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^[1]

Pursuant to the Constitution of the Socialist Republic of Vietnam;

The National Assembly promulgates the Law Amending and Supplementing a Number of Articles of Law No. 105/2016/QH13 on Pharmacy, which has a number of articles amended and supplemented under Law No. 28/2028/QH14.

Article 1. To amend and supplement 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 also traditional medicaments) means drug materials which are derived from plants, animals, minerals or fungus and satisfy drug manufacturing standards.”;

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

“8. Traditional drug means a drug composed of one or more than one medicinal material that is/are blended according to traditional medicine theories or folk experiences and processed and prepared by traditional medicine methods into a product with a traditional or modern preparation form.

9. Traditional medicaments means medicinal materials preliminarily processed or processed according to traditional medicine theories or folk experiences to manufacture or prepare traditional drugs.

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

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

c/ To amend and supplement Clauses 17, 18 and 19 as follows:

“17. Addictive drug means a drug containing pharmaceutical ingredients with neural stimulation or inhibition effects which can easily induce a state of addiction to users, and included in the Minister of Health-promulgated List of addictive pharmaceutical ingredients, except combination drugs containing addictive pharmaceutical ingredients specified in Clause 20 of this Article.   

18. Psychotropic drug means a drug containing pharmaceutical ingredients with neural stimulation or inhibition effects or causing hallucination, likely to induce a state of addiction to users when used consistently, and included in the Minister of Health-promulgated List of psychotropic pharmaceutical ingredients, except combination drugs containing psychotropic pharmaceutical ingredients specified in Clause 21 of this Article.   

19. Precursor drug means a drug containing a precursor included in the Minister of Health-promulgated List of precursors used as drugs, except combination drugs containing precursors specified in Clause 22 of this Article.”;   

d/ To amend and supplement Clause 27 as follows:

“27. Non-prescription drug means a drug that can be dispensed, retailed and used without a prescription, identified on the principles and criteria promulgated by the Minister of Health, and is included in the Ministry of Health-announced List of non-prescription drugs.”;

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 and retailing of drugs and drug materials; prescription of drugs and clinical trial of drugs; and agricultural and collection practices, 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 below Clause 43 as follows:

“44. Projected drug wholesale price means the maximum wholesale price determined by a drug importer or drug manufacturer before wholesaling the first drug batch to the market; Wholesale prices applied by drug traders may not be higher than such maximum wholesale price.

45. Declaration of projected drug wholesale price means the sending of a notice of a projected drug wholesale price by a drug importer or drug manufacturer to the Ministry of Health before selling the first drug batch to the market for announcement on the Ministry of Health’s Portal.

46. Re-declaration of projected drug wholesale price means the sending of a notice of a projected drug wholesale price by a drug importer or drug manufacturer to the Ministry of Health upon the occurrence of a change in the declared drug wholesale price for announcement on the Ministry of Health’s Portal.

47. Similar drug items means drugs with the same pharmaceutical ingredients, medicinal materials, preparation form and technical specifications.

48. Drugstore chain means a system of drugstores of a drugstore chain-organizing establishment that operates under the uniform quality management system and the same trade name.

49. Inferior-quality drug material means a drug material that fails to meet the quality standards registered or declared to a competent state agency.

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

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 under regulations of the Government.”.

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 registered business location stated in the certificate of eligibility for pharmaceutical business or licensed by a competent state agency, except e-commerce activities.”;

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

“i/ Wholesaling a prescription drug at a price higher than its declared or re-declared wholesale price; wholesaling or retailing a drug at a price higher than its posted price.”;

c/ To amend and supplement Clause 8 as follows:

“8. Practicing based on job positions specified in Article 11 of this Law without a pharmacy practice certificate or beyond the scope of professional operation stated in a pharmacy practice certificate, or practicing while being deprived of the right to use a pharmacy practice certificate.”;

d/ To add Clauses 17, 18 and 19 below Clause 16 as follows:

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

a/ Prescription drugs, except cases of medical isolation to fight a group-A infectious disease which is declared as an epidemic in accordance with the law on infectious disease prevention and control;

b/ Drugs subject to special control;

c/ Drugs on the List of drugs subject to limited retail.

18. Wholesaling drugs subject to special control by e-commerce methods.

19. Trading in drugs and drug materials by e-commerce methods via means other than e-commerce exchanges, e-commerce applications, or websites (also known as e-commerce websites) with the function of online order placement.”.

4. To amend and supplement Article 7 as follows:

“Article 7. The State’s 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, remediation of consequences of incidents, disasters and catastrophes, and epidemic prevention and control.

2. To ensure the rational, safe and effective use of drugs; to develop clinical pharmacy and pharmacovigilance.

3. To provide incentives and support for development of the pharmaceutical industry into a spearhead industry.

4. For drugs to be purchased with state budget funds and other lawful revenues of public medical establishments, the relevant provisions of the bidding law and regulations on incentives for drug purchase shall be implemented for:

a/ Drugs domestically researched and manufactured from domestic materials, brand-name drugs with technologies transferred in Vietnam; first domestically manufactured generic drugs and first domestically manufactured similar biologicals;

b/ Drugs from medicinal materials and traditional drugs that are manufactured from domestic medicinal materials satisfying good agricultural and collection practices;

c/ Drugs from medicinal materials and traditional drugs that are manufactured under national-, ministerial- or provincial-level scientific and technological tasks and have undergone acceptance testing;

d/ Drugs on the Prime Minister-approved List of national products.

