Luật Dược sửa đổi 2024

LAW

AMENDMENTS TO CERTAIN ARTICLES OF THE LAW ON PHARMACY

Pursuant to the Constitution of the Socialist Republic of Vietnam;

The National Assembly hereby promulgates the Law on amendments to certain Articles of the Law on Pharmacy No. 105/2016/QH13 amended by the Law No. 28/2018/QH14.

Article 1. Amendments to certain Articles of the Law on Pharmacy

1. Several clauses of Article 2 are amended as follows:

a) Clause 5 is amended as follows:

“5. “herbal material” (including prepared traditional medicinal materials) means a medicinal material which is derived from plants, animals, minerals and mushrooms and satisfy standards for drug manufacture.”;

b) Clauses 8, 9 and 10 are amended as follows:

“8. “traditional drug” means a drug composed of one or more herbal materials which are combined according to traditional medicine theories principles or folk experience, processed and prepared according to traditional medicine methods; it may have a traditional or modern dosage form.

9. “prepared traditional medicinal material” means a herbal material undergoing primary processing and processing according to traditional medicine theories or folk experience for production and preparation of traditional drugs.

10. “biological” (also biopharmaceutical) means a drug that is the product of a bio-technological or biological process from a macromolecular substance or mixture of macromolecular substances extracted from biological sources, including microorganisms and derivatives of human blood and plasma.

Biologicals do not include in vitro diagnostic reagents, antibiotics and substances derived from biological sources that have small molecular weights and can be subdivided into pure substances.”;

c) Clauses 17, 18 and 19 are amended as follows:

“17. “narcotic drug” means a drug containing any active ingredient with neural stimulation or inhibition effects that easily causes addiction to its users and is included in the List of narcotic active ingredients promulgated by the Minister of Health, except for combination drugs that contain narcotic active ingredients specified in clause 20 of this Article.

18. “psychotropic drug” means a drug containing any active ingredient with neural stimulation or inhibition effects or hallucinogen that may cause addiction to its users if used many times and is included in the List of psychotropic active ingredients promulgated by the Minister of Health, except for combination drugs that contain psychotropic active ingredients specified in clause 21 of this Article.

19. “precursor drug” means a drug that contains any precursor on the List of drug precursors promulgated by the Minister of Health, except for combination drugs containing precursors specified in clause 22 of this Article.”;

d) Clause 27 is amended as follows:

“27. “Over-the-counter (OTC) drug” means a drug that may be dispensed, retailed, and used without a prescription, is determined according to the principles and criteria promulgated by the Minister of Health and is included in the list of OTC drugs promulgated by the Minister of Health.”;

dd) Clause 37 is amended as follows:

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

e) Clauses 44 through 50 are added after clause 43 as follows:

“44. “intended wholesale price” of a drug means the maximum wholesale price which is imposed by a drug importer or drug manufacturer before the first shipment is sold wholesale on the market. Drug business establishments must not sell the drug at a wholesale price higher than this.

45. “announcement of intended wholesale price” of a drug means a drug importer or drug manufacturer sending a notification of intended wholesale price to the Ministry of Health before selling the first drug shipment on the market so that it is publicly made available on the web portal of the Ministry of Health.

46. “re-announcement of intended wholesale price” of a drug means a drug importer or drug manufacturer sending a notification of intended wholesale price to the Ministry of Health upon a change to the announced intended wholesale price so that it is publicly made available on the web portal of the Ministry of Health.

47. “similar drugs” means the drugs with the same active ingredients, medicinal materials, dosage form and technical criteria.

48. “pharmacy chain” means a system of pharmacies operated by one facility organizing the pharmacy chain under a unified quality management system and a single trade name.

49. “substandard medicinal material” means a medicinal material that fails to meet the quality standards registered with or announced to a competent authority.

50. “high tech drug” means a drug on the List of high tech products approved by the Prime Minister or a drug produced and prepared using high technology on the List of high technologies approved by the Prime Minister.”.

2. Clause 3 of Article 4 is amended as follows:

“3. Other Ministries and ministerial agencies shall, within their jurisdiction, perform state management of pharmacy and management of banned substances that may only be used as medicinal materials and cooperate with the Ministry of Health in state management of pharmacy as per regulations of the Government.”.

3. Several points and clauses of Article 6 are amended as follows:

a) Clause 2 is amended as follows:

“2. Running a pharmacy business at a location other than the business location written on the Certificate of eligibility for pharmacy business or licensed by a competent authority, except for trading by e-commerce method.”;

b) Point i of clause 5 is amended as follows:

“i) Selling prescription drugs wholesale at prices higher than the announced or re-announced intended wholesale prices; selling drugs wholesale and retailing drugs at prices higher than listed prices.”;

c) Clause 8 is amended as follows:

“8. Practicing pharmacy in the working positions specified in Article 11 of this Law without a pharmacy practice certificate or outside the scope written on the pharmacy practice certificate or during the period of suspension of the pharmacy practice certificate.

d) Clauses 17, 18 and 18 are added after clause 16 as follows:

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

a) Prescription drugs, except during medical isolation after an epidemic of a Group A infectious disease is declared in accordance with regulations of law on prevention and control of infectious diseases;

b) Controlled drugs;

c) Drugs on the List of drugs restricted from retailing.

18. Retailing controlled drugs by e-commerce method.

19. Trading in drugs and medicinal materials by e-commerce method through means other than e-commerce trading platforms, e-commerce sales applications or websites (also e-commerce websites) with an online ordering function.”.

4. Article 7 is amended as follows:

“Article 7. State policies on pharmacy

1. Ensure adequate and timely supply of drugs of good quality at reasonable prices to serve the people’s need for prevention and treatment of diseases, suit the disease structure and meet the requirements for national defense and security, incident and disaster recovery, disease prevention and control.

2. Ensure the reasonable, safe, and effective use of drugs; formulate policies to develop clinical pharmacology and pharmacovigilance activities.

3. Provide incentives and assistance to develop the pharmaceutical industry into a spearhead industry.

4. Regulations of law on bidding and incentives in drug procurement shall apply to the procurement of the following drugs funded by state budget or other lawful funding sources of public health facilities:

a) Drugs researched and manufactured domestically from domestic materials, original brand-name drugs transferred to Vietnam under technology transfer contracts, the first domestically manufactured generic drugs, the first domestically manufactured biosimilars;

b) Herbal drugs, traditional drugs manufactured from domestic herbal materials satisfying Good Agricultural and Collection Practices for Herbal Materials;

c) Herbal drugs, traditional drugs manufactured as a result of accepted national, ministerial or provincial science and technology missions;

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

5. Give priority to the administrative procedures below:

a) Sequence, procedures and time for grant of drug/medicinal material marketing authorizations to new drugs; original brand-name drugs; rare drugs; vaccines; the first domestically manufactured generic drugs; the first domestically manufactured biosimilars; high tech drugs; drugs that have undergone clinical trial in Vietnam; drugs manufactured from herbal materials that satisfy Good Agricultural and Collection Practices for Herbal Materials; drugs and medicinal materials manufactured as a result of accepted national, ministerial or provincial science and technology missions; drugs satisfying requirements for national defense and security, incident and disaster recovery, disease prevention and control;

b) Criteria, sequence, procedures and time for licensing import of new drugs; rare drugs; vaccines that have been pre-qualified by World Health Organization (WHO); high tech drugs; drugs that have undergone clinical trial in Vietnam; drugs satisfying requirements for national defense and security, incident and disaster recovery, disease prevention and control.

