic, addictive, psychotropic, or precursor substances must clearly indicate the concentration, quantity, standards, and testing methods for those medicinal materials in technical documentation.

3. The Minister of Health shall promulgate a list and management regulations for medicinal materials containing toxic, addictive, psychotropic, or precursor substances.

Article 45. Export, Import, Wholesale, and Retail of Traditional Medicine and Medicines from Medicinal Materials

The export, import, wholesale, and retail of Traditional Medicine and medicines from medicinal materials shall be carried out in accordance with the provisions of Sections III, IV, and V Chapter II of this Law.

Chapter V

PRESCRIPTIONS AND USE OF MEDICINES

Article 46. Prescription

1. A prescription is a legal basis for selling medicine, distributing medicine, compounding medicine, weighing medicine according to the prescription, and using medicine. The name of the medicine recorded on the prescription must be the generic name or the international non-proprietary name, except in cases where the medicine contains multiple active ingredients.

2. The Minister of Health shall specify detailed regulations regarding prescriptions, groups of prescription medicines, and the sale of medicines based on prescriptions.

Article 47. Use of Medicines

1. The user of medicine has the right to choose a retail pharmacy to purchase medicine.

2. When using medicine according to a prescription, the user of medicine must follow the instructions recorded on the prescription. When using over-the-counter medicine, the user must follow the instructions on the medicine usage leaflet or the instructions provided by the retail pharmacy.

3. When using medicine, if the body exhibits unusual signs, the user of medicine must immediately inform the nearest healthcare facility, the prescriber, or the retail pharmacy so that appropriate measures can be taken promptly.

4. The prescriber and the owner of the retail pharmacy have the responsibility to report unusual signs exhibited by the user of medicine to the competent health authority. The prescriber is responsible for the prescription issued.

Chapter VI

SUPPLY OF MEDICINE IN HEALTH CARE FACILITIES

Article 48. Conditions for Supplying Medicine

1. The supply of medicine in healthcare facilities must comply with good distribution practices, storage regulations, and other relevant laws.

2. Those distributing medicine in healthcare facilities must distribute medicine strictly according to medical orders or prescriptions, clearly marking the name of the medicine and its dosage on the packaging, and providing guidance to the user.

3. Doctors, nurses, midwives, and nursing assistants may not sell medicine to patients, except as provided for in Article 42 of this Law.

Article 49. Ensuring Supply of Medicine

1. Healthcare facilities are responsible for ensuring sufficient supply of quality medicine within the main list of medicines used in healthcare facilities to meet emergency, diagnostic, and treatment needs at the facility.

The Minister of Health shall stipulate the list and stock of emergency medicines, the main list of medicines used in healthcare facilities, and the supply of medicines at state-owned healthcare facilities, excluding the procurement of medicines as specified in Clause 2 of this Article.

2. The procurement of medicines from the main list of state-owned healthcare facilities and medicines paid for by the state budget shall be carried out in accordance with the provisions of the law on bidding, ensuring the following principles:

a) Prioritize purchasing domestically produced medicines of the same type, equivalent quality, and no higher price than imported medicines;

b) The winning bid price for medicines shall not exceed the price periodically announced by the competent state authority as stipulated in Point d, Clause 2, Article 5 of this Law.

The Minister of Health shall coordinate with the Minister of Planning and Investment and the Minister of Finance to guide the procurement of medicines in accordance with the provisions of this clause.

Article 50. Compounding Medicine in Healthcare Facilities

1. Healthcare facilities meeting the standards and conditions for compounding medicine are permitted to compound medicine according to prescriptions for the treatment needs of the facility in accordance with Article 17 of this Law.

2. The Minister of Health shall stipulate the standards and conditions for compounding medicine in healthcare facilities.

Chapter VII

INFORMATION AND ADVERTISING OF MEDICINES

Article 51. Drug Information

1. Drug information aims to guide the rational and safe use of drugs for healthcare staff and drug users.

2. Drug information must be complete, objective, accurate, truthful, easy to understand, and not misleading.

3. Responsibilities for drug information are defined as follows:

a) Drug manufacturing, trading, and supply entities have the responsibility to provide drug information to healthcare staff and drug users.

b) Healthcare facilities have the responsibility to disseminate and manage drug information within their units.

c) Healthcare staff have the responsibility to provide relevant drug information to drug users during medical examinations and treatments.

d) State management agencies on pharmaceuticals have the responsibility to publicly disclose drug information.

