Law 44/2024/QH15 Amending and Supplementing a Number of Articles of the Law on Pharmacy

LAW

AMENDING AND SUPPLEMENTING A NUMBER OF ARTICLES OF THE LAW ON PHARMACY

Pursuant to the Constitution of the Socialist Republic of Vietnam;

The National Assembly promulgates the Law on Amending and Supplementing a Number of Articles of the Law No. 105/2016/QH13 on Pharmacy, which was amended and supplemented by the Law No. 28/2018/QH14.

Article 1. Amending and supplementing a number of articles of the Law on Pharmacy

1. To amend and supplement a number of clauses of Article 2 as follows:

a) To amend and supplement Clause 5 as follows:

“5. Medicinal materials (including traditional medicament) means drug materials which are derived from plant, animal, mineral or fungal origin and satisfy drug manufacture standards.

b) To amend and supplement Clauses 8, 9 and 10 as follows:

“8. Traditional drug means a drug composed of one or several medicinal materials which are blended according to traditional medicine theories or folk experiences, and are processed or prepared according to traditional medicine methods with a traditional or modern form.

9. Traditional medicament means medicinal materials preliminarily prepared, processed according to traditional medicine theories or folk experiences to manufacture or prepare a traditional drug.

10. Biological product (also called bio-drug) means a drug manufactured by a bio-technology or bio-process from a polymeric substance or mixture of polymeric substances of biological origin, including also microorganism, human blood and plasma derivatives.

Biological products do not include in vitro diagnostic biological products, antibiotics and low-molecular-weight substances of biological origin which can be isolated as pure substances.”;

c) To amend and supplement Clause 17, 18 and 19 as follows:

“17. Habit-forming drug means a drug containing pharmaceutical ingredients with neural stimulation or inhibition effects which can easily cause addiction to users, and included in the list of habit-forming drugs promulgated by the Minister of Health, except for combination drug containing a habit-forming pharmaceutical ingredient defined in Clause 20 of this Article.

18. Psychotropic drug means a drug containing pharmaceutical ingredients with neural stimulation or inhibition effects or causing hallucination, having the potential to induce a state of addiction when used consistently, and included in the list of psychotropic drugs issued by the Minister of Health, except for combination drug containing a psychotropic pharmaceutical ingredient defined in Clause 21 of this Article.

19. Pre-substance drug means a drug containing a pre-substance included in the list of pre-substances used as drugs issued by the Minister of Health, except for combination drug containing a pre-substance defined in Clause 22 of this Article.”;

d) To amend and supplement Clause 27 as follows:

“27. Non-prescription drug mean a drug that can be dispensed, retailed and used without a prescription, is determined according to principles and criteria issued by the Minister of Health, and is included in the list of non-prescription drugs promulgated by the Minister of Health.”;

dd) To amend and supplement Clause 37 as follows:

“37. Good practices means a set of principles and standards on the manufacture, preservation, testing, wholesale or retail of drugs or drug materials; prescription of drugs, clinical trial of drugs; cultivation and harvest of medicinal materials, and other sets of principles and standards promulgated or recognized by the Minister of Health for application.”;

e) To add Clauses 44, 45, 46, 47, 48, 49 and 50 after Clause 43 as follows:

“44. Tentative wholesale price means the maximum wholesale price set by the drug importer or the drug manufacturer before the wholesale distribution of the first lot of drug to the market, and no drug trading establishment is permitted to engage in wholesale transactions of drug at a price higher than such price.

45. Announcement of tentative wholesale price means that a drug importer or a drug manufacturer sends a notice on tentative wholesale price to the Ministry of Health before the distribution of the first lot of drug to the market for publication on the Ministry of Health's portal.

46. Re-announcement of tentative wholesale price means that a drug importer or a drug manufacturer sends a notice on tentative wholesale price to the Ministry of Health upon change in the announced tentative wholesale price for publication on the Ministry of Health's portal.

47. Similar drugs means drugs with the same pharmaceutical ingredient, medicinal materials, formulation and technical criteria.

48. Pharmacy chain means a system of pharmacies established by a pharmacy chain operator, which operates under a unified quality management system and under the same trade name.

49. Substandard drug material means a drug material that do not meet the quality standards registered or announced with the competent state agency.

50. High-tech drug means a drug on the List of hi-tech products approved by the Prime Minister or a drug manufactured and prepared using high technologies on the List of high technologies approved by the Prime Minister.”.

2. To amend and supplement Clause 3 Article 4 as follows:

“3. Ministries and ministerial-level agencies shall, within the ambit of their tasks and powers, perform the state management of pharmacy, manage substances used as drugs but banned from use under their management and coordinate with the Ministry of Health in performing the state management of pharmacy in accordance with the Government’s regulations.”.

3. To amend and supplement a number of points and clauses of Article 6 as follows:

a) To amend and supplement Clause 2 as follows:

“2. Conducting pharmaceutical business outside the pharmaceutical business place stated in the certificate of eligibility for pharmaceutical business or or permitted by a competent state agency, except for buying and selling activities by e-commerce method.”;

b) To amend and supplement Point i Clause 5 as follows:

“i) Wholesaling a prescription drug at a price higher than the announced or re-announced tentative wholesale price; wholesaling or retailing a drug at a price higher than the listed price.”;

c) To amend and supplement Clause 8 as follows:

“8. Practicing in the working positions prescribed in Article 11 of this Law without a pharmacy practice certificate or outside the professional scope stated in the pharmacy practice certificate, or practicing during the period of being deprived of the right to use a pharmacy practice certificate.”;

d) To add Clauses 17, 18 and 19 after Clause 16 as follows:

“17. Retailing by e-commerce method for the following drugs:

a) Prescription drugs, except for cases of medical isolation application when a class-A infectious disease has been declared as an epidemic in accordance with the law on prevention and control of infectious diseases;

b) Drugs under special control;

c) Drugs on the list of drugs restricted from retail.

18. Wholesaling by e-commerce method for the drugs under special control.

19. Trading in drugs and drug materials by e-commerce method through means other than e-commerce trading floors, e-commerce applications, and e-commerce websites with the function of online order.”.

4. To amend and supplement Article 7 as follows:

“Article 7. State policies on pharmacy

1. To ensure sufficient and prompt supply of quality drugs at reasonable prices to meet the people’s disease prevention and treatment needs, suit the structure of diseases and meet requirements of national defense and security, overcoming of consequences of incidents, natural disasters and catastrophes, epidemic prevention and control.

2. To ensure the rational, safe and effective use of drugs; to adopt the policies for development of clinical pharmacy and pharmacovigilance.

3. To adopt preferential and supportive policies aimed at developing the pharmaceutical industry into a spearhead industrial sector.

4. For drugs to be purchased with state budget funds and other lawful revenues of public medical establishments, the law on bidding shall be complied with, and the purchase of following drugs shall be prioritized:

a) Drugs that are researched and manufactured domestically using locally sourced raw materials, brand name specifics for which the technology has been transferred in Vietnam, generic drugs first manufactured in Vietnam, similar biological products that are first manufactured in Vietnam;

b) Drugs from medicinal materials and traditional drugs manufactured using locally sourced medicinal materials meeting the Good Agricultural and Collection Practices;

c) Drugs from medicinal materials and traditional drugs manufactured under national, ministerial or provincial scientific and technological tasks already tested and accepted.

d) Drugs on the list of national products approved by the Prime Minister.