6. Apply mechanisms for giving incentives and assistance from the National Technology Innovation Foundation, National Foundation for Science and Technology Development, National High-Tech Venture Capital Fund and other funds to support scientific and technological activities in the following cases:

a) Research into, development, clinical trial, technology transfer, manufacturing and commercialization of medicinal materials, new drugs, vaccines, biologicals, high-tech drugs, the first domestically manufactured generic drugs, traditional drugs in modern dosage forms, herbal drugs manufactured as a result of accepted national or ministerial science and technology missions;

b) Investment in establishment and development of clinical trial centers in development of new drugs, in vivo bioequivalence studies, and biosimilar studies.

7. Combine investment from state budget and investment from other sources in development of the manufacture of vaccines, biologicals, herbal drugs, traditional drugs, drugs manufactured from domestic herbal materials, the first domestically manufactured generic drugs; cultivation and production of herbal materials; discovery, conservation and application of science and technology to research into and development of genetic resources of rare and special herbal materials.

8. Support and facilitate the discovery, clinical trial, marketing authorization, registration of protection of intellectual property rights and inheritance of traditional drugs and herbal drugs manufactured as a result of accepted national or ministerial science and technology missions; exploration, collection and use of new herbal materials; export of cultivated herbal materials; acclimatization of herbs; reasonable collection of natural herbal materials; research, survey and investigation into appropriate species of herbal materials for cultivation in localities; development of herbal material cultivation areas; modernization of the manufacture and formulation of trade promotion policies for export of herbal drugs and traditional drugs.

9. Introduce policies to protect confidentiality of information about concoction and data on clinical trial of traditional drugs; accord reasonable treatment to donors of precious traditional remedies to the State; facilitate the issuance of traditional medicine practice certificates to holders of hereditary remedies recognized by the Ministry of Health.

10. Encourage development of the drug supply system towards professionalism, modernity and efficiency; ensure timely and adequate supply of drugs of good quality to meet the people’s need for drugs; encourage pharmacies and dispensaries to open 24/7.

Provide incentives and support for development of the drug supply system and mobile drug retailers in ethnic minority areas, in mountainous areas, on islands, in disadvantaged areas and extremely disadvantaged areas.

11. Mobilize health facilities of the people’s armed forces and military-civil medical examination and treatment facilities to participate in supply of drugs and cultivation of herbal materials to meet the needs for prevention and treatment of diseases of the people in ethnic minority areas, in mountainous areas, on islands, in disadvantaged areas and extremely disadvantaged areas.

12. Introduce policies to improve quality of pharmacy human resources, support training of high quality human resources in research into, development, receipt and transfer of technology, production and trial of new drugs, original brand-name drugs, high-tech drugs, herbal drugs and traditional drugs.

13. Establish policies to maintain and reduce prices of new drugs, original brand-name drugs, high-tech drugs, vaccines, and rare drugs transferred to Vietnam under production technology transfer contracts.

14. Implement policies to control the quantity of marketing authorizations for drugs with the same active ingredients and herbal materials suitable for the socio-economic conditions from time to time.

15. Give priority to investment in development of information technology infrastructure and digital transformation in pharmacy activities.

16. The Government shall elaborate this Article.”.

5. Article 8 is amended as follows:

“Article 8. Investment incentives and assistance in development of pharmaceutical industry

1. Provide investment incentives and assistance to investment projects in the pharmacy field in accordance with regulations of law on investment.

2. Each project on investment in establishment (including the expansion of such establishment project) in development of pharmaceutical industry which has a total investment capital of at least VND 3,000 billion and disburses at least VND 1,000 billion within 03 years from the issuance date of the investment registration certificate or the approval for investment guidelines will be eligible for the special investment incentives and assistance applied to the object specified in point a clause 2 Article 20 of the Law on Investment, including:

a) Research into and development of technology, manufacture or transfer of technology for manufacture of herbal drugs, traditional drugs manufactured from domestic herbal materials, active ingredients, new drugs, original brand-name drugs, rare drugs, the first domestically manufactured generic drugs, high-tech drugs, vaccines, biologicals;

b) Cultivation of herbal materials in disadvantaged areas or extremely disadvantaged areas;

c) Research in service of conservation and development of genetic resources of domestic precious, rare and endemic herbal materials; creation of new varieties from genetic resources of herbal materials of high economic value.

3. The Government shall elaborate this Article.”.

6. Several points and clauses of Article 10 are amended as follows:

a) Point a of clause 3 is amended as follows:

“a) Preside over and cooperate with the Ministry of Health and Ministry of Science and Technology in formulating legislative documents serving the management and organization of selection and creation of varieties of herbal materials, cultivation and collection of herbal materials; dissemination of techniques for cultivation, prevention and control of diseases and pests on medicinal plants and animals;”;

b) Point a of clause 6 is amended as follows:

“a) Request competent authorities to provide or provide within its power funding for implementation of plans and programs for development of pharmaceutical industry in accordance with regulations of the Law on State Budget;”;

c) Clause 7 is amended as follows:

“7. The Ministry of Science and Technology has the responsibilities to:

a) Request competent authorities to provide or provide within its power annual funding from state budget for scientific and technological activities to conduct research and apply research findings to manufacture of drugs as prescribed by law, especially those on the List of national products;

b) Preside over and cooperate with the Ministry of Agriculture and Rural Development and Ministry of Health in researching, conserving and sustainably using genetic resources of precious, rare and endemic herbal materials; conduct research to select and create varieties of herbal materials, prevent and control diseases and pests on medicinal plants and animals, and collect herbal materials;

c) Preside over and cooperate with the Ministry of Health in developing mechanisms and policies for protection of intellectual property of traditional drugs;

d) Preside over and cooperate with other Ministries and ministerial agencies concerned in formulating mechanisms and policies for application of science and technology for development of the pharmaceutical chemistry industry.”;

d) Point b of clause 8 is amended as follows:

“b) Provide land for construction of factories, pharmaceutical industrial parks, projects on development of herbal materials and herbal material cultivation areas in accordance with regulations of law on land.”.

7. Point b clause 1 of Article 12 is amended as follows:

“b) A person whose pharmacy practice certificate is revoked as prescribed in Article 28 hereof.

The pharmacy practice certificate shall only be issued after 24 months from the revocation date in the cases where it is revoked as prescribed in clauses 4, 6, 10 and 11 Article 28 hereof.”.