5. To give the following priorities in terms of administrative procedures:

a/ Regarding order, procedures and time limit for grant of certificates of registration for circulation of drugs and drug materials for new drugs; brand-name drugs; rare drugs; vaccines; first domestically manufactured generic drugs; first domestically manufactured similar biologicals; hi-tech drugs; drugs having undergone clinical trials in Vietnam; drugs manufactured from medicinal materials satisfying good agricultural and collection practices; drugs and drug materials manufactured on the basis of national-level scientific and technological tasks and having undergone acceptance testing; and drugs serving requirements of national defense and security and remediation of consequences of incidents, disasters and catastrophes, and epidemic prevention and control;

b/ Regarding criteria, order, procedures and time limit for grant of import permits for new drugs; rare drugs; vaccines having undergone prequalification by the World Health Organization; hi-tech drugs; drugs having undergone clinical trials in Vietnam; and drugs serving requirements of national defense and security and remediation of consequences of incidents, disasters and catastrophes, and epidemic prevention and control.

6. To apply mechanisms for provision of incentives and support from the National Technology Innovation Foundation, the National Foundation for Science and Technology Development, the National Hi-Tech Venture Fund, and other foundations/funds to provide support for scientific and technological activities in the following cases:

a/ Research, development, clinical trial, technology transfer, manufacture and commercialization of drug materials, new drugs, vaccines, biologicals, hi-tech drugs, first domestically manufactured generic drugs, traditional drugs in modern preparation forms, and drugs from medicinal materials manufactured on the basis of national- and ministerial-level scientific and technological tasks;

b/ Investment in establishment and development of clinical trial centers in the development of new drugs, bioequivalence trials, biosimilar trials.

7. To use the state budget’s investment together with  other mobilized resources for the development of the industry of manufacture of vaccines, biologicals, drugs from medicinal materials and traditional drugs, drugs manufactured from domestic medicinal materials, and first domestically manufactured generic drugs; for agricultural and manufacturing practices; discovery, conservation, and application of science and technology to the research and development, of genetic resources of precious, rare and endemic medicinal materials.

8. To support and facilitate the discovery, clinical trial and registration for circulation and protection of related intellectual property rights and takeover of traditional drugs and drugs from medicinal materials manufactured on the basis of national-, ministerial- or provincial-level scientific and technological tasks having undergone acceptance testing; to search, exploit and use new medicinal materials; to export medicinal materials from agricultural practices; to acclimatize medicinal materials; to rationally exploit natural medicinal materials; to research, survey and investigate appropriate medicinal material species for agricultural practices in localities; to develop areas for agricultural practices; to modernize the manufacture of medicinal materials, and adopt policies to promote the export of drugs from medicinal materials and traditional drugs.

9. To keep secrets 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 owners of folk remedies recognized by the Ministry of Health.

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

To provide incentives and support for the development of the drug supply system and mobile pharmacies in areas inhabited by ethnic minority people, mountainous areas, islands, 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 and military-cum-people’s medical examination and treatment establishments to participate in the supply of drugs and agricultural practices in order to meet the people’s disease prevention and treatment needs in areas inhabited by ethnic minority people, mountainous areas, islands, areas with difficult socio-economic conditions, and areas with extremely difficult socio-economic conditions.

12. To improve the quality of pharmaceutical human resources, support the training of high-quality human resources for research, development, receipt of transferred technology, manufacture and trial of new drugs, brand-name drugs, hi-tech drugs, drugs from medicinal materials, and traditional drugs.

13. To keep stable prices or reduce prices for new drugs, brand-name drugs, hi-tech drugs, vaccines, and rare drugs with manufacture technologies transferred in Vietnam.

14. To control the number of drug circulation registration certificates for drugs with the same pharmaceutical ingredients or medicinal materials in conformity with socio-economic conditions in each period.

15. To prioritize investment in the development of information technology infrastructure and digital transformation in pharmaceutical activities.

16. The Government shall detail this Article.”.

5. To amend and supplement Article 8 as follows:

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

1. Investment incentive and support policies shall be implemented for investment projects in the field of pharmacy in accordance with the investment law.

2. A new investment project (including also expansion of such project) in the development of the pharmaceutical industry with a total investment capital of VND 3 trillion or more and with at least VND 1 trillion expected to be disbursed within 3 years from the date of grant of an investment registration certificate or investment policy approval is entitled to special investment incentives and support as for the project specified at Point a, Clause 2, Article 20 of the Investment Law, covering:

a/ Technology research and development, production or technology transfer for manufacture of drugs from medicinal materials and traditional drugs from domestic medicinal materials, pharmaceutical ingredients, new drugs, brand-name drugs, rare drugs, first domestically manufactured generic drugs, hi-tech drugs, vaccines, and biologicals;

b/ Agricultural practices in areas with difficult socio-economic conditions or areas with extremely difficult socio-economic conditions;

c/ Research for conservation and development of genetic resources of precious, rare and endemic medicinal materials at home; creation of new varieties from genetic resources of medicinal materials of high economic value.

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 to serve the state management and selection and creation of varieties and breeds, and agricultural and collection practices; widely applying techniques of agricultural practices of, and prevention and control of diseases and pests on, medicinal plants and animals;”;

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

“a/ Propose competent authorities to allocate or allocate according to its competence money amounts for implementation of plans and programs on development of the pharmaceutical industry in accordance with the Law on the 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, 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 Ministry of Health in, organizing research and conservation of genetic resources of precious, rare and endemic medicinal materials; researching, selecting and creating species and breeds, carrying out agricultural practices, and preventing and controlling diseases and pests on medicinal plants and animals, and collecting medicinal materials;

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

d/ Assume the prime responsibility for, and coordinate with related ministries and ministerial-level agencies in, formulating mechanisms and policies on application of science and technology for development of the chemico-pharmaceutical industry.”;

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

“b/ Allocate land areas for building of pharmaceutical factories and industrial zones, projects on development of medicinal material zones and material zone 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.

A revoked pharmacy practice certificate may be re-granted after 24 months since the date of revocation, for the cases specified in Clause 4, 6, 10 and 11, Article 28 of this Law.”.

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

“Article 17a. Conditions on persons in charge of professional pharmacy activities of drugstore chain-organizing establishments and drugstores in drugstore chains

1. A person in charge of professional pharmacy activities of a drugstore chain-organizing establishment must possess a professional degree specified at Point a, Clause 1, Article 13 of this Law and have 2 years’ practice experience at an appropriate pharmacy establishment.