5. To implement the administrative procedure-related prioritization as follows:

a) Regarding the order, procedures, and time for grant of certificates of free sale of drugs or drug materials in respect of new drugs; brand name specifics; rare drugs; vaccines; generic drugs first manufactured in Vietnam; similar biological products that are first manufactured in Vietnam; high-tech drugs; drugs that have been put for clinical trial in Vietnam; drugs manufactured using medicinal material sources meeting the Good Agricultural and Collection Practices; drugs and drug materials manufactured under national scientific and technological tasks already tested and accepted; drugs for national defense and security, overcoming of consequences of incidents, natural disasters or catastrophes, and epidemic prevention and control;

b) Regarding the criteria, order, procedures and time for grant of import licenses in respect of new drugs; rare drugs; vaccines that have been prequalified by the World Health Organization; high-tech drugs; drugs that have been put for clinical trial in Vietnam; drugs for national defense and security, overcoming of consequences of incidents, natural disasters or catastrophes, and epidemic prevention and control.

6. To apply preferential and support mechanisms from the National Technology Innovation Foundation, the National Foundation for Science and Technology Development, the National Hi-tech Venture Investment Fund and other funds supporting the scientific and technological activities in the following cases:

a) Research, development, clinical trials, technology transfer, production and commercialization of drug materials, new drugs, vaccines, biological products, high-tech drugs, generic drugs first manufactured in Vietnam, traditional drugs in modern dosage forms, and drugs from medicinal materials manufactured under national or ministerial scientific and technological tasks;

b) Investment in establishing and developing clinical trial centers in new drug development, bioequivalence testing, and biosimilarity testing.

7. To combine investment from the state budget and other mobilized resources in the development of the industry of manufacture of vaccines, biological products, drugs from medicinal materials and traditional drugs, drugs manufactured using locally sourced medicinal materials, generic drugs first manufactured in Vietnam; culture, cultivation or production of medicinal materials; discovery, conservation and application of science and technology to the research and development of gene sources of precious, rare and endemic medicinal materials.

8. To support and facilitate the discovery, clinical trial, registration for circulation, registration for related intellectual property rights protection,  and inheritance of traditional drugs and drugs from medicinal materials manufactured under national, ministerial or provincial scientific and technological projects already tested and accepted; search, exploitation and use of new medicinal materials; export of cultured and cultivated medicinal materials; acclimatization of medicinal materials; rational exploitation of natural medicinal materials; research, survey and investigation into appropriate medicinal material species for culture and cultivation in localities; development of medicinal material culture and cultivation zones; modernization of the production of and adoption of trade promotion policies for export of drugs from medicinal materials and traditional drugs.

9. To keep secret information in the preparation and processing of and clinical trial data on traditional drugs; to provide reasonable incentives for those who donate precious traditional medicaments to the State; to facilitate the grant of practice certificates to persons whose folk remedies have been recognized by the Ministry of Health.

10. To encourage the development of drug supply systems toward professionalism, modernity and effectiveness, ensuring timely and sufficient supply of quality drugs to meet the people’s needs; to encourage drugstores and pharmacies to open around the clock.

To provide incentives and support for the development of drug suppliers and mobile drug retailers in areas with ethnic minority people, mountainous areas, on islands, in areas with difficult socio-economic conditions and areas with extremely difficult socio-economic conditions.

11. To mobilize medical establishments in the people’s armed forces, civil-military medical examination and treatment establishments to participate in the supply of drugs and culture and cultivation of medicinal materials in order to meet the disease prevention and treatment needs of people in areas with ethnic minority people, mountainous areas, on islands, in areas with difficult socio-economic conditions and areas with extremely difficult socio-economic conditions.

12. To adopt the policies to raise the quality of human resources in the pharmacy sector, support the training of high-quality human resources in research, development, receipt of technology transfer, manufacturing and testing of new drugs, brand name specifics, high-tech drugs, drugs made from medicinal materials and traditional drugs.

13. To adopt the policies to maintain and reduce prices for new drugs, brand name specifics, high-tech drugs, vaccines and rare drugs for which the manufacturing technology are transferred in Vietnam.

14. To adopt the policies to control the number of certificates of free sale of drugs with the same pharmaceutical ingredient(s) or medicinal material(s) in conformity with socio-economic conditions in each period.

15. To prioritize investment in developing information technology infrastructure and implementing digital transformation in pharmacy activities.

16. The Government shall detail this Article.”.

5. To amend and supplement Article 8 as follows:

“Article 8. Investment incentive and support policies in the development of pharmaceutical industry

1. To implement investment incentive and support policies for investment projects in the pharmacy sector in accordance with the law on investment.

2. Newly established investment projects (including the expansion of such newly established projects) in the development of the pharmaceutical industry, having a total investment capital of at least VND 3,000 billion and a minimum of VND 1,000 billion disbursed within 03 years from the date of issuance of the investment registration certificate or the date of approval of the investment policy, shall be eligible for special investment incentives and support under the same terms as the entities specified at Point a, Clause 2, Article 20 of the Law on Investment, including:

a) Research to develop technology, manufacture or transfer technology to manufacture drugs from medicinal materials, traditional drugs using locally sourced medicinal materials, pharmaceutical ingredients, new drugs, brand name specifics, rare drugs, generic drugs first manufactured in Vietnam, high-tech drugs, vaccines, biological products;

b) Cultivation of medicinal materials in areas with difficult socio-economic conditions or areas with extremely difficult socio-economic conditions;

c) Research for conservation and development of gene sources of precious, rare and endemic medicinal materials; develop new varieties from high-value gene sources of medicinal materials.

3. The Government shall detail this Article.”.

6. To amend and supplement a number of points and clauses of Article 10 as follows:

a) To amend and supplement Point a Clause 3 as follows:

“a) Assume the prime responsibility for, and coordinate with the Ministry of Health and Ministry of Science and Technology in, formulating legal documents for the purpose of managing and organizing the implementation of selection and creation of varieties and breeds, culture, cultivation and harvest of medicinal materials; widely applying techniques of culture and cultivation of, and prevention and control of harmful pests and diseases on, medicinal plants and animals;”;

b) To amend and supplement Point a, Clause 6 as follows:

“a) Propose competent authorities to allocate, or allocate within its competence, funding to implement plans and programs for pharmaceutical industry development in accordance with the Law on State Budget;”;

c) To amend and supplement Clause 7 as follows:

“7. The Ministry of Science and Technology shall:

a) Propose competent authorities to allocate or allocate according to its competence annual state budget funds for scientific and technological activities for research and application of research results in the manufacture of drugs in accordance with law regulations, especially those 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, organizing research, conservation and sustainable use of gene sources of precious, rare and endemic medicinal materials; research of selection and creation of varieties and breeds, culture and cultivation of, and prevention and control of harmful pests and diseases on, medicinal plants and animals, and harvest of medicinal materials;

c) Assume the prime responsibility for, and coordinate with the Ministry of Health in, developing mechanism and policies on protection of intellectual property rights of traditional drugs;

d) Assume the prime responsibility for, and coordinate with the relevant ministries and ministerial-level agencies in, developing mechanism and policies on application of science and technology for the purpose of pharmaco-chemical industry development.”;

d) To amend and supplement Point b Clause 8 as follows:

“b) Allocate land areas for building pharmaceutical factories and industrial zones, projects on development of medicinal material sources and medicinal material culture and cultivation zones in accordance with the land law.”.

7. To amend and supplement Point b Clause 1 Article 12 as follows:

“b) A person who has had his/her pharmacy practice certificate revoked under Article 28 of this Law.

Such certificate may only be re-granted after 24 months since the date of revocation for cases subject to revocation defined in Clauses 4, 6, 10 and 11 Article 28 of this Law.”.