8. Article 17a is added after Article 17 as follows:

“Article 17a. Conditions to be satisfied by the chief pharmacist of a facility organizing the pharmacy chain or a pharmacy in the pharmacy chain

1. The chief pharmacist of a facility organizing the pharmacy chain must have any of the qualifications specified in point a clause 1 Article 13 hereof and 02 years’ apprenticeship at a suitable pharmacy establishment.

2. The chief pharmacist of each pharmacy in the pharmacy chain must satisfy the conditions set out under clause 1 Article 18 hereof.”.

9. Clause 7 of Article 24 is amended as follows:

“7. A criminal record, except where the criminal record database is updated and shared with the application receiving authority in accordance with the Government's regulations.

If the applicant is a foreigner or overseas Vietnamese, it is required to have a criminal record or certification issued by a foreign competent authority that the applicant is not a criminal or facing criminal prosecution, not banned from pharmacy practice or banned from doing pharmaceutical works under a court’s judgment or decision.”.

10. Clause 8 of Article 28 is amended as follows:

“8. A person issued with the pharmacy practice certificate fails to conduct any activity within the scope written on the pharmacy practice certificate practice for 24 consecutive months.”.

11. Several clauses of Article 31 are amended as follows:

a) Clause 3 is amended as follows:

“3. Be only responsible for professional activities of only one pharmacy business establishment and at only one pharmacy business location, except for the case specified in clause 3a of this Article.”;

b) Clause 3a is added after clause 3 as follows:

“3a. The chief pharmacist of a facility organizing the pharmacy chain must be the chief pharmacist of the entire pharmacy chain.”.

12. Several points and clauses of Article 32 are amended as follows:

a) Point a of clause 1 is amended as follows:

“a) Trading in drugs and medicinal materials, including trading in drugs and medicinal materials by e-commerce method on e-commerce trading platforms, e-commerce sales applications or e-commerce sales websites with an online ordering function;”;

b) Point i is added after point h of clause 2 as follows:

“i) Facilities organizing pharmacy chain.”.

13. Point h is added after point g clause 2 of Article 33 as follows:

“h) Every facility organizing pharmacy chain must satisfy the conditions prescribed in point c of this clause, have at least 02 affiliated pharmacies issued with the Certificate of eligibility for pharmacy business and a uniform quality management system to be applied to all pharmacies in the chain.”.

14. Point d clause 1 of Article 35 is amended as follows:

“d) Any health facility of the people’s armed forces or military-civil medical examination and treatment facility supplying drugs in ethnic minority areas, in mountainous areas, on islands, in disadvantaged areas and extremely disadvantaged areas.”.

15. Clause 3 of Article 36 is amended as follows:

“3. The Certificate of eligibility for pharmacy business shall be adjusted in the following cases:

a) Change of the name of the establishment or business location;

b) Change to the scope of pharmacy business without changing the conditions for pharmacy business;

c) Change to information about the chief pharmacist written on the Certificate of eligibility for pharmacy business, except for secondment of chief pharmacists among pharmacies in the pharmacy chain.”

16. Clause 1 of Article 37 is amended as follows:

“1. The Minister of Health shall issue, re-issue, adjust and revoke Certificates of eligibility for pharmacy business of the pharmacy business establishments mentioned in point a, b, c, e, g, h and i clause 2 of Article 32 hereof.”.

17. Several points are added to Article 38 as follows:

a) Point dd is added after point d of clause 1 as follows:

“dd) A list of pharmacies in the pharmacy chain issued with the Certificate of eligibility for pharmacy business by the time of submission if the applicant is a facility organizing the pharmacy chain.”;

b) Point dd is added after point d of clause 2 as follows:

“dd) A list of pharmacies in the pharmacy chain issued with the Certificate of eligibility for pharmacy business by the time of submission if the applicant is a facility organizing the pharmacy chain.”.

18. Several points and clauses of Article 42 are amended as follows:

a) Point dd of clause 1 is amended and point e is added after point dd of clause 1 as follows:

“dd) Establish mobile drug retailers in ethnic minority areas, in mountainous areas, on islands, in disadvantaged areas and extremely disadvantaged areas as prescribed by the Government;

e) Purchase and sell prescription drugs from the date on which the Ministry of Health receives the dossiers on announcement or re-announcement of intended wholesale prices from drug manufacturers and importers.”;

b) Point q is added after point p of clause 2 as follows:

“a) Take legal responsibility for the accuracy, legitimacy and truthfulness of the documents provided to competent authorities.”;

c) Clause 4 is added after clause 3 as follows:

“4. Apart from the rights and responsibilities specified in clauses 1, 2 and 3 of this Article, upon conducting business by e-commerce method, the pharmacy business establishment has the following rights and responsibilities:

a) Comply with regulations of law on e-transactions, law on e-commerce, law on advertising, law on protection of consumers’ rights and other relevant regulations of law;

b) Ensure confidentiality of information of purchasers as prescribed by law;

c) Fully post information on the Certificate of eligibility for pharmacy business and pharmacy practice certificate of its chief pharmacist and information about approved drugs as prescribed by the Government;

d) Notify the pharmacy business by e-commerce method to competent authorities in accordance with regulations imposed by the Minister of Health;

dd) Each drug retailer must provide online advice and instructions for drug use to drug purchasers and deliver drugs to purchasers in accordance with regulations imposed by the Minister of Health;

e) Only retail OTC drugs which are not controlled drugs and not included in the List of drugs restricted from retailing.

Retail prescription drugs as prescribed by the Minister of Health in the case of medical isolation after an epidemic of a Group A infectious disease is declared in accordance with regulations of law on prevention and control of infectious diseases;

g) Only sell drugs and medicinal materials other than controlled drugs wholesale;

h) Comply with other Government's regulations on selling drugs and medicinal materials and drugs wholesale by e-commerce method.”.

19. Several points and clauses of Article 43 are amended as follows:

a) Point e of clause 1 is amended as follows:

“e) Sell wholesale drugs and medicinal materials which it manufactures to medical examination and treatment facilities, immunization facilities and other health facilities; rehabilitation centers; state-owned drug and medicinal material testing facilities; science and technology organizations, training institutions conducting research and teaching activities related to pharmacy; pharmacy business establishments specified in clause 2 Article 32 of this Law; establishments that have been granted a Certificate of registration of investment in drug manufacture but have not been granted a Certificate of eligibility for pharmacy business for experimental production of drugs and evaluation of the drug manufacturing process;”;

b) Point e is added after point dd of clause 2 as follows:

“e) Announce and re-announce intended wholesale prices of drugs as prescribed in this Law.”.