2. A person in charge of professional pharmacy activities of each drugstore in a drugstore chain must satisfy the conditions specified in Clause 1, Article 18 of this Law.”.

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

“7. A criminal records certificate of the applicant, unless the database on criminal records certificates is updated and shared to the dossier-receiving agency in accordance with regulations of the Government.

For a foreigner or an overseas Vietnamese, the dossier must comprise a criminal records certificate or a letter of confirmation 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 pharmaceutical activities under a court judgment or ruling issued by a foreign authority.”.

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

“8. The pharmacy practice certificate holder has not carried out any activities within the scope of professional activities stated in his/her pharmacy practice 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 establishment and at only one pharmaceutical business location, except the case specified in Clause 3a of this Article.”;

b/ To add Clause 3a below Clause 3 as follows:

“3a. A person in charge of professional pharmacy activities of a drugstore chain-organizing establishment shall take the general charge of professional pharmacy activities of such drugstore chain.”.

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 and drug materials, including also trading in drugs and drug materials by e-commerce methods on e-commerce exchanges, e-commerce applications, and e-commerce websites with the function of online order placement;”;

b/ To add Point i below Point h, Clause 2 as follows:

“i/ Drugstore chain-organizing establishments.”.

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

“h/ A drugstore chain-organizing establishment must satisfy the conditions specified at Point c of this Clause, have 2 or more attached drugstores for which certificates of eligibility for pharmaceutical business have been granted, and have a uniform quality management system for application to drugstores in the chains.”.

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

“d/ Medical establishments of the people’s armed forces and military-cum-people’s medical examination and treatment establishments engaged in the supply of drugs in ethnic minority areas, mountainous areas, on islands, and in areas with difficult socio-economic conditions or 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 of a pharmaceutical business establishment shall be modified in the following cases:

a/ There is a change in the name or business address of the establishment;

b/ There is a change in the scope of pharmaceutical business without any change in pharmaceutical business conditions;

c/ There is a change in information about the person in charge of professional pharmacy activities stated in the certificate of eligibility for pharmaceutical business, except the case of rotation of such person between drugstores in the drugstore 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 for the pharmaceutical 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 below Point d, Clause 1 as follows:

“dd/ The list of drugstores in drugstore chains for which certificates of eligibility for pharmaceutical business have been granted by the time of dossier submission, for drugstore chain-organizing establishments.”;

b/ To add Point dd below Point d, Clause 2 as follows:

“dd/ The list of drugstores in drugstore chains for which certificates of eligibility for pharmaceutical business have been granted by the time of dossier submission, for drugstore chain-organizing establishments.”.

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

a/ To amend and supplement Point dd and add Point e below Point dd, Clause 1 as follows:

“dd/ To organize mobile pharmacies in ethnic minority areas, mountainous areas, on islands, and in areas with difficult socio-economic conditions or areas with extremely difficult socio-economic conditions under regulations of the Government;

e/ To buy and sell prescription drugs from the date the Ministry of Health receives dossiers for declaration or re-declaration of projected drug wholesale prices from drug manufacturers or drug importers.”;

b/ To add Point q below Point p, Clause 2 as follows:

“q/ To take responsibility before law for the accuracy, legality and truthfulness of dossiers and documents provided to competent agencies.”;

c/ To add Clause 4 below 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 by e-ecommerce methods, pharmaceutical business establishments have the following rights and responsibilities:

a/ To comply with the laws on e-transactions, e-commerce, advertising, and protection of consumers’ interests, and relevant regulations;

b/ To ensure confidentiality of buyer information in accordance with law;

c/ To publish adequate information about certificates of eligibility for pharmaceutical business, or pharmacy practice certificates of persons in charge of professional pharmacy activities of establishments, and information about drugs that is approved under regulations of the Government;

d/ To notify the pharmaceutical business by e-commerce methods to competent agencies under regulations of the Minister of Health;

dd/ Drug retailers shall provide online counselling and instructions on drug use to drug buyers, and organize delivery of drugs to buyers under regulations of the Minister of Health;

e/ To retail only non-prescription drugs other than drugs subject to special control and those on the List of drugs subject to limited retail.

To retail prescription drugs under regulations of the Minister of Health in case of medical isolation upon the occurrence of a group-A infectious disease which is declared as an epidemic in accordance with the law on infectious disease prevention and control;

g/ To wholesale drugs and drug materials other than drugs subject to special control;

h/ To comply with other the Government’s regulations on wholesale of drugs and drug materials and retail of drugs by e-commerce methods.”.

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:

“a/ To wholesale drugs and drug materials manufactured by themselves to medical examination and treatment establishments, vaccination establishments and other health establishments; drug rehabilitation establishments; state-owned drug and drug material testing establishments; science and technology organizations and training institutions engaged in research and training activities related to pharmacy; pharmaceutical business establishments specified in Clause 2, Article 32 of this Law; establishments that have been granted investment registration certificates for drug manufacture but have not yet been granted certificates of eligibility for pharmaceutical business for trial manufacture and assessment of drug production processes;”;

b/ To add Point e below Point dd, Clause 2 as follows:

“e/ To declare or re-declare projected drug wholesale prices 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 provided at 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 drugs and drug materials imported by themselves to medical examination and treatment establishments, vaccination establishments and other health establishments; drug rehabilitation establishments; state-owned drug and drug material testing establishments; science and technology organizations and training institutions engaged in research and training activities related to pharmacy; pharmaceutical business establishments specified in Clause 2, Article 32 of this Law; establishments that have been granted investment registration certificates for drug manufacture but have not yet been granted certificates of eligibility for pharmaceutical business for trial manufacture and assessment of drug production processes;”;

c/ To add Point c below Point b, Clause 2 as follows:

“c/ To declare or re-declare projected drug wholesale prices 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 and drug materials to medical examination and treatment establishments, vaccination establishments and other health establishments; drug rehabilitation establishments; state-owned drug and drug material trial establishments; science and technology organizations and training institutions engaged in research and training activities related to pharmacy; pharmaceutical business establishments specified in Clause 2, Article 32 of this Law; establishments that have been granted investment registration certificates for drug manufacture but have not yet been granted certificates of eligibility for pharmaceutical business for trial manufacture and assessment of drug production processes;”;

b/ To add Point c below Point b, Clause 2 as follows:

“c/ To declare drug wholesale prices under Clause 5, Article 107 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 buy drug materials for preparing prescription drugs and sell these drugs at drugstores or the right provided at Point b, Clause 3, Article 47a of this Law. Persons in charge of professional pharmacy activities of drugstores shall directly manage the drug preparation at drugstores;”;

b/ To add Point d below Point c, Clause 2 as follows:

“d/ To declare drug retail prices under Clause 5, Article 107 this Law.”.