4. Responsibilities for monitoring adverse drug reactions are defined as follows:

a) Medical examination and treatment facilities, healthcare staff have the responsibility to monitor and report adverse drug reactions to the facility's responsible person and competent drug management authorities.

b) During the circulation of drugs, drug manufacturing and distribution entities must monitor and report adverse drug reactions caused by their own manufactured and distributed drugs to the facility's responsible person and competent drug management authorities.

5. Organizations and individuals providing drug information must bear responsibility for the information they provide.

6. The Minister of Health has the responsibility to organize a drug information system and monitor adverse drug reactions to ensure the rational and safe use of drugs for the people; to stipulate activities related to drug information at healthcare facilities.

Article 52. Drug Advertising

1. Drug advertising shall be conducted by drug business entities or service advertisers and must comply with the provisions of the law on advertising.

2. It is prohibited to use material benefits, take advantage of the names of organizations or individuals, types of correspondence, clinical research results not recognized by the Ministry of Health, and similar methods to advertise drugs.

Article 53. Scope of Drug Advertising

1. Prescription drugs may not be advertised to the public in any form.

2. Over-the-counter drugs can be advertised through advertising media; in cases of advertising on radio and television, the following conditions must be met:

a) Contain active ingredients listed as permitted for radio and television advertising by the Ministry of Health;

b) Have a registration number in Vietnam that is still valid.

Chapter VIII

CLINICAL TRIALS OF DRUGS

Article 54. Clinical Trial Drugs

1. New drugs must undergo clinical trials.

2. Clinical trial drugs must meet the following requirements:

a) Have been studied in preclinical stages;

b) Have a stable formulation;

c) Meet quality standards according to the clinical trial registration dossier.

3. The label of clinical trial drugs must state: "Product for clinical trial use only. Prohibited for other purposes."

Article 55. Exemption from Clinical Trials or Certain Stages of Clinical Trials

1. Original name drugs.

2. Foreign drugs not yet registered in Vietnam but legally circulated for at least five years in their country of origin; widely used for many patients, confirmed by the competent authority of the producing country as safe and effective; having the same route of administration, dosage, and indications in Vietnam as in that country.

3. Traditional medicine prescriptions recognized by the Ministry of Health.

4. The Minister of Health shall specify the specific cases where drugs are exempted from clinical trials or certain stages of clinical trials.

Article 56. Conditions for Participants in Clinical Trials

1. Participants in clinical trials must be voluntary individuals who meet professional requirements and must sign a contract with the organization conducting the clinical trial, except for individuals with limited civil capacity, those without civil capacity, or those who have lost their civil capacity.

2. In cases where participants in clinical trials are under the age of majority, have limited civil capacity, or have lost their civil capacity, they must obtain the consent of their legal representatives.

3. The Minister of Health shall specify regulations for pregnant women participating in clinical trials.

Article 57. Rights of Participants in Clinical Trials

1. To be provided with full and truthful information before the clinical trial about the trial and potential risks.

2. To be compensated for damages caused by the clinical trial by the organization or individual with the drug undergoing clinical trial.

3. To keep personal information related to the trial confidential.

4. Not to be held responsible when unilaterally terminating the contract to participate in the clinical trial.

5. To lodge complaints and denunciations regarding violations of the law by organizations or individuals with drugs undergoing clinical trials and those receiving the clinical trial.

Article 58. Rights of Organizations and Individuals with Drugs Undergoing Clinical Trials

1. To select organizations that meet the provisions on infrastructure and professional staff to conduct drug trials on humans.

2. To own all research results of the drug undergoing clinical trials.

Article 59. Obligations of Organizations and Individuals with Drugs Undergoing Clinical Trials

1. Must apply for permission and obtain written approval from the Minister of Health before conducting a clinical trial.

2. To compensate participants in the clinical trial for damages if risks occur due to the clinical trial according to the law.

3. To enter into a contract regarding the drug trial on humans with the organization receiving the drug trial on humans.

Article 60. Rights of Organizations Receiving Drug Trials on Humans

1. To receive drugs and funding from organizations or individuals with drugs undergoing clinical trials to conduct clinical trials in accordance with the law.

2. To use the research results of drug trials on humans as agreed with organizations or individuals with drugs undergoing clinical trials.

Article 61. Obligations of Organizations Receiving Drug Trials on Humans

1. To comply with good clinical practice guidelines; report on the process and results of the clinical trial and urgent reports when necessary to the Ministry of Health.