20. Several points and clauses of Article 44 are amended as follows:

a) Point a of clause 1 is amended as follows:

“a) The rights specified in points a, b, c, d and e clause 1 Article 42 hereof;”;

d) Point d of clause 1 is amended as follows:

“d) Sell wholesale drugs and medicinal materials which it imports to medical examination and treatment facilities, immunization facilities and other health facilities; rehabilitation centers; state-owned drug and medicinal material testing facilities; science and technology organizations, training institutions conducting research and teaching activities related to pharmacy; pharmacy business establishments specified in clause 2 Article 32 of this Law; establishments that have been granted a Certificate of registration of investment in drug manufacture but have not been granted a Certificate of eligibility for pharmacy business for experimental production of drugs and evaluation of the drug manufacturing process;”;

c) Point c is added after point b of clause 2 as follows:

“c) Announce and re-announce intended wholesale prices of drugs as prescribed in this Law.”.

21. Several points and clauses of Article 46 are amended as follows:

a) Point b of clause 1 is amended as follows:

“b) Sell drugs and medicinal materials wholesale to medical examination and treatment facilities, immunization facilities and other health facilities; rehabilitation centers; state-owned drug and medicinal material testing facilities; science and technology organizations, training institutions conducting research and teaching activities related to pharmacy; pharmacy business establishments specified in clause 2 Article 32 of this Law; establishments that have been granted a Certificate of registration of investment in drug manufacture but have not been granted a Certificate of eligibility for pharmacy business for experimental production of drugs and evaluation of the drug manufacturing process;”;

b) Point c is added after point b of clause 2 as follows:

“c) Declare drug wholesale prices of drugs as prescribed in clause 5 Article 107 hereof.”.

22. Several points and clauses of Article 47 are amended as follows:

a) Point b of clause 1 is amended as follows:

“b) Purchase medicinal materials to compound drugs and sell them or the right specified in point b clause 3 Article 47a of this Law. The chief pharmacist of a pharmacy shall directly manage compounding of drugs therein.”.

b) Point d is added after point c of clause 2 as follows:

“d) Declare drug retail prices as prescribed in clause 5 Article 107 hereof.”.

23. Article 47a is added after Article 47 as follows:

“Article 47a. Rights and responsibilities of facilities organizing pharmacy chain, pharmacies in pharmacy chain

1. A facility organizing the pharmacy chain has the following rights:

a) The rights specified in clause 1 Article 42 hereof;

b) Purchase medicinal materials to deliver them to pharmacies in the pharmacy chain to compound drugs and sell them at the compounding pharmacies;

c) Purchase drugs to deliver them to pharmacies in the pharmacy chain for retail, except for vaccines. In case of purchasing controlled drugs and drugs on the List of drugs restricted from retailing, comply with the regulations set out under Article 34 of this Law;

b) Circulate drugs between drug warehouses of the facility organizing the pharmacy chain and pharmacies in the pharmacy chain, except for compounded drugs. The drug circulation shall be coordinated by the chief pharmacist of the facility organizing pharmacy chain;

dd) Second chief pharmacists of pharmacies in the pharmacy chain.

2. A facility organizing the pharmacy chain has the following responsibilities:

a) The responsibilities specified in points a, b, c, d, dd, h, k, l, m, n and q clause 2 Article 42 hereof;

b) Tailor a quality management system for the pharmacy chain, including organizational structure, processes, personnel, documents, information system, administration system, technical infrastructure and systematic activities, which satisfies Good Practices and suits the scope of business;

c) Manage all activities related to the supply, circulation, preservation of drugs and medicinal materials and customer-related data at all pharmacies in the pharmacy chain by unified processes;

d) Supply the entire drugs and medicinal products to pharmacies in the pharmacy chain;

dd) Take total responsibility for activities of pharmacies in the pharmacy chain;

e) Report to the Ministry of Health or Department of Health of the province where the pharmacy in the pharmacy chain operates and fulfill the obligations as prescribed by law in the cases where any pharmacy in the pharmacy chain has suspended its operation for at least 06 months or shut down;

g) Comply with regulations of the Minister of Health on notifying and updating the following to the competent authority: the list of pharmacies in the pharmacy chain; list of practitioners having pharmacy practice certificates at the facility organizing pharmacy chain and pharmacies in the pharmacy chain; secondment of chief pharmacists among pharmacies in the pharmacy chain;

h) Submit to competent pharmacy authorities annual and ad hoc reports on operations of the facility organizing pharmacy chain and pharmacies in the pharmacy chain; notify the Ministry of Health within 03 working days from the date on which a pharmacy in the pharmacy chain incurs a penalty for administrative violations in the field of pharmacy.

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

a) The rights specified in points a, d and dd clause 1 Article 47 hereof;

b) Receive medicinal materials from the facility organizing pharmacy chain to compound drugs and sell them at the pharmacy. The chief pharmacist of a pharmacy shall directly manage compounding of drugs therein;

c) Receive drugs from the facility organizing pharmacy chain for retail, except for vaccines; in case of purchasing controlled drugs and drugs on the List of drugs restricted from retailing, comply with the regulations set out under Article 34 of this Law.

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

a) The responsibilities specified in 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 and clause 2 Article 81 of this Law;

b) Only trade in drugs supplied by the facility organizing pharmacy chain;

c) Comply with the quality management system built by the facility organizing pharmacy chain;

d) Suspend its operation in case the facility organizing pharmacy chain has suspended its operation for at least 06 months;

dd) Shut down in case the facility organizing pharmacy chain shuts down.”.

24. Point c is added after point b clause 2 of Article 48 as follows:

“c) Declare drug retail prices as prescribed in clause 5 Article 107 hereof.”.

25. Point c is added after point b clause 2 of Article 49 as follows:

“c) Declare drug retail prices as prescribed in clause 5 Article 107 hereof.”.

26. Point c is added after point b clause 2 of Article 50 as follows:

“d) Declare retail prices of herbal drugs and traditional drugs as prescribed in clause 5 Article 107 hereof.”.

27. Article 53a is added after Article 53 in Chapter IV as follows:

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

1. The pharmacy business establishments that are prescribed in points a, b, e, g and h clause 2 Article 32 of this Law and have foreign investment have the following rights:

a) The rights specified in points b, c and d clause 1 Article 42 hereof;

b) The rights corresponding to the type of pharmacy business establishments specified in 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, and points b, c, d and dd clause 1 Article 53 of this Law.

2. Drug and medicinal material manufacturers that have foreign investment have the rights specified in clause 1 of this Article and the following rights:

a) Sell wholesale, deliver and transport drugs and medicinal materials which they manufacture or are obtained by the manufacturers under processing contracts or transferred to Vietnam under technology transfer contracts to medical examination and treatment facilities, immunization facilities and other health facilities; rehabilitation centers; state-owned drug and medicinal material testing facilities; science and technology organizations, training institutions conducting research and teaching activities related to pharmacy; pharmacy business establishments specified in clause 2 Article 32 of this Law; establishments that have been granted a Certificate of registration of investment in drug manufacture but have not been granted a Certificate of eligibility for pharmacy business for experimental production of drugs and evaluation of the drug manufacturing process.