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

“Article 47a. Rights and responsibilities of drugstore chain-organizing establishments and drugstores in drugstore chains

1. Drugstore chain-organizing establishments have the following rights:

a/ The rights provided in Clause 1, Article 42 of this Law;

b/ To buy drug materials for transfer to drugstores in their drugstore chains for preparation of prescription drugs and sell these drugs right at such drugstores;

c/ To buy drugs for transfer to drugstores in their drugstore chains for retail, except vaccines. In case of buying drugs subject to special control and drugs on the List of drugs subject to limited retail, they shall comply with Article 34 of this Law;

d/ To rotate drugs between their drug preservation stores and drugstores and among drugstores in their drugstore chains, except drugs prepared according to prescriptions. The rotation of drugs shall be coordinated by persons in charge of their professional pharmacy activities;

dd/ To rotate persons in charge of professional pharmacy activities of drugstores in their drugstore chains.

2. Drugstore chain-organizing establishments have the following responsibilities:

a/ The 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 build quality management systems of their drugstore chains, covering organizational structure, processes, human resources, files and documents, information system, management system, physical and technical facilities and systematic activities, satisfaction of requirements on good practices in conformity with their business scope;

c/ To manage all activities related to the supply, circulation and preservation of drugs and drug materials and customer-related data at all drugstores in their drugstore chains by uniform processes;

d/ To supply all drugs and drug materials to drugstores in their drugstore chains;

dd/ To take the total responsibility for activities of drugstores in their drugstore chains;

e/ To send reports to the Ministry of Health and provincial-level Departments of Health of localities where drugstores in their drugstore chains operate, and perform the law-specified obligations in case such drugstores have ceased their operation for 6 months or more or terminate their operation;

g/ To implement the Minister of Health’s regulations on notification or updating to competent agencies the lists of drugstores in their drugstore chains; lists of persons possessing pharmacy practice certificates who currently practice at their establishments and at drugstores in their drugstore chains; and the rotation of persons in charge of professional pharmacy activities among drugstores in their drugstore chains;

h/ To send annual reports and reports upon requests of the state management agency in charge of pharmacy on their activities and activities of drugstores in their drugstore chains; to notify to the Ministry of Health within 3 working days after a drugstore in their drugstore chains is administratively handled in the field of pharmacy.

3. Drugstores in drugstore chains have the following rights:

a/ The rights provided at Points a, d and dd, Clause 1, Article 47 of this Law;

b/ To receive drug materials from drugstore chain-organizing establishments for preparation of prescription drugs and sell these drugs. Persons in charge of their professional pharmacy activities shall directly manage the drug preparation at drugstores;

c/ To receive drugs from drugstore chain-organizing establishments for retail; in case of sale of drugs subject to special control and drugs on the List of drugs subject to limited retail, they shall comply with Article 34 of this Law.

4. Drugstores in drugstore chains have the following responsibilities:

a/ The 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; and Clause 2, Article 81, of this Law;

b/ To trade only in drugs supplied by the drugstore chain-organizing establishments;

c/ To comply with quality management systems built by the drugstore chain-organizing establishments;

d/ To suspend their operation in case the drugstore chain-organizing establishments have suspended their operation for 6 months or more;

dd/ To terminate their operation when the drugstore chain-organizing establishments terminate their operation.”.

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

“c/ To declare drug retail prices under Clause 5, Article 107 of this Law.”.

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

“c/ To declare drug retail prices under Clause 5, Article 107 of this Law.”.

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

“c/ To declare retail prices of drugs from medicinal materials and of traditional drugs under Clause 5, Article 107 of this Law.”.

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

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

1. Pharmaceutical business establishments specified at Points a, b, e, g and h, Clause 2, Article 32 of this Law that are foreign-invested ones have the following rights:

a/ The rights provided at Points b, c and d, Clause 1, Article 42 of this Law;

b/ The rights corresponding to their types 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; and Points b, c, d and dd, Clause 1, Article 53, of this Law.

2. Foreign-invested drug and drug material manufacture establishments have the rights provided in Clause 1 of this Article and the following rights:

a/ To wholesale, forward and transport drugs and drug materials manufactured by themselves or processed under orders placed by themselves or manufactured with technologies transferred in Vietnam to medical examination and treatment establishments, vaccination establishments and other health establishments; drug rehabilitation establishments; state-owned drug and drug material testing establishments; science and technology organizations and training institutions engaged in pharmacy-related research and teaching activities; pharmaceutical business establishments specified in Clause 2, Article 32 of this Law; establishments that have been granted investment registration certificates for drug manufacture but have not yet been granted certificates of eligibility for pharmaceutical business for trial manufacture and assessment of drug production processes.  

In case of sale of prescription drugs, they may sell drugs from the date the Ministry of Health receives dossiers for declaration or re-declaration of projected drug wholesale prices;

b/ To forward and transport drugs under donation, aid, humanitarian aid or disease prevention and control programs to aid-receiving health establishments.

