Law on Medicines 2024 number 44/2024/QH15

 

LAW

AMENDMENTS AND SUPPLEMENTS TO CERTAIN ARTICLES OF THE PHARMACEUTICAL LAW

On the basis of the Constitution of the Socialist Republic of Vietnam;

The National Assembly promulgates this Law amending and supplementing certain articles of the Pharmaceutical Law No. 105/2016/QH13 which has been amended and supplemented by Law No. 28/2018/QH14.

Article 1. Amendments and supplements to certain articles of the Pharmaceutical Law

1. Amend and supplement certain clauses of Article 2 as follows:

a) Amending and supplementing Clause 5 as follows:

"5. Herbal medicines (including traditional herbal medicines) are raw materials for making medicine derived from plants, animals, minerals, fungi, and meeting the standards for medicinal use.";

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

"8. Traditional medicines are medicines with components from one or more herbal medicines combined according to the theory of traditional medicine or folk experience and processed or prepared according to traditional medical methods, in traditional or modern forms.

9. Traditional herbal medicines are herbal medicines that have been preliminarily processed or prepared according to the theory of traditional medicine or folk experience for the production and preparation of traditional medicines.

10. Biologics (also called biological drugs) are medicines produced using biotechnology or biological processes from high-molecular-weight substances of biological origin, including microorganisms and derivatives of human blood and plasma.

Biologics do not include in vitro diagnostic reagents, antibiotics, and low-molecular-weight biological substances that can be purified into pure substances.";

c) Amend and supplement Clauses 17, 18, and 19 as follows:

"17. Narcotic drugs are medicines containing psychoactive or neuro-inhibiting substances that easily cause addiction in users, listed in the Catalogue of Narcotic Substances issued by the Minister of Health, except for combination medicines containing narcotic substances as stipulated in Clause 20 of this Article.

18. Psychotropic drugs are medicines containing psychoactive or neuro-inhibiting substances or hallucinogens, if used repeatedly may lead to addiction in users, listed in the Catalogue of Psychotropic Substances issued by the Minister of Health, except for combination medicines containing psychotropic substances as stipulated in Clause 21 of this Article.

19. Precursor chemicals are medicines containing precursors listed in the Catalogue of Precursors Used in Medicines issued by the Minister of Health, except for combination medicines containing precursors as stipulated in Clause 22 of this Article.";

d) Amend and supplement Clause 27 as follows:

"27. Over-the-counter medicines are medicines that can be dispensed, sold, or used without a prescription, determined based on principles and criteria established by the Minister of Health and included in the List of Over-the-Counter Medicines published by the Ministry of Health.";

đ) Amend and supplement Clause 37 as follows:

"37. Good practices are sets of principles and standards for the production, storage, testing, wholesale, retail sale of medicines and raw materials for medicines; prescribing medicines, clinical trials; cultivation and harvesting of herbal medicines, and other sets of principles and standards established or recognized for application by the Minister of Health.";

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

"44. Expected wholesale price of medicines is the maximum wholesale price determined by the importer or manufacturer before wholesaling the first batch of medicines to the market, which retail businesses are not allowed to exceed.

45. Announcement of expected wholesale price of medicines is the act of the importer or manufacturer sending notice of the expected wholesale price of medicines to the Ministry of Health before wholesaling the first batch of medicines to the market for public disclosure on the Ministry's electronic portal.

46. Reannouncement of expected wholesale price of medicines is the act of the importer or manufacturer sending notice of the expected wholesale price of medicines to the Ministry of Health when there is a change in the previously announced expected wholesale price for public disclosure on the Ministry's electronic portal.

47. Similar pharmaceutical products are medicines with the same active ingredients, herbal medicines, the same dosage form, and the same technical criteria.

48. Pharmacy chain is a system of pharmacies under a pharmacy chain organization operating under a unified quality management system under the same brand name.

49. Raw materials for medicines not meeting quality standards are raw materials for medicines that do not meet registered or announced quality standards with competent state authorities.

50. High-tech medicines are medicines listed in the Catalogue of High-Tech Products approved by the Prime Minister or medicines produced or prepared using high-tech processes listed in the Catalogue of High Technologies approved by the Prime Minister.”. "3. Ministries and ministerial-level agencies within their respective functions and powers shall implement state management over pharmaceuticals, manage substances used as medicines but prohibited from use within their jurisdiction, and coordinate with the Ministry of Health in implementing state management over pharmaceuticals as prescribed by the Government.".