In case of selling prescription drugs, the drug manufacturers are entitled to sell them from the date on which the Ministry of Health receives the dossiers on announcement or re-announcement of intended wholesale prices of drugs;

b) Deliver and transport drugs under sponsorship, aid, humanitarian aid, and disease prevention and control programs to health facilities receiving sponsorship.

3. Drug and medicinal material importers that have foreign investment have the rights specified in clause 1 of this Article and the following rights:

a) Sell wholesale drugs and medicinal materials which the importers import to wholesalers of drugs and medicinal materials. In case of selling prescription drugs, the drug importers are entitled to sell them from the date on which the Ministry of Health receives the dossiers on announcement or re-announcement of intended wholesale prices of drugs;

b) Repurchase drugs and medicinal materials which are transferred to Vietnam by the importers under technology transfer contracts; sell drugs and medicinal materials which are obtained by the importers under processing contracts or transferred to Vietnam by the importers under technology transfer contracts to wholesalers of drugs and medicinal materials;

c) Import medicinal materials within the scope mentioned in the Certificate of eligibility for pharmacy business to supply them to manufacturers of drugs which are obtained by the importers under processing contracts or transferred to Vietnam by the importers under processing contracts or technology transfer contracts;

d) Deliver and transport drugs and medicinal materials which the importers import, are obtained by the importers under processing contracts or are transferred to Vietnam by the importers under technology transfer contracts from the importers’ warehouses of drugs and medicinal materials to wholesalers of drugs and medicinal materials;

dd) Deliver and transport drugs under sponsorship, aid, humanitarian aid, and disease prevention and control programs to health facilities receiving sponsorship;

e) Transport medicinal materials which the importers import from the importers’ warehouses of medicinal materials to manufacturers of drugs which are obtained by the importers under processing contracts or are transferred to Vietnam by the importers under processing contracts or technology transfer contracts; transport drugs used for clinical trial which the importers sponsor and import to clinical trial facilities.

4. The pharmacy business establishments specified in points a, b, e, g and h clause 2 Article 32 that have foreign investment have the responsibilities corresponding to each type of pharmacy business establishment specified in clause 2 Article 42, clause 2 Article 43, clause 2 Article 44, clause 2 Article 51, and clause 2 Article 53 of this Law and are not permitted to conduct activities directly related to distribution of drugs and medicinal materials, including:

a) Selling, delivering and transporting drugs and medicinal materials, except for the case specified in clauses 2 and 3 of this Article;

b) Preserving drugs and medicinal materials which the importers do not import or manufacture, are not obtained by the importers under processing contracts or are not transferred to Vietnam by the importers under technology transfer contracts;

c) Receiving orders and payments for drugs and medicinal materials from medical examination and treatment facilities, retailers, individuals, organizations other than wholesalers of drugs and medicinal materials, except for the case specified in clause 2 of this Article;

d) Determining and impose selling prices of drugs and medicinal materials distributed by other pharmacy business establishments, except where regulations on drug price management in this Law are implemented;

dd) Determining and impose selling prices of drugs and medicinal materials distributed by other pharmacy business establishments, except where regulations on drug price management in this Law are implemented;

e) Formulating plans for supply of drugs and medicinal materials of medical examination and treatment facilities in Vietnam;

g) Providing financial support in any shape or form to organizations and individuals directly purchasing drugs and medicinal materials of the pharmacy business establishments for the purpose of manipulating the distribution of imported drugs and medicinal materials.

5. Foreign-invested pharmacy business establishments are not permitted to retail drugs and sell drugs and medicinal materials wholesale, except for the case specified in clauses 2 and 3 of this Article.”.

28. Point b clause 1 of Article 54 is amended as follows:

“b) Imported drugs prescribed in clauses 2 and 5a Article 60 hereof;”.

29. Point b and point c clause 2 of Article 55 are amended as follows:

“b) The drug already has a marketing authorization but there are changes to its active ingredients, herbal materials; contents, concentrations, weight of active ingredients or herbal materials in a dosage unit; dosage form; manufacturer, except for change or addition of packaging facility, releasing facility, or releasing location;

c) The medicinal material already has a marketing authorization but there is a change or addition of its manufacturer, except for change or addition of a packaging facility, releasing facility, or releasing location.”.

30. Article 56 is amended as follows:

“Article 56. Power, documentation requirements, procedures and time limit for issuing, renewing and revising marketing authorizations

1. The Ministry of Health shall issue, renew and revise marketing authorizations of drugs and medicinal materials through application validation and consultancy of the Marketing Authorization Advisory Board, except for the case specified in point b clause 9 of this Article.

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

a) Information about issuance, renewal or revision of marketing authorizations of drugs and medicinal materials;

b) The case specified in point c clause 8 of this Article;

c) OTC drugs after being granted the drug marketing authorization.

3. An application for issuance of marketing authorization of a drug or medicinal material consists of:

a) Administrative documents, including an application form; unexpired license for establishment of representative office (for foreign applicants) or unexpired Certificate of eligibility for pharmacy business (for Vietnamese applicants); unexpired Certificate of pharmaceutical product (for imported drugs); sample label of drug/medicinal material; information about the drug and other documents about trading and marketing authorization of the drug or medicinal material.

In case of serving the purpose of meeting the needs for prevention and treatment of any group A infectious disease that causes an epidemic to be declared in accordance with regulations of law on prevention and control of infectious diseases, the certificate of pharmaceutical product may be replaced by another document issued by a competent authority confirming that the drug is permitted for marketing authorization and use in the home country and fully stating information about name and address of the manufacturing facility and conditions for licensing;

b) Technical documents proving that the drug or medicinal material satisfies the conditions in clause 4 Article 54 of this Law; for new drugs, reference biologicals and vaccines, it is required to have clinical documents proving their safety and efficacy; for biosimilars, it is required to have documents proving their quality, safety and efficacy in comparison to a reference biological; for drugs requiring bioequivalence study, it is required to have a report on data on their bioequivalence study; in case the applicant wishes to use reference to the result of validation of the marketing authorization application, it is required to have documents on the validation results of a Stringent Regulatory Authority (SRA) or a regulatory authority recognized by the Ministry of Health based on the WHO classification.

For new domestically manufactured drugs (except vaccines) that have indications for use in prevention and treatment of prevention and treatment of any group A infectious disease that causes an epidemic to be declared in accordance with regulations of law on prevention and control of infectious diseases and have the same active ingredients, dosage form and administration route as those of the drugs granted a marketing authorization or license for use in case of emergency or granted a conditional marketing authorization or license for conditional use by one of the stringent regulatory authorities (SRAs) or a regulatory authority recognized by the Ministry of Health based on the WHO classification, the clinical document in a marketing authorization application will be exempt;

c) A sample label of the drug or medicinal material marketed in the home country or reference country (for imported drugs).