3. Foreign-invested drug and drug material-importing establishments have the rights provided in Clause 1 of this Article and the following rights:

a/ To wholesale drugs and drug materials imported by themselves to establishments wholesaling drugs and drug materials. In case of sale of prescription drugs, they may sell drugs from the date the Ministry of Health receives dossiers for declaration or re-declaration of projected drug wholesale prices;

b/ To buy drugs and drug materials manufactured with technologies transferred by themselves in Vietnam; to sell drugs and drug materials manufactured under orders placed or with technologies transferred by themselves in Vietnam to establishments wholesaling drugs and drug materials;

c/ To import drug materials within the scope stated in their certificates of eligibility for pharmaceutical business for supply to drug manufacture establishments for manufacture/processing under orders placed or with technologies transferred by themselves in Vietnam under processing contracts or technology transfer contracts;

d/ To forward and transfer drugs and drug materials imported by themselves or manufactured under orders placed or with technologies transferred by themselves in Vietnam from their drug and drug material preservation stores to establishments wholesaling drugs and drug materials;

dd/ To forward and transport drugs under donation, aid, humanitarian aid or disease prevention and control programs to aid-receiving health establishments;

e/ To transport drug materials imported by themselves from their drug material preservation stores to drug manufacture establishments for manufacture/processing under orders placed or with technologies transferred by themselves in Vietnam under processing contracts or technology transfer contracts; to transport drugs for use in clinical trial with donations provided and imported by themselves to establishments receiving drugs for clinical trial.

4. Pharmaceutical business establishments specified at Points a, b, e, g and h, Clause 2, Article 32 that are foreign-invested ones have the responsibilities corresponding to their types specified in Clause 2, Article 42; Clause 2, Article 43; Clause 2, Article 44; Clause 2, Article 51; Clause 2, Article 52; and Clause 2, Article 53, of this Law, and may not carry out activities directly related to the distribution of drugs and drug materials, including:

a/ Selling, forwarding and transporting drugs and drug materials, except the cases specified in Clauses 2 and 3 of this Article;

b/ Receiving for preservation drugs and drug materials neither imported nor manufactured/processed under orders or with technologies transferred by themselves in Vietnam;

c/ Receiving orders or undertaking to make payment for drugs and drug materials of medical examination and treatment establishments, retailers, individuals and organizations other than drug and drug material wholesalers, except the case specified in Clause 2 of this Article;

d/ Determining or imposing selling prices of drugs and drug materials distributed by other pharmaceutical business establishments, except the case of implementation of this Law’s provisions on drug price management;

dd/ Deciding on strategies for distribution and policies on trading in drugs and drug materials distributed by other pharmaceutical business establishments;

e/ Formulating plans on supply of drugs and drug materials of medical examination and treatment establishments in Vietnam;

g/ Providing financial support in any forms to organizations and individuals that directly buy their drugs and drug materials for the purpose of manipulating the distribution of imported drugs and drug materials.

5. Foreign-invested pharmaceutical business establishments may neither retail nor wholesale drugs and drug materials, except the cases specified in Clauses 2 and 3 of this Article.”.

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

“b/ Imported drugs specified in Clauses 2 and 5a, Article 60 of this Law;”.

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

“b/ Drugs for which circulation registration certificates have been granted but later see changes in their pharmaceutical ingredients or medicinal materials; content, concentration or amount of pharmaceutical ingredients or medicinal materials per dose; forms of preparation; or manufacturers, except change of packaging establishments or manufacturing workshops or locations;

c/ Drug materials for which circulation registration certificates have been granted but later see changes in their manufacturers , except change of packaging establishments or manufacturing workshops or locations.”.

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 certificates of registration for circulation of drugs and drug materials

1. The Ministry of Health shall grant, extend or modify and supplement certificates of registration for circulation of drugs and drug materials on the basis of dossier appraisal and advices from the Advisory Council for grant of certificates of registration for circulation of drugs and drug materials, except the case specified at Point b, Clause 9 of this Article.

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

a/ Information on the grant, extension and modification and supplementation of certificates of registration for circulation of drugs and drug materials;

b/ Cases specified at Point c, Clause 8 of this Article;

c/ Non-prescription drugs after obtaining certificates of registration for circulation of drugs.

3. A dossier of request for grant of a certificate of registration for circulation of drugs and drug materials must comprise:

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

In case to satisfy requirements of the prevention and treatment of group-A infectious diseases that have been declared as epidemics in accordance with the law on prevention and control of infectious diseases, the certificate of pharmaceutical products may be replaced by another document issued by a competent agency which certifies drugs to be circulated and used in the host country and fully shows information on the name and address of the manufacturer, and conditions for being licensed;

b/ Technical documents proving that drugs and drug materials satisfy the requirements specified in Clause 4, Article 54 of this Law; for new drugs, reference biologicals and vaccines, clinical trial documents proving their safety and efficacy are also required; for similar biologicals, documents proving the similarity in their quality, safety and efficacy compared to a reference biological are also required; for drugs subject to bioequivalence testing, a report on their bioequivalence study data is also required; in case the applicant wishes to apply the form of reference of drug registration dossier appraisal results, documents on appraisal results of the Stringent Regulatory Authority (SRA) or pharmaceuticals management agency recognized by the Ministry of Health based on the World Health Organization’s classification are also required.

For domestically manufactured new drugs (excluding vaccines) for use in the prevention and treatment of group-A infectious diseases that have been declared as epidemics in accordance with the law on prevention and control of infectious diseases and have the same active ingredients, preparation form, route of administration and indications for drugs that have been licensed for circulation or licensed for use in cases of emergency or licensed for circulation and conditional use by one of the Stringent Regulatory Authorities (SRA) or the pharmaceutical management agency recognized by the Ministry of Health based on the World Health Organization’s classification, clinical trial documents are not required;

c/ Actual label samples of drugs and drug materials circulated in the host country or a reference country, for imported drugs.

4. A dossier of request for extension of a certificate of registration for circulation of drugs and drug materials must comprise:

a/ An application for extension of the certificate;

b/ A valid certificate of pharmaceutical products, for imported drugs;

c/ A report on the safety and efficacy of drugs in the course of circulation.