4. Supplementing Clause 6 after Clause 5 of Article 4 as follows:

"2. Engaging in pharmaceutical business at locations not recorded on the Certificate of Eligibility for Pharmaceutical Business or permitted by competent state authorities, except for transactions conducted through e-commerce."

3. Amend and supplement some points and clauses of Article 6 as follows:

a) Amend and supplement Clause 2 as follows:

b) Amend and supplement Point i Clause 5 as follows:

"i) Wholesaling prescription medicines at prices higher than the announced or reannounced expected wholesale prices; wholesaling or retailing medicines at prices higher than the listed prices."

"8. Practicing in positions specified in Article 11 of this Law without a Pharmaceutical Practice Certificate or outside the scope of practice stated in the Pharmaceutical Practice Certificate or practicing during the period when the right to use the Pharmaceutical Practice Certificate has been revoked."

c) Amend and supplement Clause 8 as follows:

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

"17. Retailing medicines through e-commerce for the following types of medicines:

a) Prescription medicines, except in cases of isolation due to infectious diseases classified as Group A and declared as epidemics according to laws on prevention and control of infectious diseases;

b) Medicines subject to special control;

c) Medicines listed in the Catalogue of Restricted Retail Medicines.

18. Wholesaling medicines subject to special control through e-commerce.

19. Trading in medicines and raw materials for medicines through e-commerce via means that are not trading platforms, e-commerce applications, or online shopping websites with online ordering functions.".

"Article 7. State policy on pharmaceuticals

4. To amend and supplement Article 7 as follows:

"Article 7. State policy on pharmaceuticals

1. Ensure adequate and timely supply of quality drugs at reasonable prices to meet the needs for disease prevention and treatment of the people, consistent with the disease structure and requirements for national defense and security, disaster relief, and epidemic prevention and control.

2. Ensure rational, safe, and effective drug use; develop policies to promote clinical pharmacy activities and pharmacovigilance.

3. Implement preferential policies and support to develop the pharmaceutical industry into a leading industry.

4. For drugs purchased from state budget funds or other legitimate revenue sources of public health facilities, procurement shall be carried out in accordance with the provisions of the law on bidding and preferential drug purchases in the following cases:

a) Drugs researched and produced domestically using domestic raw materials, original brand-name drugs transferred technology in Vietnam, the first generic drugs produced domestically, and the first similar biological products produced domestically;

b) Traditional medicine and traditional drugs produced from domestic medicinal herbs that comply with Good Agricultural and Collection Practices (GACP);

c) Traditional medicine and traditional drugs produced based on national, ministerial, or provincial scientific and technological tasks that have been accepted;

d) Products listed in the National Product List approved by  the Prime Minister.

5. Prioritize administrative procedures as follows:

a) Regarding the sequence, procedures, and time for issuing registration certificates for new drugs; original brand-name drugs; rare drugs; vaccines; the first generic drugs produced domestically; the first similar biological products produced domestically; high-tech drugs; drugs tested clinically in Vietnam; drugs produced from medicinal herbs that comply with GACP; drugs and raw materials for drugs produced based on national-level scientific and technological tasks that have been accepted; drugs serving national defense and security needs, disaster relief, and epidemic prevention and control;

b) Regarding criteria, procedures, and time for issuing import permits for new drugs; rare drugs; vaccines pre-assessed by the World Health Organization; high-tech drugs; drugs tested clinically in Vietnam; drugs serving national defense and security needs, disaster relief, and epidemic prevention and control.

6. Apply preferential mechanisms and support from the National Science and Technology Development Fund, the National High-Tech Venture Capital Fund, and other funds supporting scientific and technological activities in the following cases:

a) Research, development, clinical trials, technology transfer, production, and commercialization of raw materials for drugs, new drugs, vaccines, biologics, the first generic drugs produced domestically, modernized traditional drugs, and medicinal herbs produced based on national, ministerial, or provincial scientific and technological tasks;

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

7. Combine state budget investment with mobilizing other resources for the development of vaccine, biologic, herbal drug, and traditional drug production industries; cultivation and production of medicinal herbs; discovery, conservation, and application of science and technology in researching and developing valuable, rare, and endemic medicinal herb genetic resources.