4. An application for renewal of marketing authorization of a drug or medicinal material consists of:

a) An application form for renewal;

b) The unexpired Certificate of pharmaceutical product (for imported drug);

dd) A report on safety and efficacy of the drug during its marketing.

5. An application for revision of marketing authorization of a drug or medicinal material consists of:

a) A form for application for revision;

b) Tehnical documents about the variations.

6. Time limit for issuing, renewing or revising a marketing authorization of a drug or medicinal material is prescribed as follows:

a) Within 12 months from the date of receiving a sufficient application specified in clause 3 of this Article, except for the cases specified in points b and e of this clause;

b) Within 09 months from the date of receiving a sufficient application specified in clause 3 of this Article in case of using reference to the validation result;

c) Within 03 months from the date of receiving a sufficient application specified in clause 4 of this Article;

d) Within 03 months from the date of receiving a sufficient application specified in clause 5 of this Article, except for the case specified in point dd of this clause;

dd) Within 20 days from the date of receiving a sufficient application specified in clause 5 of this Article in case the revision to the marketing authorization of drug or medicinal material does not affect the quality, safety and efficacy of the drug;

e) Within 15 days from the date of receiving a sufficient application specified in clause 3 of this Article regarding the application for marketing authorization of a new drug which has indications for use in prevention and treatment of prevention and treatment of any group A infectious disease that causes an epidemic to be declared, is granted a marketing authorization or license for use in case of emergency is granted a conditional marketing authorization or license for conditional use by one of the stringent regulatory authorities (SRAs) or a regulatory authority recognized by the Ministry of Health based on the WHO classification.

7. The Ministry of Health shall issue, renew and revise marketing authorizations of drugs and medicinal materials within the time limits specified in clause 6 of this Article; in case an application for issuance, renewal or revision of a marketing authorization of drug or medicinal material is rejected, a written explanation must be provided.

In case a drug has been granted the marketing authorization but has not been marketed within 05 years from the effective date of the drug marketing authorization, it is not permitted to renew the marketing authorization of the drug, except for rare drugs or any drug that has no more than 03 drugs (having the same active ingredients, dosage form, contents or concentrations of active ingredients, weight of medicinal materials in a dosage unit) of 03 manufacturers that have been granted the drug marketing authorization which remains effective.

8. Effective period of a marketing authorization of a drug or medicinal material is prescribed as follows:

a) A marketing authorization of a drug or medicinal material is valid for 05 years from its issuance or renewal date, except for the cases in points b and c of this clause;

b) A marketing authorization of a drug whose safety and efficacy still has to be monitored is valid for 03 years from its issuance or renewal date;

c) When a marketing authorization of drug or medicinal material expires after the Ministry of Health receives an application for renewal thereof, it may be used until it is officially renewed or the Ministry of Health issues a notification that the application is rejected or the marketing authorization is suspended in case the drug or medicinal material is found potentially unsafe for users or legal documents are suspected of being forged.

9. The Minister of Health shall elaborate required documentation for issuance, renewal and revision of marketing authorizations of drugs and medicinal materials specified in clauses 3, 4 and 5 of this Article and specify the following regulations:

a) Procedures for issuance, renewal and revision of marketing authorizations of drugs and medicinal materials;

b) Cases where an application for renewal or revision of marketing authorization of drug or medicinal material does not require validation and consultancy by the Marketing Authorization Advisory Board on the basis of assessing risks related to the quality, safety and efficacy of the drug or medicinal material;

c) Cases where the marketing authorization is granted to a new drug which has indications for use in prevention and treatment of any group A infectious disease that causes an epidemic to be declared on the basis of recognizing the result given by one of the stringent regulatory authorities (SRAs) or a regulatory authority recognized by the Ministry of Health based on the WHO classification without validating technical documents and inspecting the compliance with Good Manufacturing Practice.”.

31. Point b clause 1 of Article 59 is amended as follows:

“b) Imported drugs and medicinal materials prescribed in clauses 1, 2, 3, 4 and 5a Article 60 hereof;”.

32. Several points and clauses of Article 60 are amended as follows:

a) Points h and i of clause 2 are amended as follows:

“h) It is used for bioequivalence study, bioavailability assessment, as a sample for registration, testing, scientific research, or display at a fair or exhibition;

i) It is used for other non-commercial purposes, including the case where it is imported by a medical examination and treatment facility to serve its patients' needs for special treatment.”;

b) Clause 3 is amended as follows:

“3. A medicinal material that is an active ingredient that does not have a marketing authorization in Vietnam shall be licensed for import with a quantity not exceeding that written on the import license in the following cases:

a) It is used as a sample for registration, testing, drug study, or display at an exhibition or fair;

b) It is used for manufacture of drugs for export, semi-finished drugs for export, drugs serving purposes related to national defense and security, prevention and treatment of any group A infectious disease that causes an epidemic to be declared in accordance with regulations of law on prevention and control of infectious diseases, or incident and disaster recovery; manufacture and compounding in service of needs for medical treatment at medical examination and treatment facilities.”;

c) Clauses 5a and 5b are added after clause 5 as follows:

“5a. Drugs that have not been granted a drug marketing authorization in Vietnam and are used for clinical trial may be imported without the import license with the quantity and type published on the web portal of the Ministry of Health on the basis of the clinical trial protocol approved by the Ministry of Health, except for drugs specified in clause 4 of this Article.

5b. The Minister of Health shall consider and decide the use of active ingredients and herbal materials for manufacture of drugs granted the marketing authorization and having indications for use in prevention and treatment of any group A infectious disease that causes an epidemic to be declared in accordance with regulations of law on prevention and control of infectious diseases with regard to active ingredients and herbal materials licensed for import to be used for other purposes.”;

d) Clause 6a is added after clause 6 as follows:

“6a. The Ministry of Finance shall periodically share data on controlled drugs granted customs clearance for export and import with the Ministry of Health in accordance with the Government’s regulations.”

dd) Clause 7 is amended as follows:

“7. The Government shall elaborate the following contents:

a) Criteria, documentation requirements, procedures, time limit for issuance of export licenses and import licenses regarding the drugs mentioned in clause 2 through 5 of this Article and the List of drugs and medicinal materials banned from import and/or production;

b) Import of herbal materials, excipients, capsule shells and primary packages of drugs;

c) Forms for the import of drugs as specified in clause 5a, documentation requirements, procedures and time limit for the repurposing of materials as specified in clause 5b of this Article;

d) The transfer of drugs specified in point c clause 2 of this Article; the supply of drugs imported by medical examination and treatment facilities to serve special treatment needs specified in point i clause 2 of this Article to other medical examination and treatment facilities.”.

33. Clause 3 is added after clause 2 of Article 62 as follows:

“3. The Government shall elaborate the recall of medicinal materials and disposal of recalled medicinal materials.”.