5. A dossier of request for modification and supplementation of a certificate of registration for circulation of drugs and drug materials must comprise:

a/ An application for modification and supplementation of the certificate;

b/ Technical documents, for to-be-modified and supplemented contents;

6. Time limit for grant, extension or modification and supplementation of a certificate of registration for circulation of drugs and drug materials is:

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

b/ Nine months from the date of receipt of a complete dossier specified in Clause 3 of this Article for cases in which the application of the form of reference of appraisal results is required;

c/ Three months from the date of receipt of a complete dossier specified in Clause 4 of this Article;

d/ Three months from the date of receipt of a complete dossier specified in Clause 5 of this Article, except the case specified at Point dd of this Clause;

dd/ Twenty days from the date of receipt of a complete dossier specified in Clause 5 of this Article for cases of modification and supplementation of a certificate of registration for circulation of drugs and drug materials in which the modified and supplemented contents do not affect the quality, safety and efficacy of drugs.

e/ Fifteen days from the date of receipt of a complete dossier as specified in Clause 3 of this Article for dossiers of registration for circulation of new drugs for use in the prevention and treatment of group-A infectious diseases that have been declared as epidemics in accordance with the law on prevention and control of infectious diseases, that have have been licensed for circulation or licensed for use in cases of emergency or licensed for circulation and conditional use by one of the Stringent Regulatory Authorities (SRA) or the pharmaceutical management agency recognized by the Ministry of Health based on the World Health Organization’s classification.

7. The Ministry of Health shall grant, extend or modify and supplement of certificates of registration for circulation of drugs and drug materials within the time limit specified in Clause 6 of this Article; in case of refusal to grant, extend or modify and supplement a certificate of registration for circulation of drugs and drug materials, it shall issue a written reply, clearly stating the reason.

In case a drug has a circulation registration certificate but is not circulated on the market within 5 years from the effective date of the certificate, the certificate may not be extended, except for rare drugs and medicines with no more than 3 drugs of 3 manufacturers that contain the same pharmaceutical ingredients, medicinal materials, preparation form, content or concentration, amount of medicinal materials in a dose and have circulation registration certificates that remain valid.

8. Validity duration of a certificate of registration for circulation of drugs and drug materials is as follows:

a/ Validity duration of a certificate of registration for circulation of drugs and drug materials is 5 years, counted from the date of its grant or extension, except the cases specified at Points b and c of this Clause;

b/ Validity duration of a certificate of registration for circulation is 3 years from the date of its grant or extension for drugs whose safety and efficacy need to be further monitored.

c/ A certificate of registration for circulation of drugs and drug materials that expires with its dossier of request for extension received by the Ministry of Health may continue to be used until it is extended or until the Ministry of Health issues a written refusal of extension or a notice of suspension of use of the certificate as it detects drugs and drug materials are likely to be unsafe for users or suspected of forging of legal documents.

9. The Minister of Health shall specify dossiers for grant, extension or modification and supplementation of certificate of registration for circulation of drugs and drug materials specified in Clauses 3, 4, and 5 of this Article and prescribe the following contents:

a/ Procedures for grant, extension or modification and supplementation of a certificate of registration for circulation of drugs and drug materials;

b/ The case the dossier for extension or modification and supplementation of a certificate of registration for circulation of drugs and drug materials does not require dossier appraisal and advices from the Advisory Council for grant of certificates of registration for circulation of drugs and drug materials based on the assessment of risks related to the quality, safety and efficacy of drugs and drug materials;

c/ The grant of a certificate of registration for circulation of drugs and drug materials for new drugs used for the prevention and treatment of group-A infectious diseases that have been declared as epidemics in accordance with the law on prevention and control of infectious diseases based on the recognition of licensing results by one of the Stringent Regulatory Authorities (SRA) or the pharmaceutical management agency recognized by the Ministry of Health based on the World Health Organization’s classification does neither require appraisal of technical documents nor assessment of the compliance with the Good Manufacturing Practices.”

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

“b/ Imported drugs and drug materials specified 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/ Bioequivalence tests, bioavailability assessment, making of samples for registration or testing or scientific research or display at exhibitions or fairs;

i/ Drugs in other cases for non-commercial purposes, including also cases where drugs are imported by medical examination and treatment establishments to meet their patients’ special treatment requirements.”;

b/ To amend and supplement Clause 3 as follows:

3. Drug materials without certificates of registration for circulation in Vietnam may be imported in quantities not exceeding those stated in their import permits in the following cases:

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

b/ For manufacturing of drugs for export, semi-finished drugs for export, drugs for national defense and security, drugs for prevention and treatment of group-A infectious diseases that have been declared as epidemics in accordance with the law on prevention and control of infectious diseases, or remediation of consequences of incidents, disasters or catastrophes; manufacturing and preparation of drugs to meet treatment requirements of medical examination and treatment establishments.”;

c/ To add Clauses 5a and 5b below Clause 5 as follows:

“5a. Drugs without certificates of registration for circulation in Vietnam for use for clinical trial may be imported without import permits in quantities and of types posted on the Ministry of Health’s portal based on written explanations about research outlines of clinical trials approved by the Ministry of Health, excluding drugs specified 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 manufacturing drugs that have certificates of registration for circulation to be used in the prevention and treatment of group A infectious diseases that have been declared as epidemics in accordance with the law on prevention and control of infectious diseases, for pharmaceutical ingredients and medicinal materials that have been permitted for import for other purposes.”;

d/ To add Clause 6a below Clause 6 as follows:

“6a. The Ministry of Finance shall periodically share information with the Ministry of Health on data on drugs subject to special control that have been cleared from customs procedures for export and import under the Government’s regulations.”;

dd/ To amend and supplement Clause 7 as follows:

“7. The Government shall specify the following contents:

a/ Criteria, dossiers, procedures and time limit for grant and revocation of import permits and export permits for drugs and drug materials specified in Clauses 2, 3, 4 and 5 of this Article and the list of drugs and drug materials banned from import or from manufacturing;

b/ Import of medicinal materials, adjuvants, capsules and primary packages of drugs;

c/ Forms of declaration for the import of drugs specified in Clause 5a and dossiers, procedures and time limit for permission for the repurposing of materials specified in Clause 5b of this Article;

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

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

“3. The Government shall provide in detail the recall of drug materials and regulations on 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/ Report on drug recall and its results to the Ministry of Health, and concurrently send it to the provincial-level Department of Health in case the latter issues the recall decision;

e/ Report on voluntary drug recall to the Ministry of Health.”;

b/ To amend and supplement Clause 2 as follows:

“2. Drug and drug material wholesalers, drug retailers, and drugstore chain-organizing establishments shall:

a/ Stop trading in, supplying or dispensing recalled drugs;

b/ Notify and organize the drug recall and receipt of recalled drugs;

c/ Return recalled drugs to drug suppliers;

d/ Pay expenses for the drug recall and disposal of recalled drugs, 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 a drug and disposal of the recalled drug nationwide, based on the severity of the violation regarding the quality, safety and efficacy of the drug; update information on drugs involved in violations and the disposal of such drugs on the Ministry of Health’s portal and the pharmaceutical information system on the national health database;

b/ Re-determine the severity of the violation and request the pharmaceutical business establishment to adjust the scope and duration of recall to suit the severity of the violation re-determined under Clauses 2 and 3, Article 63 of this Law within 24 hours after receiving the report on the voluntary drug recall of the pharmaceutical business establishment;”;

d/ To add Clause 4a below Clause 4 as follows:

“4a. Provincial-level Departments of Health shall:

a/ Decide on the drug recall under Clause 2, Article 65 of this Law based on the severity of the violation in terms of quality, safety and efficacy, and concurrently report on the drug recall to the Ministry of Health; update information on drugs involved in the violation and the disposal of such drugs on provincial-level portals and the pharmaceutical information system on the national health database;

b/ Issue notices of suspension of circulation and recall of drugs in their localities according to the Ministry of Health’s drug recall decisions;

c/ Inspect and supervise the organization of drug recalls in their localities and handle violating establishments in accordance with law.”.

35. To amend and supplement Article 65 as follows:

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

1. The Ministry of Health shall issue decisions on compulsory recall nationwide for the following drugs:

a/ Drugs involved in ­level-1 violations;

b/ Drugs involved in ­level-2 or level-3 violation due to faults of manufacturers or importers;

c/ Drugs that are to be recalled in areas, each of which covers 2 or more provinces or centrally run cities.

2. Provincial-level Departments of Health shall issue recall decisions for drugs subject to compulsory recall that are involved in level-2 or level-3 violations detected in their localities and report thereon to the Ministry of Health.

3. A recall decision for a drug shall be issued within 24 hours after the conclusion that the drug must be recalled and its violation severity is made.

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

5. The head of a drug-registering establishment, a domestic drug-manufacturing establishment, or an establishment importing or entrusted to import a drug shall issue a decision on voluntary recall of the drug and report thereon to the Ministry of Health within 24 hours after the recall decision is issued.

6. The Minister of Health shall provide in detail the making of a conclusion that a drug must be recalled, severity of the violation involving the drug, recall procedures, and disposal of the recalled drug.”.

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

“2. The Minister of Health shall provide in detail drug prescriptions and making thereof, application of information technology in making drug prescriptions, sale of prescription drugs, and linking data with the pharmaceutical information system on 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 medical examination and treatment practitioners, pharmaceutical practitioners and drug users.”;

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

“a/ Information for medical examination and treatment practitioners, pharmaceutical practitioners, including drug name, ingredients, concentration, content, preparation form, indications, contraindications, dosage, route of administration, use on special users, information related to caution and drug safety, and other necessary information;”;

c/ To add Point d below Point c, Clause 5 as follows:

“d/ Drug information may contain neither information nor images that are 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 in conformity with the documents specified in Clause 3 of this Article for medical examination and treatment practitioners, drug users, and pharmaceutical practitioners.

Employees of pharmaceutical business establishments shall introduce drugs to medical examination and treatment practitioners, drug users, and pharmaceutical practitioners under regulations of the Minister of Health;”;

dd/ To add Point dd below Point d of Clause 6 as follows:

“dd/ Organizations and individuals specified at Points a, b, and c of this Clause may only provide information on drugs permitted for circulation in Vietnam.”.

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

“2. The Minister of Health shall organize drug information and pharmacovigilance systems; and specify forms and methods of drug information.”.

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

“3. The Government shall provide in detail drug advertising contents, and dossiers and procedures for receipt, appraisal and certification of drug advertising contents; specify responsibilities of organizations and individuals that carry out or participate 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 carried out before a drug is registered for circulation, except provisions of Clause 1a of this Article.”;

b/ To add Clause 1a below Clause 1 as follows:

“1a. In order to meet requirements of the prevention and control of group-A infectious diseases that have been declared as epidemics in accordance with the law on prevention and control of infectious diseases, the Minister of Health shall grant certificates of registration for circulation for drugs that are undergoing clinical trials but their safety and efficacy must be further monitored, and subjects, quantity and scope of use must be controlled after certificates are granted provided that the drugs satisfy the following requirements:

a/ Having mid-term assessment results in stage 3 on the safety and efficacy of the drugs or the protective effect of vaccines based on data on immunogenicity of the vaccines approved by the National Biomedical Research Ethics Council;

b/ Having obtained approval of the Advisory Council for the grant of certificates of registration for circulation of drugs and drug materials.”.

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

“c/ Drugs from medicinal materials for which certificates of registration for circulation were granted before January 1, 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 covers taking samples, considering their technical standards and conducting relevant and necessary tests in order to determine their conformity with quality standards.