8. Support and create conditions for the discovery, clinical trials, registration, intellectual property protection, and inheritance of traditional drugs and herbal drugs produced based on national, ministerial, or provincial scientific and technological tasks that have been accepted; exploration and utilization of new medicinal herbs; export of cultivated medicinal herbs; transplantation of medicinal herbs; sustainable harvesting of natural medicinal herbs; research, survey, and investigation of medicinal plant species suitable for local cultivation; development of medicinal herb cultivation areas; modernization of production and implementation of trade promotion policies to export herbal drugs and traditional drugs.

9. Implement policies to protect confidentiality in the preparation and processing of traditional drugs and data from their clinical trials; provide reasonable incentives for individuals who donate valuable traditional prescriptions to the State; create conditions for granting professional practice certificates to holders of family-prescribed traditional prescriptions recognized by the Ministry of Health.

10. Encourage the development of a professional, modern, and efficient drug supply system to ensure timely and adequate supply of quality drugs to meet the people's drug usage needs; encourage pharmacies and drug counters to operate 24/7.

Provide preferential policies and support for the development of drug supply systems and retail drug outlets in ethnic minority regions, mountainous areas, islands, and economically disadvantaged regions.

11. Mobilize medical facilities under the People's Armed Forces, military-civilian medical examination and treatment facilities to participate in drug supply and medicinal herb cultivation to meet the needs for disease prevention and treatment of the people in ethnic minority regions, mountainous areas, islands, and economically disadvantaged regions.

12. Implement policies to improve the quality of the pharmaceutical workforce and support the training of high-quality human resources in research, development, technology transfer, production, and clinical trials of new drugs, original brand-name drugs, high-tech drugs, herbal drugs, and traditional drugs.

13. Implement price stabilization and reduction policies for new drugs, original brand-name drugs, high-tech drugs, vaccines, and rare drugs transferred technology for production in Vietnam.

14. Implement policies to control the number of drug registration certificates for drugs with the same active ingredients or medicinal herbs in line with economic and social conditions during each period.

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

16. The Government shall specify the details of this Article.

5. Amending and supplementing Article 8 as follows:

"Article 8. Preferential and Support Policies for Investment in Pharmaceutical Industry Development

1. Implement preferential and support policies for investment projects in the pharmaceutical sector according to the provisions of the Law on Investment.

2. New investment projects established (including expansion of new projects) in developing the pharmaceutical industry with total investment capital of VND 3,000 billion or more, which have disbursed at least VND 1,000 billion within three years from the date of issuance of the Investment Registration Certificate or approval of the investment proposal, shall be entitled to special preferential and investment support measures as specified in point a, Clause 2, Article 20 of the Investment Law, including:

a) Research and development of technology, production, or transfer of technology for the production of herbal medicines, traditional medicines from domestic medicinal materials, active pharmaceutical ingredients, new drugs, original brand-name drugs, rare drugs, first generic drugs produced domestically, high-tech drugs, vaccines, biological products;

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

c) Research to conserve and develop valuable and rare genetic resources of medicinal plants; creation of new varieties from genetic resources of medicinal plants with high economic value.

3. The Government shall provide detailed regulations for this Article.

6. Amend and supplement some points and clauses of Article 10 as follows:

a) Amendments and supplements to Point a Clause 3 as follows:

"a) Lead and coordinate with the Ministry of Health and the Ministry of Science and Technology in drafting regulatory documents to serve management and implementation of activities related to selection, breeding, cultivation, and harvesting of medicinal plants; disseminate techniques for cultivation, disease prevention, and pest control in medicinal plants and medicinal animals;"

b) Amend and supplement point a, Clause 6 as follows:

"a) Submit to competent authorities or allocate funds within their authority to implement plans and programs for developing the pharmaceutical industry according to the State Budget Law;"

c) Amend and supplement Clause 7 as follows:

"7. The Ministry of Science and Technology shall have the following responsibilities:

a) Submit to competent authorities or allocate funds annually from the state budget for scientific and technological activities to promote research and application of research results in drug production according to the law, especially for drugs listed in the National Product Catalogue;

b) Lead and coordinate with the Ministry of Agriculture and Rural Development and the Ministry of Health to organize research on conservation and sustainable use of valuable and rare genetic resources of medicinal plants; research on selection, breeding, cultivation, disease prevention, and pest control in medicinal plants and medicinal animals, and harvesting of medicinal plants;

c) Lead and coordinate with the Ministry of Health to establish mechanisms and policies to protect intellectual property rights for traditional medicines;

d) Lead and coordinate with relevant ministries and agencies to establish mechanisms and policies to apply science and technology to develop the chemical pharmaceutical industry."

d) Amend and supplement point b, Clause 8 as follows:

"b) Allocate land for building pharmaceutical factories, pharmaceutical industrial zones, projects to develop medicinal plant sources, and medicinal plant cultivation areas according to the Land Law."