34. Several points and clauses of Article 64 are amended as follows:

a) Points dd and e of clause 1 are amended as follows:

“dd) Submit a report on the drug recall and its result to the Ministry of Health and also the Department of Health in case the latter issues a recall decision;

e) Submit a report on voluntary recall of drugs to the Ministry of Health.”;

b) Clause 2 is amended as follows:

“2. Wholesalers of drugs and medicinal materials, drug retailers and facilities organizing pharmacy chain have the responsibility to:

a) Stop selling, supplying and dispensing the drugs recalled;

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

c) Return recalled drugs to the supplier;

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

c) Points a and b of clause 4 are amended as follows:

“a) Decide drug recalls and disposal of recalled drugs nationwide in consideration of the degree of violations in terms of drug quality, safety, and efficacy; update information about recalled drugs and disposal thereof on the web portal of the Ministry of Health and pharmacy information system in the national health database;

b) Re-determine the degree of violations and request pharmacy business establishments to adjust the scope and time of recall in a manner that suits the degree of violations re-determined as prescribed in clauses 2 and 3 Article 63 of this Law within 24 hours since the receipt of the report on voluntary drug recall from the pharmacy business establishments;”;

d) Clause 4a is added after clause 4 as follows:

“4a. Each Department of Health shall:

a) Decide drug recalls as prescribed in clause 2 Article 65 of this Law in consideration of the degree of violations in terms of drug quality, safety, and efficacy and report the drug recalls to the Ministry of Health; update information about recalled drugs and disposal thereof on the web portal of its province or central-affiliated city and pharmacy information system in the national health database;

b) Issue notifications of suspension from marketing and recall of drugs in its locality according to the drug recall decision issued by the Ministry of Health;

c) Inspect and supervise the organization of drug recalls and recall drugs in its locality and impose penalties on violators as prescribed by law.”.

35. Article 65 is amended as follows:

“Article 65. Power to decide drug recalls and procedures for recalling drugs

1. The Ministry of Health shall issue a decision on mandatory recall of a drug in the following cases:

a) The drug is involved in a first-degree violation;

b) The drug is involved in a second- or third-degree violation through the manufacturer’s or importer’s fault;

c) The drug is recalled in at least 02 provinces or central-affiliated cities.

2. Every Department of Health shall issue decisions on mandatory drug recall in case of second- or third-degree violations found in its province and submit reports thereon to the Ministry of Health.

3. A decision on drug recall shall be issued within 24 hours after it is concluded that the drug has to be recalled and the is involved in a violation to a certain degree.

4. In case additional information is needed to form a basis for determining the degree of violation, within 24 hours after receiving a report from the Department of Health or state-owned drug and medicinal material testing facility, the Ministry of Health shall issue a written request for additional information.

5. The head of the applicant for drug marketing authorization, domestic manufacturer, importer or import entrustor shall issues the decision on voluntary drug recall within 24 hours after the issuing the recall decision.

6. The Minister of Health shall elaborate the procedures for reaching the conclusion that a drug has to be recalled and is involved in a violation to a certain degree, recall of drugs and disposal of recalled drugs.”.

36. Clause 2 of Article 74 is amended as follows:

“2. The Minister of Health shall elaborate prescriptions, drug prescription, application of information technology to drug prescription, sale of prescription drugs and connection of data with the pharmacy information system in the national health database.”.

37. Several points and clauses of Article 76 are amended as follows:

a) Clause 1 is amended as follows:

“1. Drug information is meant to provide medical practitioners, pharmacy practitioners and drug users with instructions on how to use the drug reasonably, safely, and effectively.”;

b) Point a of clause 5 is amended as follows:

“a) Information for medical practitioners and pharmacy practitioners: the drug name, composition, contents, concentrations, dosage form, indications, contraindications, dosage, route of administration, use of the drug in special cases, warnings, drug safety information, and other necessary information;”;

c) Point d is added after point c of clause 5 as follows:

“d) Content of drug information must not contain any information or image not directly related to the drug or use of the drug.”;

d) Point b of clause 6 is amended as follows:

“b) Pharmacy business establishments, representative offices of foreign traders engaged in pharmacy in Vietnam and applicants for drug marketing authorization shall provide drug information in conformity with the documents specified in clause 3 of this Article for medical practitioners, drug users and pharmacy practitioners.

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

dd) Point dd is added after point d of clause 6 as follows:

“dd) The organizations and individuals specified in points a, b and c of this clause shall only provide information on the drugs granted the marketing authorization in Vietnam.”.

38. Clause 2 of Article 78 is amended as follows:

“2. The Minister of Health shall organize a system of drug information and pharmacovigilance; specify the forms and methods of providing drug information.”.

39. Clause 3 of Article 79 is amended as follows:

“3. The Government shall elaborate drug advertisement contents, documentation, procedures for receiving, verifying, and certifying drug advertisement contents; define responsibilities of organizations and individuals advertising and participate in advertising drugs.”.

40. Several clauses of Article 87 are amended as follows:

a) Clause 1 is amended as follows:

“1. Phase 1, 2, and 3 clinical trials shall be carried out before obtaining drug marketing authorization, except for the regulation in clause 1a of this Article.”;

b) Clause 1a is added after clause 1 as follows:

“1a. In order to meet the needs for prevention and treatment of any group A infectious disease that causes an epidemic to be declared in accordance with regulations of law on prevention and control of infectious diseases, the Minister of Health shall decide to grant the marketing authorization to the drug which is undergoing a clinical trial but still has its safety and efficacy monitored and its users, quantity and scope controlled after being granted the marketing authorization if the following requirements are satisfied:

a) Phase 3 interim assessment result for safety and treatment effectiveness of the drug or protection effectiveness of the vaccine based on immunogenicity data approved by the National Research Ethics Committee is available;

b) Consent of the Marketing Authorization Advisory Board is obtained.”.

41. Point b clause 3 of Article 89 is amended as follows:

“c) Any herbal drug has been granted a marketing authorization before January 01, 2017.”.

42. Article 103 is amended as follows:

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

1. Drugs, medicinal materials and primary packages of drugs shall be tested by taking samples, considering technical standards, run relevant and necessary tests to determine whether they meet quality standards.

2. Drugs, medicinal materials and primary packages of drugs must be tested according to the following regulations:

a) Medicinal materials and primary packages of drugs must be tested by the drug manufacturer and meet quality standards before their manufacture is commenced;

b) Finished drugs, medicinal materials and primary packages of drugs must be tested by their manufacturers and meet quality standards before being released;

c) Manufacturers of drugs and medicinal materials are allowed to apply quality management measures that meet Good Manufacturing Practices for drugs and medicinal materials to replace one or more tests for the inspection and determination of the quality of and medicinal materials specified in points a and b of this clause.

3. Apart from the test specified in clause 2 of this Article, the following drugs must also be tested by a testing facility appointed by a competent authority before they are marketed:

a) Vaccines;

b) Biologicals that are antisera;

c) Other drugs specified by the Minister of Health according to result of assessment of risks to drug quality and developments of quality of manufactured and imported drugs.