8. To add Article 17a after Article 17 as follows:

“Article 17a. Conditions on persons responsible for professional pharmacy activities at pharmacy chain operators, pharmacies in pharmacy chains

1. A person responsible for professional pharmacy activities of a pharmacy chain operator must possess a professional degree specified at Point a, Clause 1, Article 13 of this Law and have practiced for 2 years at an appropriate pharmacy establishment.

2. A person responsible for professional pharmacy activities at a pharmacy in the pharmacy chain must meet the conditions defined in Clause 1, Article 18 of this Law .”.

9. To amend and supplement Clause 7 Article 24 as follows:

“7. A judicial record card of the applicant, except for cases where the judicial record database is updated and shared with the dossier-receiving agency in accordance with the Government’s regulations.

For a foreigner or an overseas Vietnamese, there must be a judicial record or document certifying that the applicant neither commits a crime nor faces a penal liability examination nor a ban from practice or performance of a job related to pharmacy activities under a court’s judgment or decision issued by a competent foreign agency.”.

10. To amend and supplement Clause 8 Article 28 as follows:

“8. The holder of pharmacy practice certificate has not practicing any activity within the scope of professional activities stated in the certificate for 24 consecutive months.”.

11. To amend and supplement a number of clauses of Article 31 as follows:

a) To amend and supplement Clause 3 as follows:

“3. To be responsible for professional activities of only one pharmaceutical business establishments and at only one place of pharmaceutical business, except for cases defined in Clause 3a of this Article.”;

b) To add Clause 3a after Clause 3 as follows:

“3a. A person responsible for professional pharmacy activities at a pharmacy chain operator must take the general responsibility for professional pharmacy for activities of the pharmacy chain operator.”.

12. To amend and supplement a number of points and clauses of Article 32 as follows:

a) To amend and supplement Point a Clause 1 as follows:

“a) Trading in drugs or drug materials, also including trading in drugs or drug materials by e-commerce method on e-commerce trading floors, e-commerce applications, and e-commerce websites with the function of online order;”;

b) To add Point i after Point h Clause 2 as follows:

“i) Pharmacy chain operators.”.

13. To add Point h after Point g Clause 1 Article 33 as follows:

“h) A pharmacy chain operator must meet the conditions specified at Point c of this Clause, have 02 affiliated pharmacies or more for which a certificate of eligibility for pharmaceutical business has been granted and have a unified quality management system to apply to pharmacies in the chain.”.

14. To amend and supplement Point d Clause 1 Article 35 as follows:

“d) Medical establishments in the people’s armed forces, civil-military medical examination and treatment establishments engaged in the supply of drugs in areas with ethnic minority people, mountainous areas, on islands, in areas with difficult socio-economic conditions and areas with extremely difficult socio-economic conditions.”.

15. To amend and supplement Clause 3 Article 36 as follows:

 “3. A certificate of eligibility for pharmaceutical business shall be modified in the following cases:

a) There is a change in the name, business address;

b) There is a change in business scope of the pharmaceutical business establishment, which does not result in a change in the pharmaceutical business conditions;

c) There is a change in the information about the person responsible for professional pharmacy activities stated in the certificate of eligibility for pharmaceutical business, except for cases of rotation of persons responsible for professional pharmacy activities among the pharmacies in the pharmacy chain.”.

16. To amend and supplement Clause 1 Article 37 as follows:

“1. The Minister of Health may grant, re-grant, modify and revoke certificates of eligibility for pharmaceutical business of business establishments specified at Points a, b, c, e, g, h and i, Clause 2, Article 32 of this Law.”.

17. To add a number of points to Article 38 as follows:

a) To add Point dd after Point d, Clause 1 as follows:

“dd) List of pharmacies in the pharmacy chain that have been granted a certificate of eligibility for pharmaceutical business until the time of dossier submission, for pharmacy chain operators.”;

b) To add Point dd after Point d, Clause 2 as follows:

“dd) List of pharmacies in the pharmacy chain that have been granted a certificate of eligibility for pharmaceutical business until the time of dossier submission, for pharmacy chain operators.”.

18. To amend and supplement a number of points and clauses of Article 42 as follows:

a) To amend and supplement Point dd and to add Point e after Point dd Clause 1 as follows:

“dd) To organize mobile drug retailers in areas with ethnic minority people, mountainous areas, on islands, in areas with difficult socio-economic conditions and areas with extremely difficult socio-economic in accordance with the Government’s regulations;

e) To sell prescription drugs from the date the Ministry of Health receives the dossier of announcement or re-announcement of tentative wholesale price of drug manufacturers or drug importers”;

b) To add Point q after Point p Clause 2 as follows:

“q) To take responsibility before law for the accuracy, legality and honesty of the records and documents provided to the competent agency.”;

c) To add Clause 4 after Clause 3 as follows:

“4. In addition to the rights and responsibilities specified in Clauses 1, 2 and 3 of this Article, when conducting business via e-commerce, a pharmaceutical business establishment has the following rights and responsibilities:

a) To comply with the law regulations on e-transactions, e-commerce, advertising, protection of consumer rights and other relevant law regulations;

b) To ensure the confidentiality of the purchaser’s information in accordance with law regulations;

c) To fully post the information about the certificate of eligibility for pharmaceutical business, pharmacy practice certificate of person responsible for professional pharmacy activities of the establishment, information on the drugs approved in accordance with the Government’s regulations;

d) To notify the competent agency of pharmaceutical business via e-commerce in accordance with the Minister of Health’s regulations;

dd) Drug retailing establishments must provide online consultation and guidance on the use of drugs to purchasers and must arrange for the delivery of drugs to purchasers in accordance with the Minister of Health’s regulations;

e) To retail non-prescription drugs provided that such drugs are neither subject to special control nor included in the the list of drugs restricted from retail.

To retail prescription drugs in accordance with the Minister of Health’s regulations in cases of medical isolation application when a class-A infectious disease has been declared as an epidemic in accordance with the law on prevention and control of infectious diseases;

g) To wholesale drugs and drug materials other than drugs under special control;

h) To comply with other regulations of the Government on wholesale of drugs and drug materials via e-commerce.”.

19. To amend and supplement a number of points and clauses of Article 43 as follows:

a) To amend and supplement Point e Clause 1 as follows:

“e) To wholesale its manufactured drugs or drug materials to medical examination and treatment establishments, vaccination establishments, and other medical establishments; drug addiction treatment establishments; state-owned drug and drug material testing establishments; science and technology organizations, and training institutions engaged in pharmaceutical research and teaching; pharmaceutical business establishments as prescribed in Clause 2, Article 32 of this Law; establishments that have obtained an investment registration certificate for drug manufacturing but have not yet been granted a certificate of eligibility for pharmaceutical business for the activities of trial production and evaluation of the drug manufacturing process;”;

b) To add Point e after Point dd, Clause 2 as follows:

“e) To implement the announcement and re-announcement of tentative wholesale price in accordance with this Law.”.

20. To amend and supplement a number of points and clauses of Article 44 as follows:

a) To amend and supplement Point a Clause 1 as follows:

“a) The rights specified in Points a, b, c, d and e, Clause 1, Article 42 of this Law;”;

b) To amend and supplement Point d Clause 1 as follows:

“d) To wholesale its imported drugs or drug materials to medical examination and treatment establishments, vaccination establishments, and other medical establishments; drug addiction treatment establishments; state-owned drug and drug material testing establishments; science and technology organizations, and training institutions engaged in pharmaceutical research and teaching; pharmaceutical business establishments as prescribed in Clause 2, Article 32 of this Law; establishments that have obtained an investment registration certificate for drug manufacturing but have not yet been granted a certificate of eligibility for pharmaceutical business for the activities of trial production and evaluation of the drug manufacturing process;”;

c) To add Point c after Point b, Clause 2 as follows:

“c) To implement the announcement and re-announcement of tentative wholesale price in accordance with this Law.”.