7. Amend and supplement point b, Clause 1 of Article 12 as follows:

"b) A person who has been issued a Drug Practitioner Certificate but whose certificate was revoked according to Article 28 of this Law. The Drug Practitioner Certificate can only be reissued after 24 months from the revocation date in cases specified in Clauses 4, 6, 10, and 11 of Article 28 of this Law."

8. Add Article 17a after Article 17 as follows:

"Article 17a. Conditions for the Person Responsible for Professional Matters in Pharmaceutical Chains and Pharmacies in Pharmaceutical Chains

1. The person responsible for professional matters in pharmaceutical chains must hold a degree as specified in point a, Clause 1 of this Article and have two years of practical experience in a pharmaceutical establishment.

2. The person responsible for professional matters in each pharmacy in the pharmaceutical chain must meet the conditions specified in Clause 1 of Article 18 of this Law."

9. Amend and supplement Clause 7 of Article 24 as follows:

"7. Criminal record certificate, except when the criminal record database is updated and shared with the receiving agency according to the Government's regulations.

10. Amend and supplement Clause 8 of Article 28 as follows:

"8. A person who has been issued a Drug Practitioner Certificate but did not engage in any professional activity recorded on the Drug Practitioner Certificate for a continuous period of 24 months."

11. Amend and supplement some clauses of Article 31 as follows:

"3. Shall be professionally responsible for only one pharmaceutical business establishment and at one business location, except as provided in Clause 3a of this Article;"

a) To amend and supplement Clause 3 as follows:

"3a. The person responsible for professional matters in pharmaceutical chains must bear overall professional responsibility for the activities of the pharmaceutical chain."

b) Add Clause 3a after Clause 3 as follows:

12. Amend and supplement some points and clauses of Article 32 as follows:

"a) Engage in the sale of drugs and raw materials for drugs, including sales through e-commerce platforms, e-commerce applications, and online shopping websites;"

a) Amend and supplement point a, Clause 1 as follows:

b) Supplement point i after point h, Clause 2 as follows:

"i) Pharmaceutical chain establishments."

13. Add point h after point g, Clause 1 of Article 33 as follows:

"h) Pharmaceutical chain establishments must comply with the conditions specified in point c of this clause, have at least two directly affiliated pharmacies that have obtained a Business Registration Certificate for Pharmaceutical Activities, and have a unified quality management system applicable to all pharmacies in the chain."

14. Amend and supplement point d, Clause 1 of Article 35 as follows:

14. Amend and supplement Point d Clause 1 of Article 35 as follows:

"d) Medical facilities under the people's armed forces, military-civilian medical examination and treatment facilities operating pharmaceutical supply services in areas inhabited by ethnic minorities, mountainous regions, islands, economically and socially disadvantaged areas, and extremely economically and socially disadvantaged areas."

15. Amend and supplement Clause 3 of Article 36 as follows:

"3. Adjust the Certificate of Eligibility for Pharmaceutical Business in the following cases:

a) Change in the name of the facility or business address;

b) Change in the scope of pharmaceutical business without changing the conditions for pharmaceutical business;

c) Change in information about the person responsible for pharmaceutical expertise recorded in the Certificate of Eligibility for Pharmaceutical Business, except in cases where there is a rotation of the person responsible for pharmaceutical expertise among pharmacies within a pharmacy chain."

16. Amend and supplement Clause 1 of Article 37 as follows:

"1. The Minister of Health shall issue, reissue, adjust, and revoke the Certificate of Eligibility for Pharmaceutical Business for pharmaceutical business establishments specified in Points a, b, c, e, g, h, and i of Clause 2 of Article 32 of this Law."

17. Supplement some points to Article 38 as follows:

a) Supplement Point d with Point đ after Point d of Clause 1 as follows:

"đ) List of pharmacies in the pharmacy chain that have been issued the Certificate of Eligibility for Pharmaceutical Business up to the time of submitting the application for establishments organizing a pharmacy chain;"

b) Supplement Point đ after Point d of Clause 2 as follows:

"đ) List of pharmacies in the pharmacy chain that have been issued the Certificate of Eligibility for Pharmaceutical Business up to the time of submitting the application for establishments organizing a pharmacy chain."