4. Vaccines and biologicals that are antisera to be tested as prescribed in clause 3 of this Article shall be exempted from one or more or all of the tests in the process of testing conducted at an appointed testing facility in any of the following cases:

a) They are imported from a country with which Vietnam signs a mutual recognition agreement on drug testing laboratories and drug testing results or Vietnam recognizes and acknowledges the drug quality assessment results given by a competent authority on the issuance of quality certificates or release certificates of the exporting country;

b) It is needed to meet urgent needs for national defense and security, disaster recovery, disease prevention and control or special treatment needs;

c) The results of assessment of risks to drug quality and assessment of drug quality trend under regulations of the Ministry of Health prove that the drug meets quality standards during its production and marketing.

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

43. Article 107 is amended as follows:

“Article 107. Measures for drug price management

1. Bid for supply of drugs in national reserve in compliance with the Law on Bidding and regulations of law on national reserves.

2. Procure drugs through bidding or order placement or assignment to serve National Target Programs, national defense and security, disease prevention and control, or incident and disaster recovery in compliance with regulations of law.

3. Announce and re-announce intended wholesale prices of prescription drugs, except for the case of exemption from announcement prescribed by the Government with regard to domestically manufactured drugs or drugs imported for non-commercial purposes.

4. Comment on intended wholesale price of a drug announced or re-announced in the process of drug marketing as the Ministry of Health finds that:

a) The intended wholesale price is higher than the highest price of the similar drugs announced or re-announced without a comment from the Ministry of Health unless the establishment produces an explanatory report and documents proving the reasonableness of the price fluctuation. In case the content or concentration per dosage unit of the drug for which the intended wholesale price has been fixed is different from that of the similar drugs, price comparison will be made based on equivalent conversion; or

b) The difference between the intended wholesale price of the drug and the successful bid of that drug exceeds the maximum difference prescribed by the Government unless the establishment produces an explanatory report and documents proving the reasonableness of the price fluctuation; or

c) There are no drugs marketed in Vietnam that are similar to the drug for which the intended wholesale price announced or re-announced has been fixed and the price announced or re-announced is higher than the selling price in the country of origin or another country unless the establishment produces an explanatory report and documents proving the reasonableness of the price fluctuation.

5. Declare wholesale and retail prices of drugs on the List of essential drugs in accordance with law on prices.

6. Post wholesale and retail prices of drugs in accordance with law on prices.

7. Stabilize drug prices in accordance with law on prices.

8. Negotiate drug prices in accordance with law on prices.

9. Conduct negotiation on prices of drugs which are to be procured through price negotiation in accordance with law on bidding.

10. Impose limits on retail surplus upon drug retailers within medical examination and treatment facilities.

11. The Government shall elaborate the announcement and re-announcement of intended wholesale prices of prescription drugs, clauses 4 and 10 of this Article.”.

44. Article 109 is amended as follows:

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

The Ministry of Health shall preside over and cooperate with other Ministries, ministerial agencies, Governmental agencies and People’s Committees of provinces in state management of drug prices and shall undertake the following tasks:

1. Preside over formulating, promulgate within its power or request competent authorities to promulgate legislative documents on drug prices and organize the implementation of policies and laws on drug prices;

2. Request other Ministries, ministerial agencies, Governmental agencies and People’s Committees of provinces to submit periodic and ad hoc reports on management of drug prices;

3. Preside over organizing dissemination and education of laws on drug prices;

4. Take measures for drug price stabilization in accordance with law on prices;

5. Organize receipt of and review information on dossiers on announcement and re-announcement of intended wholesale prices of drugs and publish intended wholesale prices of drugs on its web portal within 07 working days from the date of receiving sufficient dossiers;

6. Publish its comments on intended wholesale drug prices announced and re-announced as prescribed in clause 4 Article 107 of this Law;

7. Carry out examination and inspection, and impose penalties for violations of law on drug prices.”.

45. Article 110 is amended as follows:

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

Exercise its functions of state management of drug prices in accordance with law on prices.”.

46. Clause 3 of Article 112 is amended as follows:

“3. Organize receipt of dossiers on drug prices declared and re-declared by local drug business establishments and update information and data on declared drug prices to the national price database in accordance with law on prices.”.

47. Article 113 is amended as follows:

“Article 113. Responsibility of Vietnam Social Security for state management of drug prices

Publish successful bids of drugs covered by the health insurance fund on the website of Vietnam Social Security.”.

48. Phrases in some points and clauses below are replaced and removed:

a) The phrase “thuốc thuộc Danh mục thuốc phải kiểm soát đặc biệt và Danh mục thuốc hạn chế bán lẻ” (“drugs on the List of controlled drugs and List of drugs restricted from retailing”) in point b clause 1 of Article 47 and point b clause 1 of Article 49 is replaced with the phrase “thuốc phải kiểm soát đặc biệt và thuốc thuộc Danh mục thuốc hạn chế bán lẻ” (“controlled drugs and drugs on the List of drugs restricted from retailing”);

b) The phrase “m và n khoản 2 Điều 42 của Luật này” (“m and n clause 2 Article 42 of this Law”) in 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 is replaced with the phrase “m, n và q khoản 2 Điều 42 của Luật này” (“m, n and q clause 2 Artile 42 of this Law”).

c) The phrase “Bản sao có chứng thực” (“Certified true copy”) are removed from clause 2 of Article 24, points c and d clause 1, points c and d clause 2 and points b and c clause 4 of Article 38;

d) The phrase “Bản sao” (“Copy”) are removed from clause 2 of Article 25, and clauses 2 and 3 of Article 26.

49. Clause 6 of Article 24, clause 3 of Article 78, point b clause 1 and point b clause 2 of Article 89, and Article 114 are repealed.

Article 2. Amendments to the Law on Prices No. 16/2023/QH15

Section 9 of the Appendix 01 - List of goods and services subject to price stabilization promulgated together with the Law on Prices No. 16/2023/QH15 is amended as follows:

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

Article 3. Implementation clause

1. This Law comes into force from July 01, 2025, except for the case specified in clause 2 of this Article.

2. The following regulations come into force from 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 renewal of marketing authorizations of drugs and medicinal materials specified in clause 30 Article 1 of this Law.

3. Transitional clauses:

a) Applications for issuance or revision of marketing authorization of drug or medicinal material and applications for certification or adjustment of content of drug information which are submitted before July 01, 2025 but are yet to be processed shall be processed as per regulations of the Law on Pharmacy No. 105/2016/QH13 amended by the Law No. 28/2018/QH14 unless the applicant requests the application of this Law;

b) The declared or re-declared drug price as prescribed in clause 3 Article 107 of the Law on Pharmacy No. 105/2016/QH13 amended by the Law No. 28/2018/QH14 shall continue to apply and be treated as the announced or re-announced intended wholesale price as prescribed in this Law.

This Law is adopted by the 15th National Assembly of Socialist Republic of Vietnam on this 21^st of November 2024 during its 8^th session.

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