21. To amend and supplement a number of points and clauses of Article 46 as follows:

a) To amend and supplement Point b Clause 1 as follows:

“b) To wholesale drugs or drug materials to medical examination and treatment establishments, vaccination establishments, and other medical establishments; drug addiction treatment establishments; state-owned drug and drug material testing establishments; science and technology organizations, and training institutions engaged in pharmaceutical research and teaching; pharmaceutical business establishments as prescribed in Clause 2, Article 32 of this Law; establishments that have obtained an investment registration certificate for drug manufacturing but have not yet been granted a certificate of eligibility for pharmaceutical business for the activities of trial production and evaluation of the drug manufacturing process;”;

b) To add Point c after Point b, Clause 2 as follows:

“c) Declare wholesale prices of drugs in accordance with Clause 5 Article 107 of this Law.”.

22. To amend and supplement a number of points and clauses of Article 47 as follows:

a) To amend and supplement Point b Clause 1 as follows:

“b) To purchase drug materials for preparation of prescription drugs and sell such drugs at the store or to exercise the right defined at Point b Clause 3 Article 47a of this Law. A person responsible for professional pharmacy activities at the drugstore shall directly manage the preparation of drugs at the pharmacy;”;

b) To add Point d after Point c, Clause 2 as follows:

“d) Declare retail prices of drugs in accordance with Clause 5 Article 107 of this Law.”.

23. To add Article 47a after Article 47 as follows:

“Article 47a. Rights and responsibilities of pharmacy chain operators, pharmacies in pharmacy chains

1. A pharmacy chain operator has the following rights:

a) Rights defined in Clause 1 Article 42 of this Law;

b) To purchase drug materials to transfer them to the pharmacies in the chain in order that such pharmacies make preparation of prescription drugs and sell the drugs in the preparing ones;

c) To purchase drugs to transfer them to pharmacies in the chain for retail sale, except for vaccines. The purchase of drugs under special control and drugs on the list of drugs restricted from retail must comply with Article 34 of this Law;

d) The circulation of drugs between the drug storage warehouses of the pharmacy chain operator and its affiliated pharmacies, and among the pharmacies in the chain, excluding drugs prepared according to prescriptions. The circulation of drugs shall be coordinated by the persons responsible for professional pharmacy activities at the pharmacy chain operator;

dd) To rotate persons responsible for professional pharmacy activities among the pharmacies in the pharmacy chain.

2. A pharmacy chain operator has the following responsibilities:

a) Responsibilities specified at Points a, b, c, d, dd, h, k, l, m, n and q, Clause 2, Article 42 of this Law;

b) To establish a quality management system for the pharmacy chain, which includes the organizational structure, procedures, human resources, documentation, information system, governance system, technical infrastructure, and all systematic activities, complying with good practices relevant to the scope of business;

c) To manage all activities related to the supply, distribution, and storage of drugs and drug materials, and customer-related data at all pharmacies in the chain by using unified procedures;

d) To supply all drugs and drug materials to the pharmacies in the chain;

dd) To take full responsibility for the operations of the pharmacies in the chain;

e) To report to the Ministry of Health and the provincial-level Health Departments of the localities where pharmacies in the chain operate, and fulfill all obligations defined by law regulations in the event that the pharmacy chain operator suspends its operations for a period of six months or more, or ceases its operations;

g) To comply with the Minister of Health's regulations on notifying and updating the competent agencies with the list of pharmacies in the pharmacy chain; the list of persons who have a pharmacy practice certificate and are practicing at the pharmacy chain operator and at pharmacies in the pharmacy chain; and the rotation of persons responsible for professional pharmacy activities among the pharmacies in the pharmacy chain;

h) To report on an annual basis and at request by the a competent state management agency in charge of pharmacy on the operations of the pharmacy chain operator and the pharmacies in the pharmacy chain; and to notify the Ministry of Health within 3 working days from the date a pharmacy in the pharmacy chain is administratively sanctioned for violations in the field of pharmacy.

3. A pharmacy in a pharmacy chain has the following rights:

a) Rights specified at Points a, d and dd, Clause 1, Article 47 of this Law;

b) To receive drug materials from the pharmacy chain operator for reparation of drugs under prescriptions and sell such drugs in the pharmacy. The person responsible for professional pharmacy activities at the pharmacy shall directly manage the preparation of drugs at the pharmacy;

c) To receive drugs from the pharmacy chain operator for retail, except for vaccines; the purchase of drugs under special control and drugs on the list of drugs restricted from retail must comply with Article 34 of this Law.

4. A pharmacy in a pharmacy chain has the following responsibilities:

a) Responsibilities specified at Points a, b, c, d, dd, e, h, k, l, m, n, o, p and q , Clause 2, Article 42; Points b, c and d, Clause 2, Article 47; Clause 2, Article 81 of this Law;

b) To conduct exclusively the business of drugs supplied by the pharmacy chain operator;

c) To comply with the quality management system established by the pharmacy chain operator;

d) To suspend its operations in the event that the pharmacy chain operator suspends its operations for a period of six months or more;

dd) To terminate its operations when the pharmacy chain operator ceases its operations.”.

24. To add Point c after Point b Clause 2 Article 48 as follows:

“c) Declare retail prices of drugs in accordance with Clause 5 Article 107 of this Law.”.

25. To add Point c after Point b Clause 2 Article 49 as follows:

“c) Declare retail prices of drugs in accordance with Clause 5 Article 107 of this Law.”.

26. To add Point c after Point b Clause 2 Article 50 as follows:

“c) Declare retail prices of drugs from medicinal materials and traditional drugs in accordance with Clause 5 Article 107 of this Law.”.

27. To add Article 53a after Article 53 in Chapter IV as follows:

“Article 53a. Rights and responsibilities of foreign-invested pharmaceutical business establishments

1. Foreign-invested pharmaceutical business establishments defined at Point a, b, e, g and h, Clause 2, Article 32 of this Law have the following rights:

b) Rights defined at Points b, c and d Clause 1 Article 42 of this Law;

b) Rights corresponding to the type of pharmaceutical business establishment specified at Points b, c, d, dd and g Clause 1 Article 43, Points b, c and dd Clause 1 Article 44, Points b, c and d Clause 1 Article 51, Points b, c and d Clause 1 Article 52, Points b, c, d and dd Clause 1 Article 53 of this Law.

2. A foreign-invested establishment manufacturing drugs or drug materials has the rights specified in Clause 1 of this Article and the following rights:

a) To engage in the wholesale, distribution, and transportation of drugs or drug materials produced, manufactured under contract, or received technology transfer in Vietnam by itself to medical examination and treatment establishments, vaccination establishments, and other medical establishments; drug addiction treatment establishments; state-owned drug and drug material testing establishments; science and technology organizations, and training institutions engaged in pharmaceutical research and teaching; pharmaceutical business establishments as prescribed in Clause 2, Article 32 of this Law; establishments that have obtained an investment registration certificate for drug manufacturing but have not yet been granted a certificate of eligibility for pharmaceutical business for the activities of trial production and evaluation of the drug manufacturing process.