2. Drugs, drug materials and primary packages of drugs must be tested under regulations:

a/ Before being used for drug manufacturing, drug materials and primary packages of drugs shall be tested by drug manufacturers to ensure that they conform to quality standards.

b/ Before being delivered, drugs, drug materials and primary packages of drugs shall be tested by manufacturers to ensure that they conform to quality standards.

c/ Drug and drug material manufacturers may apply quality management measures in compliance with Good Manufacturing Practices for drugs and drug materials to replace one or more than one test for determining the quality of drugs and 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 into circulation, be tested by a drug testing establishment designated by a competent state agency:

a/ Vaccines;

b/ Biologicals being antisera;

c/ Other drugs specified by the Ministry of Health, based on results of the assessment of drug quality risks and quality of manufactured and imported drugs.

4. One or more than one or all tests of vaccines and biologicals being antisera subject to testing under Clause 3 of this Article during the testing process at a designated drug testing establishment may be exempted if they fall into one of the following cases:

a/ Being imported from a country that has concluded a mutual recognition agreement on drug testing laboratories and drug testing results with Vietnam or has drug quality assessment results of its agency competent to grant quality certificates or certificates of origin of the exporter recognized and acknowledged by Vietnam;

b/ Being required to meet urgent requirements of national defense, security, remediation of consequences of incidents, disasters, catastrophes, epidemic prevention and control or special treatment requirements;

c/ Ensuring that results of the drug risk assessment and quality trend assessment under the Ministry of Health’s regulations prove the drugs conform to quality standards in the course of manufacturing 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 and bidding for drugs at health establishments in accordance with the Bidding Law and the national reserve law.

2. Bidding, placement of orders or assignment of tasks of supplying drugs for national target programs, national defense and security purposes, remedying consequences of incidents, disasters and catastrophes, and epidemic prevention and control in accordance with law.

3. Declaring or re-declaring projected wholesale prices of prescription drugs, except cases of exemption from declaration specified by the Government for domestically manufactured drugs and drugs imported for non-commercial purposes.

4. Proposing declared  or re-declared projected drug wholesale prices during the drug circulation in the market when the Ministry of Health discovers one of the following:

a/ A drug’s projected wholesale price is higher than the declared or re-declared highest price of a similar drug without the Ministry of Health’s proposal, except the cases where the establishment has an explanatory report and documents proving the conformity with the price fluctuation. In case the drug with a projected wholesale price has a content or concentration per dosage unit different from that of similar drugs, the prices shall be compared by the method of equivalent conversion;

b/ The difference between the projected wholesale price of a drug and the winning bid of such drug is higher than the maximum difference specified by the Government, except the case the establishment has an explanatory report and documents proving the conformity with the price fluctuation;

c/ Drugs with declared or re-declared projected wholesale prices that do not yet have similar drugs circulated in Vietnam and having declared or re-declared prices higher than selling prices in the countries of origin or other countries, except the case where the establishment has an explanatory report and documents proving the conformity with the price fluctuation;

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

6. Posting up wholesale and retail drug prices in accordance with the price law.

7. Stabilizing drug prices in accordance with the price law.

8. Making joint consultations on drug prices in accordance with the price law.

9. Negotiating drug prices for bidding packages for purchase of drugs that apply the price negotiation method specified by the bidding law.

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

11. The Government shall provide in detail the declaration and re-declaration of projected wholesale prices of 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, and have the following tasks:

1. To formulate and submit to competent state agencies for promulgation, or promulgate 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 irregularly report on the state management of drug prices;

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

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

5. To receive and review drug information in dossiers for declaration or re-declaration of projected drug wholesale prices and post such prices on the Ministry of Health’s portal within 7 working days after receiving complete dossiers;

6. To publicize the Ministry of Health’s recommendations on declared or re-declared projected wholesale drug prices prescribed in Clause 4, Article 107 of this Law;

7. To examine, inspect 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 state management of drug prices in accordance with the price law.”.

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

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

47. To amend and supplement Article 113 as follows:

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

To publicize winning bids of drugs covered by health insurance funds on its portal.”.

48. To replace and annul words and phrases in the following points and clauses:

a/ To replace the phrase “drugs on the list of drugs under special control and the list of drugs subject to limited retail” at Point b, Clause 1 of Article 48 and Point b, Clause 1 of Article 49 with the phrase “drugs under special control and drugs on the list of drugs subject to limited retail”;

b/ To replace the phrase “(Points) m and n, 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. with the phrase ““ (Points) m, n and q, Clause 2, Article 42 of this Law”;

c/ To remove the phrase “certified copies” from Clause 2, 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/ To remove the word “copy” from Clause 2, Article 25, and Clauses 2 and 3 of Article 26.

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

Article 2. To amend and supplement Law No. 16/2023/QH15 on Price

To amend and supplement Item 9 in Appendix No. 01 - the List of goods and services subject to price valorization - to 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 1, 2025, except the case specified in Clause 2 of this Article.

2. The following provisions take effect on January 1, 2025:

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

b/ Provisions on the extension of certificates of registration for circulation of drugs and drug materials in Clause 30, Article 1 of this Law.

3. Transitional provisions:

a/ Dossiers of request for grant, modification and supplementation of certificates of registration for circulation of drugs and drug materials and dossiers of request for certification or modification of drug information that are submitted before July 1, 2025, but remain unsettled must comply with Law No. 105/2016/QH13 on Pharmacy, which had a number of articles amended and supplemented under Law No. 28/2018/QH14, except the case the establishment requests the compliance with this Law;

b/ Drug prices that are declared or re-declared under Clause 3, Article 107 of Law No. 105/2016/QH13 on Pharmacy, which had a number of articles amended and supplemented under Law No. 28/2018/QH14, may continue to be applied and be considered the projected drug wholesale prices that are declared or re-declared under this Law.-

This Law was passed on November 21, 2024, by the 15^th National Assembly of the Socialist Republic of Vietnam, at its 8^th session.-

Chairperson of the National Assembly
TRAN THANH MAN