2. To enter into contracts regarding drug trials on humans with organizations or individuals with drugs undergoing clinical trials and with participants in the clinical trial.

Article 62. Stages and Procedures for Drug Trials on Humans

1. Drug trials on humans must be conducted in stages and must comply with good clinical practice guidelines.

2. The Minister of Health shall specify detailed conditions, documentation, procedures, and stages of drug trials on humans.

Chapter I

MANAGEMENT OF DRUGS OF ADDICTION, PSYCHOTROPIC DRUGS, PRECURSOR CHEMICALS USED AS DRUGS AND RADIOACTIVE DRUGS

Article 63. Drugs Subject to Special Control

1. Drugs of addiction, psychotropic drugs, precursor chemicals used as drugs, and radioactive drugs are types of drugs subject to special control.

2. The Minister of Health shall promulgate a list of drugs subject to special control in accordance with international treaties to which the Socialist Republic of Vietnam is a party.

Article 64. Conditions for Operating and Using Special-Controlled Medicines

1. Business establishments, compounding facilities, and dispensing units dealing with special-controlled medicines must meet the business conditions for medicines as prescribed by the Government.

2. The importation, exportation, and transportation of special-controlled medicines shall be carried out in accordance with the provisions of the law.

3. Special-controlled medicines may only be used for disease prevention, treatment, diagnosis, physiological function adjustment, scientific research purposes, and not for other purposes.

Article 65. Responsibilities of Business Establishments, Compounding Facilities, and Dispensing Units Dealing with Special-Controlled Medicines

1. Business establishments, compounding facilities, and dispensing units dealing with special-controlled medicines have the responsibility to:

a) Report periodically or urgently to competent state management agencies;

b) Retain relevant documentation and records for each type of medicine for at least two years after the expiration date of the medicine.

2. The destruction of special-controlled medicines must be carried out strictly according to the prescribed procedures and in compliance with the law.

Chapter X

QUALITY STANDARDS FOR MEDICINES AND TESTING OF MEDICINES

AND THE TESTING OF DRUGS

Article 66. Quality Standards for Medicines

1. Vietnam's quality standards for medicines include national standards and enterprise standards.

2. National standards on the quality of medicines and testing methods are stipulated in the Vietnamese Pharmacopoeia.

Enterprise standards are established and published by the pharmaceutical production enterprises and must not be lower than the national standards on the quality of medicines.

3. The Government shall prescribe the issuance of the Vietnamese Pharmacopoeia, the application of foreign pharmacopoeias, and international pharmacopoeias in Vietnam.

Article 67. Testing of Medicines

1. Medicine testing must be conducted strictly in accordance with the quality standards registered by the production establishment. In cases where alternative testing methods are applied that differ from those registered, such methods must be approved by the Ministry of Health.

2. In cases where there is doubt about the composition or quality of the medicine, state testing establishments for medicines may apply different methods from those registered in the standards to conduct tests and issue test results on the quality of the medicine.

3. The Minister of Health shall specify the procedures and steps for sampling, retaining samples, and the content of quality testing of medicines.

Article 68. Testing Establishments for Medicines

Testing establishments for medicines include state testing establishments for medicines, enterprises providing testing services for medicines, and testing laboratories of medicine business establishments.

Article 69. State Testing Establishments for Medicines

1. State testing establishments for medicines assist drug management agencies in determining the quality of medicines.

2. State testing establishments for medicines have the rights and obligations as prescribed for enterprises providing testing services for medicines under Articles 33 and 34 of this Law.

3. The Government shall prescribe the organizational system and operation of state testing establishments for medicines.

Article 70. Resolution of Complaints Regarding Quality Test Conclusions

1. Medicine business establishments have the right to complain about the quality test conclusions issued by drug management agencies.

2. The Government shall prescribe the procedures, steps, and authorities responsible for resolving complaints regarding quality test conclusions.

Chapter XII

IMPLEMENTING PROVISIONS

Article 71. Transitional Provisions

Organizations and individuals who have been issued a Certificate of Qualification for Pharmaceutical Practice before this Law comes into effect and still have remaining validity periods shall not need to reapply for permission.

Article 72. Effective Date

This Law takes effect from October 1, 2005.

All previous provisions contrary to this Law are hereby abolished.

Article 73. Detailed Regulations and Guidance on Implementation

The Government shall promulgate detailed regulations and provide guidance on the implementation of this Law.

This Law was adopted by the National Assembly of the Socialist Republic of Vietnam, the eleventh session, seventh meeting, on June 14, 2005.