An establishment manufacturing drugs may sell prescription drugs from the date the Ministry of Health receives its dossier of announcement or re-announcement of tentative wholesale price;

b) To deliver, receive and transport drugs under programs of assistance, aid or humanitarian aid, and epidemic prevention and control to medical establishments receiving such support.

3. A foreign-invested establishment importing drugs or drug materials has the rights specified in Clause 1 of this Article and the following rights:

a) To wholesale drugs or drug materials imported by itself to establishments wholesaling drugs or drug materials. An establishment importing drugs may sell prescription drugs from the date the Ministry of Health receives its dossier of announcement or re-announcement of tentative wholesale price;

b) To repurchase drugs or drug materials for which the establishment conducts technology transfer in Vietnam by itself; sell drugs or drug materials for which the establishment by itself places an order for manufacturing or conducts technology transfer in Vietnam to establishments wholesaling drugs or drug materials;

c) To import drug materials within the scope stated on its certificate of eligibility for pharmaceutical business to supply drug manufacturing establishments with drugs for which the establishment by itself places an order for manufacturing or conducts technology transfer in Vietnam under a manufacturing agreement or technology transfer contract;

d) To deliver, receive and transport drugs or drug materials imported by the establishment, or drugs or drug materials for which the establishment by itself places an order for manufacturing or conducts technology transfer in Vietnam, from its storehouse for preservation of drugs or drug materials to establishments wholesaling drugs or drug materials;

dd) To deliver and transport drugs under programs of assistance, aid or humanitarian aid, and epidemic prevention and control to medical establishments receiving such support;

e) To transport drug materials imported by the establishment from its storehouse for preservation of drug materials to the drug manufacturing establishments of which the establishment by itself places an order for manufacturing or conducts technology transfer in Vietnam under a manufacturing agreement or technology transfer contract; and to transport drugs used in clinical trials sponsored and imported by the establishment to establishments conducting clinical trial of drugs.

4. Pharmaceutical business establishments defined at Points a, b, e, g and h Clause 2 Article 32 with foreign investment shall take responsibilities corresponding to each type of pharmaceutical business establishment provided in Clause 2 Article 42, Clause 2 Article 43, Clause 2 Article 44, Clause 2 Article 51, Clause 2 Article 52, Clause 2 Article 53 of this Law, and are not permitted to engage in activities directly related to the distribution of drugs and drug materials, including:

a) To sell, deliver, receive, transport drugs or drug materials, except for cases stipulated in Clause 2 and Clause 3 of this Article;

b) To accept the preservation of drugs or drug materials that are not imported, manufactured, ordered for manufacturing or manufactured through technology transfer in Vietnam by the establishments themselves;

c) To receive orders and receive payments for drugs or drug materials from medical examination and treatment establishments, retail establishments, individuals, or organizations other than establishments wholesaling drugs or drug materials, except for cases stipulated in Clause 2 of this Article;

d) To determine and impose the selling price for drugs or drug materials distributed by pharmaceutical business establishments, except for cases complying regulations on drug price management under this Law;

dd) To decide the distribution strategy and business policies for drugs or drug materials distributed by other pharmaceutical business establishments;

e) To formulate supply plans for drugs or drug materials for medical examination and treatment establishments in Vietnam;

g) To provide financial support in any form to organizations or individuals directly purchasing drugs or drug materials from the establishment for the purpose of manipulating the distribution of imported drugs or drug materials.

5. Foreign-invested pharmaceutical business establishments must not conduct retail of drugs, wholesale of drugs and drug materials, except for cases defined in Clause 2 and Clause 3 of this Article.”.

28. To amend and supplement Point b Clause 1 Article 54 as follows:

“b) Imported drugs as prescribed in Clause 2 and Clause 5a Article 60 of this Law;”.

29. To amend and supplement Points b and c Clause 2 Article 55 as follows:

“b) Drugs which already have certificates of free sale but then see changes or supplements of their pharmaceutical ingredients or medicinal materials; content, concentration or amount of pharmaceutical ingredients or medicinal materials per dose; form of preparation; or change of their manufacturer, except for change or supplements of packaging establishment or manufacturing workshop or location;

c) Drug materials which already have certificates of free sale but then see changes or supplements of their manufacturer, except for changes or supplements of packaging establishment or manufacturing workshop or location.”.

30. To amend and supplement Article 56 as follows:

“Article 56. Competence, dossiers, procedures and time limits for grant, extension and modification and supplementation of the content of a certificate of free sale of drugs or drug materials

1. The Ministry of Health shall grant, extend or modify and supplement the content of certificates of free sale of drugs or drug materials on the basis of dossier appraisal and advice from the advisory council for grant of certificates of free sale of drugs or drug materials, except for cases defined at Point b Clause 9 of this Article.

2. The Ministry of Health shall publish the following information on its portal:

a) Information about the grant, extension and modification and supplementation of certificates of free sale of drugs or drug materials;

b) Case specified at Point b Clause 8 of this Article;

c) Non-prescription drugs after certificates of free sale of drugs are granted.

3. A dossier of application for a certificate of free sale of drugs or drug materials must comprise:

a) Administrative documents, including an application for a certificate of free sale of drugs or drug materials; the Vietnam-based representative office’s establishment license which remains valid, for foreign establishments trading in drugs and drug materials, or the certificate of eligibility for pharmaceutical business, for Vietnamese establishments trading in drugs and drug materials; the certificate of pharmaceutical products, for imported drugs, which remains valid; sample labels of drugs or drug materials; information on drugs and other documents on trading and circulation of drugs or drug materials;

In case of meeting the need for prevention and treatment of a class-A infectious disease already declared as an epidemic in accordance with the law on prevention and control of infectious diseases, other documents granted by a competent agency may be used to replace the certificate of pharmaceutical products, with the contents confirming that the drug is allowed to be circulated and used in the host country and the complete information on the name, address of the manufacturing establishment and licensing conditions;

b) Technical documents proving that drugs or drug materials satisfy the requirements prescribed in Clause 4, Article 54 of this Law; for new drugs, reference biological products, and vaccines, clinical trial documents proving their safety and efficacy are also required; for similar biological products, documents proving the similarity in their quality, safety and efficacy against a reference biological products are also required; for drugs subject to bioequivalence trial, a report on their bioequivalence study data is also required; in case the registering establishment requests to apply the form of referring to the results of drug registration dossier appraisal, it must submit additionally documents on the assessment results of a Stringent Regulatory Authority (SRA) or a pharmacy management agency recognized by the Ministry of Health based on the classification of the World Health Organization.

With respect to a domestically manufactured new drug (except for vaccines) indicated for prevention and treatment of a class-A infectious disease already declared as an epidemic in accordance with the law on prevention and control of infectious diseases that has the same active ingredient, formulation, route of administration and indications as a drug for which a certificate of free sale has been granted or a drug licensed for use in emergency cases or a drug for which a certificate of free sale with conditions has been granted by a Stringent Regulatory Authority (SRA) or a pharmacy management agency recognized by the Ministry of Health based on the classification of the World Health Organization, clinical trial documents are not required in the dossier of application for a certificate of free sale of drugs;

c) Sample labels of drugs or drug materials sold in the host country or a reference country, for imported drugs.

4. A dossier of request for extension of a certificate of free sale of drugs or drug materials must comprise:

a) An application for extension of a certificate of free sale of drugs or drug materials;

b) The certificate of pharmaceutical products, for imported drugs, which remains valid;

c) A report of the safety and efficacy of drugs during circulation.

5. A dossier of request for modification and supplementation of the content of a certificate of free sale of drugs or drug materials must comprise:

a) An application for modification and supplementation of the content of a certificate of free sale of drugs or drug materials;

b) Technical documents, for the modified and supplemented contents.

6. The time limit for grant, extension or modification and supplementation of the content of a certificate of free sale of drugs or drug materials is:

a) Twelve months from the date of receipt of a complete dossier of application defined in Clause 3 of this Article, except for cases defined at Points b and e of this Clause;

b) Nine months from the date of receipt of a complete dossier of application defined in Clause 3 of this Article, for cases requesting to apply the form of referring to the appraisal results;

c) Three months from the date of receipt of a complete dossier of application defined in Clause 4 of this Article;

d) Three months from the date of receipt of a complete dossier of application defined in Clause 5 of this Article, except for cases defined at Point dd of this Clause;

dd) Twenty days from the date of receipt of a complete dossier of application defined in Clause 5 of this Article, for cases where the modified and supplemented contents do not effect the drug's quality, safety and efficacy;

e) Fifteen days from the date of receipt of a complete dossier of application defined in Clause 3 of this Article, for a dossier of application for a certificate of free sale of a new drug indicated for prevention and treatment of a class-A infectious disease already declared as an epidemic in accordance with the law on prevention and control of infectious diseases that is granted a certificate of free sale or is licensed for use in emergency cases or is granted a certificate of free sale with conditions by a Stringent Regulatory Authority (SRA) or a pharmacy management agency recognized by the Ministry of Health based on the classification of the World Health Organization.

7. The Ministry of Health shall carry out the grant, extension and modification and supplementation of the contents of certificates of free sale of drugs or drug materials within the time limit defined in Clause 6 of this Article; in cases of refusal to do so, it must send a written reply, clearly stating the reason.

In cases where a drug has not been marketed for 5 years from the date its certificate of free sale takes effect, such certificate of free sale shall not be renewed, except for rare drugs and drugs for which there are no more than 3 products from 3 different manufacturers with the same pharmaceutical ingredient(s), medicinal material(s), formulation, content or concentration of pharmaceutical ingredient(s), or the mass of medicinal material(s) per dose and certificates of free sale have been granted and remain valid. 

8. The validity duration of a certificate of free sale of drugs or drug materials is defined as follows:

a) The validity duration of a certificate of free sale of drugs or drug materials is 5 years from the date of its grant or extension, except for the cases specified at Points b and c of this Clause;

b) For drugs whose safety and efficacy must be further monitored, the validity duration of a certificate of free sale is 3 years from the date of its grant or extension.

c) In case the certificate of free sale of drugs or drug materials has expired, but the Ministry of Health has received a dossier of request for renewal of such certificate in accordance with regulations, it shall continue to be used until it is renewed or until the Ministry of Health issues a written notice on refusal of renewal or a notice on suspension from use of certificate of free sale of drugs or drug materials upon detection of the drugs or drug materials likely to be unsafe to users or doubt about forged legal documents.

9. The Minister of Health shall prescribe in detail the dossier of application for grant, extension or modification and supplementation of the content of a certificate of free sale of drugs or drug materials defined in Clauses 3, 4 and 5 of this Article and specify the following contents:

a) Procedures for grant, extension and modification and supplementation of certificates of free sale of drugs or drug materials;

b) Cases where dossier appraisal and advice from the advisory council for grant of certificates of free sale of drugs or drug materials is not required for dossiers of application for grant, extension or modification and supplementation of the contents of certificates of free sale of drugs or drug materials, based on the assessment of risks related to quality, safety and efficacy of the drugs or drug materials;

c) Grant of certificates of free sale of drugs for new drugs indicated for prevention and treatment of class-A infectious diseases already declared as epidemics in accordance with the law on prevention and control of infectious diseases based on the recognition of licensing results of a Stringent Regulatory Authority (SRA) or a pharmacy management agency recognized by the Ministry of Health based on the classification of the World Health Organization without technical document appraisal and assessment of its satisfaction of good manufacture practices.”.

31. To amend and supplement Point b Clause 1 Article 59 as follows:

 “b) Imported drugs and drug materials prescribed in Clauses 1, 2, 3, 4 and 5a Article 60 of this Law;”.

32. To amend and supplement a number of points and clauses of Article 60 as follows:

a) To amend and supplement Points h and i, Clause 2 as follows:

“h) Drugs used for bioequivalence trial, bioavailability assessment, scientific research or display at exhibitions or fairs, or used as samples for registration or testing;

i) Drugs in other cases for non-commercial purpose, also including drugs imported by medical examination and treatment establishments to provide the specific treatment to their patients.”;

b) To amend and supplement Clause 3 as follows:

“3. Drug materials which do not have certificates of free sale in Vietnam may be imported in a quantity not exceeding that stated in their import permits in the following cases:

a) For use as samples for registration or testing, or for research or display at exhibitions or fairs;

b) For manufacture of drugs for export, semi-finished drugs for export, drugs for national defense and security, drugs for prevention and treatment of a class-A infectious disease already declared as an epidemic in accordance with the law on prevention and control of infectious diseases, or overcoming of consequences of incidents, natural disasters or catastrophes; manufacture or preparation to serve the treatment of medical examination and treatment establishments.”;

c) To add Clause 5a and Clause 5b after Clause 5 as follows:

“5a. Drugs which do not have certificates of free sale in Vietnam and are used for clinical trial of drugs may be imported without a import permit in a quantity and type according to the information published on the Ministry of Health’s portal based on the written explanation of research outline of the clinical trial already approved by the the Ministry of Health, except for drugs defined in Clause 4 of this Article.

5b. The Minister of Health shall consider and decide on the use of pharmaceutical ingredients and medicinal materials for manufacture of drugs for which certificates of free sale are granted that are indicated for prevention and treatment of a class-A infectious disease already declared as an epidemic in accordance with the law on prevention and control of infectious diseases, for pharmaceutical ingredients and medicinal materials permitted for import for other purposes.”;

d) To add Clause 6a after Clause 6 as follows:

“6a. The Ministry of Finance shall be responsible for periodically sharing information with the Ministry of Health on data on drugs under special control for which the customs clearance for import or export has been completed in accordance with the Government's regulations.”;

dd) To amend and supplement Clause 7 as follows:

“7. The Government shall define the following contents:

a) Criteria, dossier, procedures and time limit for grant and revocation of import or export permits for drugs and drug materials prescribed in Clauses 2, 3, 4 and 5 of this Article, and the list of drugs and drug materials banned from import or banned from manufacture;

b) Import of medicinal materials, adjuvants, capsules and primary packages of drugs.

c) The declaration form for drug import specified in Clause 5a and the dossier, procedures, and time limit for handling the change of material use purpose specified in Clause 5b of this Article;

d) The transfer of drugs specified at Point c, Clause 2 of this Article; the provision of drugs imported by medical examination and treatment establishments to serve their special treatment needs specified at Point i, Clause 2 of this Article to other medical examination and treatment establishments.”.

33. To add Clause 3 after Clause 2, Article 62 as follows:

“3. The Government shall detail the recall of drug materials and define the disposal of recalled drug materials.”.

34. To amend and supplement a number of points and clauses of Article 64 as follows:

a) To amend and supplement Points dd and e, Clause 1 as follows:

“dd) Send a report on the recall of drugs and its result to the Ministry of Health; and send it to the relevant provincial-level Department of Health issuing a decision on recall (if any);

e) Report on the voluntary recall of drugs to the Ministry of Health.”;

b) To amend and supplement Clause 2 as follows:

“2. Establishments wholesaling drugs or drug materials, drug retailing establishments, pharmacy chain operators shall:

a) Stop trading in, providing or dispensing the recalled drug;

b) Notify and organize the recall and receipt of the recalled drug;

c) Return the recalled drug to the drug supplier;

d) Pay expenses for the recall and disposal of the recalled drug, and pay compensations in accordance with law in case they are at fault.”;

c) To amend and supplement Points a and b, Clause 4 as follows:

“a) Decide on the recall of drugs and disposal of the recalled drugs nationwide, based on the level of the violation regarding the quality, safety and efficacy of the drugs; update information on the drugs involved in violations and disposal of such drugs on the Ministry of Health's portal and the pharmaceutical information system in the national health database;

b) Re-determine the levels of violations and request pharmaceutical business establishment to adjust the scope and time of recall in accordance with the re-determined levels of violations in accordance with Clause 2 and Clause 3, Article 63 of this Law within 24 hours from the time of receiving the reports on voluntary drug recall from the pharmaceutical business establishments;”;

d) To add Clause 4a after Clause 4 as follows:

“4a. Provincial-level Departments of Health have the following responsibilities:

a) Decide on the recall of drugs in accordance with Clause 2 Article 65 of this Law, based on the level of the violation regarding the quality, safety and efficacy of the drugs; update information on drugs involved in violations and disposal of such drugs on portals of provinces and centrally-run cities and the pharmaceutical information system in the national health database;

b) Issue notices on suspension of circulation and recall of drugs in their locality according to the Ministry of Health's drug recall decisions;

c) Inspect and supervise the organization and implementation of drug recall in their locality and handle violating establishments in accordance with law regulations.”.

35. To amend and supplement Article 65 as follows:

“Article 65. Competence to issue recall decisions, procedures for recall

1. The Ministry of Health shall decide the compulsory recall of a drug nationwide in the following cases:

a) Drug involved in level-1 violations;

b) Drug involved in level-2 or level-3 violations due to fault of the drug manufacturer or drug importer;

c) Drug recalled in two or more provinces or centrally-run cities.

2. A relevant provincial-level Department of Health shall decide to recall a drug in case of compulsory recall of the drug involved in level-2 or level-3 violations detected in the locality, and at the same time report on it to the Ministry of Health.

3. Such decision on drug recall shall be issued within 24 hours after the issuance of a conclusion that the drug shall be recalled and its violation level.

4. In case additional information is needed to determine the level of violation involving the drug, within 24 hours of receiving the report from the relevant provincial-level Department of Health or state-owned drug or drug material testing establishment, the Ministry of Health shall issue a written request for additional information.

5. The head of a drug registration establishment, a domestic drug-manufacturing establishment, an establishment importing or entrusted to import a drug shall decide the voluntary recall of the drug in and report on it to the Ministry of Health within 24 hours from the time of issuance of the Ministry of Health shall recall decision.

6. The Minister of Health shall stipulate in detail the making of a conclusion on a drug which shall be recalled, level of violation involving the drug, procedures for the recall, and handling of the recalled drug.”.

36. To amend and supplement Clause 2 Article 74 as follows:

“2. The Minister of Health shall prescribe in detail prescriptions and prescription of drugs, application of information technology in prescription of drugs, sale of prescription drugs and data connection with the pharmaceutical information system in the national health database.”.

37. To amend and supplement a number of points and clauses of Article 76 as follows:

 a) To amend and supplement Clause 1 as follows:

“1. Drug information aims to provide instructions on how to use drugs in a rational, safe and effective manner for medicine practitioners, pharmacy practitioners and drug users.”;

b) To amend and supplement Point a, Clause 5 as follows:

“a) Information for medicine practitioners and pharmacy practitioners, including drug name, ingredients, concentration, content, forms of preparation, indications, contraindications, dosage, route of administration, use on special users, warnings and safety, and other necessary information;”;

c) To add Point d after Point c, Clause 5 as follows:

“d) Drug information must not contain information or images not directly related to the drug or drug use.”;

d) To amend and supplement Point b Clause 6 as follows:

“b) Pharmaceutical business establishments, representative offices of foreign traders engaged in pharmaceutical business in Vietnam, and drug registration establishments shall provide drug information conforming to documents defined in Clause 3 of this Article for medicine practitioners, drug users and pharmacy practitioners.

Employees of pharmaceutical business establishments shall introduce drugs to medicine practitioners and pharmacy practitioners in accordance with the regulations of the Minister of Health;”;

dd) To add Point dd after Point d, Clause 6 as follows:

“dd) Organizations and individuals specified at Points a, b and c of this Clause may only provide information on drugs that have been permitted to free sale in Vietnam.”.

38. To amend and supplement Clause 2 Article 78 as follows:

“2. The Minister of Health shall organize drug information and pharmacovigilance systems; define the forms and method of drug information provision.”.

39. To amend and supplement Clause 3 Article 79 as follows:

“3. The Government shall prescribe in detail drug advertising contents, and the dossier and procedures for receipt, appraisal and certification of drug advertising contents; prescribe the responsibilities of organizations and individuals performing and engaged in drug advertising.”.

40. To amend and supplement a number of clauses of Article 87 as follows:

a) To amend and supplement Clause 1 as follows:

“1. Stages 1, 2 and 3 of clinical trial shall be conducted before a drug is registered for circulation, except for regulations in Clause 1a of this Article.”;

b) To add Clause 1a after Clause 1 as follows:

“1a. In case of meeting the need for prevention and treatment of a class-A infectious disease already declared as an epidemic in accordance with the law on prevention and control of infectious diseases, the Minister of Health shall decide the grant of certificate of free sale for a drug undergoing clinical trial but must further monitor such drug’s safety and efficacy and control its objects, quantity and scope of use after the grant of certificate of free sale if the drug meet the following requirements:

a) There are results of mid-term assessment of stage 3 on the safety and therapeutic efficacy of the drug or the protective efficacy of the vaccine based on data on the immunogenicity of the vaccine approved by the National Council of Ethics in Biomedical Research;

b) There is a approval opinion of the advisory council for grant of certificates of free sale of drugs or drug materials.”.

41. To amend and supplement Point c Clause 3 Article 89 as follows:

“c) Drugs from medicinal materials which have certificates of free sale issued before January 01, 2017.”.

42. To amend and supplement Article 103 as follows:

“Article 103. Testing of drugs, drug materials and primary packages of drugs

1. Testing of drugs, drug materials and primary packages of drugs includes taking samples, considering their technical standards, and conducting relevant and necessary tests in order to identify the satisfaction of quality standards of drugs, drug materials and primary packages.

2. Drugs, drug materials and primary packages of drugs must be tested in accordance with the following regulations:

a) Before being used for drug manufacture, drug materials and primary packages of drugs shall be tested to ensure that they satisfy quality standards.

b) Before being delivered, drugs, drug materials and primary packages of drugs shall be tested by manufacturing establishments to ensure that they satisfy quality standards;

c) Establishments manufacturing drugs or drug materials may apply quality management measures that meet Good Manufacturing Practices for drugs or drug materials to replace one or several trials for the inspection and determination of the quality of drugs or drug materials specified at Points a and b of this Clause.

3. In addition to being tested under Clause 2 of this Article, the following drugs shall, before being put in circulation, be tested by a drug testing establishment designated by a competent state agency:

a) Vaccines;

b) Biological products which are antisera;

c) Other drugs as prescribed by the Ministry of Health, based on the results of assessment of drug quality risks and the situation of manufactured and imported drugs.

4. Exemption from one or more, or all, of the tests required in the testing process at the designated drug testing establishment shall be applied to vaccines and biological products which are antisera subject to testing under Clause 3 of this Article in one of the following cases:

a) They are imported from a country with which Vietnam has entered into a mutual recognition agreement regarding drug testing laboratories and drug testing results, or from a country whose quality evaluation results of drugs issued by the competent agency in charge of grant of certificates of quality or a certificate of pharmaceutical manufacturing are recognized and accepted by Vietnam;

b) They are used to meet urgent needs related to national defense and security, overcoming of consequences of incidents, natural disasters and catastrophes, epidemic prevention and control, or special treatment needs;

c) Where the results of risk assessment and quality trend evaluation in accordance with the Ministry of Health’s regulations demonstrate that the drugs meet the quality standards during its manufacture and circulation.

5. The Minister of Health shall detail this Article.”.

43. To amend and supplement Article 107 as follows:

“Article 107. Measures to manage drug prices

1. Bidding for national reserve drugs, bidding for drugs at medical establishments in accordance with the laws on bidding and national reserve.

2. Bidding, placement of orders or assignment of manufacture tasks for the supply of drugs for national target programs, national defense and security purposes, overcoming of consequences of incidents, natural disasters and catastrophes, epidemic prevention and control in accordance with the law regulations.

3. Making announcement or re-announcement of tentative wholesale price for prescription drugs, except for cases of exemption from announcement as prescribed by the Government for domestically manufactured drugs or drugs imported for non-commercial purposes.

4. Making recommendations on the tentative wholesale price of a drug that has been announced and re-announced during the drug's circulation on the market in case the Ministry of Health detects one of the following cases:

a) The tentative wholesale price of the drug exceeds the highest price of similar drug items previously announced or re-announced without any recommendation from the Ministry of Health, except for the case where the establishment submits an explanation report together with appropriate documentation justifying the price fluctuation.  In case such drug with the tentative wholesale price contains a content or concentration per dose differing from similar drug items, price comparisons shall be conducted based on equivalent conversion;

b) The differential between the tentative wholesale price of the drug and the winning bid for that same drug item exceeds the maximum differential stipulated by the Government, except for the case where the establishment submits an explanation report together with appropriate documentation justifying the price fluctuation;

c) In case there is no similar drug items currently circulating in Vietnam and the announced or re-announced tentative wholesale price of the drug is higher than its selling price in the country of origin or another country, except for the case where the establishment submits an explanation report together with appropriate documentation justifying the price fluctuation.

5. Declaring wholesale and retail prices of drugs on the list of essential drugs in accordance with the law on price.

6. Posting up wholesale and retail prices of drugs in accordance with the law on price.

7. Taking measures to stabilize drug prices in accordance with the law on price.

8. Negotiating drug prices in accordance with the law on price.

9. Conducting price negotiations in bidding for drugs eligible for application of the form of price negotiation in accordance with the law on bidding.

10. Setting the maximum retail surplus for drugs sold at drug retails within medical examination and treatment establishments.

11. The Government shall detail the announcement and re-announcement of tentative wholesale price for prescription drugs, and Clauses 4 and 10 of this Article.”.

44. To amend and supplement Article 109 as follows:

“Article 109. Responsibility of the Ministry of Health for state management of drug prices

The Ministry of Health shall assume the prime responsibility for, and coordinate with other ministries, ministerial-level agencies, government-attached agencies and provincial-level People’s Committees in, performing the state management of drug prices, having the following tasks:

1. To assume the prime responsibility for elaborating and submitting to competent state agencies for promulgation, or issue according to its competence, legal documents and organize the implementation of, policies and laws on drug prices;

2. To request other ministries, ministerial-level agencies, government-attached agencies and provincial-level People’s Committees to regularly or extraordinarily report on the management of drug prices;

3. To organize the dissemination of and education about the law on drug prices;

4. To take measures to stabilize drug prices in accordance with the price law;

5. To receive and review drug information in the dossiers of announcement and re-announcement of tentative wholesale prices and publish tentative wholesale prices on the Ministry of Health’s portal within 07 working days from the date of receiving the complete dossiers.

6. To publicize the Ministry of Health's recommendations on tentative wholesale prices that have been announced and re-announced under Clause 4, Article 107 of this Law;

7. To conduct examinations and inspections, and handle violations of the law on drug prices.”.

45. To amend and supplement Article 110 as follows:

“Article 110. Responsibility of the Ministry of Finance for state management of drug prices

To perform the function of state management of drug prices in accordance with the law on price.”.

46. To amend and supplement Clause 3 Article 112 as follows:

“3. To receive dossiers of declaration of drug prices declared or re-declared by establishments trading in drugs in the localities and update the information and data on declared drug prices in the national price database in accordance with the law on price.”.

47. To amend and supplement Article 113 as follows:

“Article 113. Responsibilities of the Viet Nam Social Security in management of drug prices

To announce successful bids of drugs paid by the health insurance fund on the Viet Nam Social Security's portal.”

48. To replace or repeal words or phrases in a number of points and clauses as follows:

a) To replace the phrase “drugs on the list of drugs under special control and the list of drugs restricted from retail” with the phrase “drugs under special control and drugs on the list of drugs restricted from retail” at Point b Clause 1 Article 48 and Point b Clause 1 Article 49;

b) To replace the phrase “m and n Clause 2 Article 42 of this Law” with the phrase “m, n and q Clause 2 Article 42 of this Law” at Point a Clause 2 Article 43, Point a Clause 2 Article 44, Clause 2 Article 45, Point a Clause 2 Article 46, Point a Clause 2 Article 51, Point a Clause 2 Article 52 and Point a Clause 2 Article 53;

c) To replace the phrase “Certified copies” in Clause 2 Article 24, Points c and d Clause 1, Points c and d Clause 2, Points b and c Clause 4 Article 38;

d) To replace the word “Copies” in Clause 2 Article 25, Clauses 2 and 3 Article 26.

49. To repeal Clause 6 Article 24, Clause 3 Article 78, Point b Clause 1 and Point b Clause 2 Article 89, Article 114.

Article 2. Amending and supplementing the Law No. 16/2023/QH15 on Price

To amend and supplement Section 9 of Appendix No. 01 - the list of goods and services subject to price valorization issued together with the Law No. 16/2023/QH15 on Price as follows:

“9. Drugs on the list of essential drugs.”.

Article 3. Implementation provisions

1. This Law takes effect on July 01, 2025, except for cases prescribed in Clause 2 of this Article.

2. The following regulations take effect on January 01, 2025:

a) Point a Clause 19, Point b Clause 20 and Point a Clause 21 Article 1 of this Law;

b) Regulations on extension of a certificate of free sale of drugs and drug materials defined in Clause 30 Article 1 of this Law.

3. Transitional provisions:

a) For dossiers of application for grant, modification and supplementation of the contents of certificates of free sale of drugs or drug materials and dossiers of request for certification or adjustment of drug information that have been submitted before July 01, 2015 but have not been yet settled, the Law No. 105/2016/QH13 on Pharmacy, which was amended and supplemented by the Law No. 28/2018/QH14 shall apply, except for cases where the establishments request application of this Law for settlement;

b) The declared and re-declared drug prices as prescribed in Clause 3, Article 107 of the Law No. 105/2016/QH13 on Pharmacy, which was amended and supplemented by the Law No. 28/2018/QH14, shall continue to be used and shall be considered as the tentative wholesale prices to be announced and re-announced as prescribed in this Law.

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This Law was adopted on November 21, 2024, by the XV^thNational Assembly of the Socialist Republic of Vietnam at its 8^th session.