18. Amend and supplement some points and clauses of Article 42 as follows:

a) Amend and supplement Point đ and add Point e after Point đ of Clause 1 as follows:

"đ) Organize mobile retail drug outlets in areas inhabited by ethnic minorities, mountainous regions, islands, economically and socially disadvantaged areas, and extremely economically and socially disadvantaged areas in accordance with the provisions of the Government;

e) Purchase and sell prescription drugs from the date the Ministry of Health receives the application for announcing or reannouncing the wholesale price forecast of the drug production or import establishment;"

b) Add Point q after Point p of Clause 2 as follows:

"q) Be responsible before the law for the accuracy, legality, and honesty of submitted documents and materials;"

c) Supplement Clause 4 after Clause 3 as follows:

"4. In addition to the rights and responsibilities stipulated in Clauses 1, 2, and 3 of this Article, when conducting business through electronic commerce, pharmaceutical business establishments shall have the following rights and responsibilities:

a) Comply with laws on electronic transactions, laws on electronic commerce, laws on advertising, laws protecting consumer rights, and other relevant laws;

b) Ensure the confidentiality of customer information in accordance with the law;

c) Publish complete information about the Certificate of Eligibility for Pharmaceutical Business, the Professional Practice Certificate of the person responsible for pharmaceutical expertise of the establishment, and information about approved drugs according to the Government's regulations;

d) Notify the competent authority of the conduct of pharmaceutical business through electronic commerce as prescribed by the Minister of Health;

đ) Retail pharmacies must organize online counseling and guidance on drug usage for customers and arrange for drug delivery to customers in accordance with the regulations of the Minister of Health;

e) Only sell over-the-counter drugs that are not special controlled drugs and are not included in the restricted over-the-counter drug list. Sell prescription drugs according to the regulations of the Minister of Health during quarantine due to infectious diseases classified as Group A and declared as epidemics under the law on prevention and control of infectious diseases;

g) Only sell wholesale drugs and raw materials for drugs that are not special controlled drugs;

h) Comply with other regulations of the Government on wholesale drugs and raw materials for drugs, and retail drugs through electronic commerce."

19. Amend and supplement some points and clauses of Article 43 as follows:

"a) Amend and supplement Point e of Clause 1 as follows:"

"e) Wholesale drugs and raw materials for drugs produced by the establishment itself to medical examination and treatment facilities, vaccination centers, and other healthcare facilities; drug rehabilitation centers; state-owned drug testing facilities; scientific and technological organizations and training institutions involved in drug research and teaching; pharmaceutical business establishments specified in Clause 2 of Article 32 of this Law; investment registration certificate holders for drug production but not yet issued the Certificate of Eligibility for Pharmaceutical Business for trial production and evaluation of the drug production process;"

b) Add Point e after Point đ of Clause 2 as follows:

"e) Implement the announcement and reannouncement of the wholesale price forecast of drugs according to this Law;"

20. Amend and supplement some points and clauses of Article 44 as follows:

a) Amend and supplement point a, Clause 1 as follows:

"a) Rights stipulated in Points a, b, c, d, and e of Clause 1 of Article 42 of this Law;"

b) Amend and supplement Point d of Clause 1 as follows:

"d) Wholesale drugs and raw materials for drugs imported by the establishment itself to medical examination and treatment facilities, vaccination centers, and other healthcare facilities; drug rehabilitation centers; state-owned drug testing facilities; scientific and technological organizations and training institutions involved in drug research and teaching; pharmaceutical business establishments specified in Clause 2 of Article 32 of this Law; investment registration certificate holders for drug production but not yet issued the Certificate of Eligibility for Pharmaceutical Business for trial production and evaluation of the drug production process;"

c) Add Point c after Point b of Clause 2 as follows:

"c) Implement the announcement and reannouncement of the wholesale price forecast of drugs according to this Law."

21. Amend and supplement some points and clauses of Article 46 as follows:

a) Amending and supplementing Point b Clause 1 as follows:

"b) Selling wholesale drugs and drug ingredients to healthcare facilities for diagnosis and treatment, vaccination centers, other medical facilities; drug rehabilitation facilities; state-owned drug testing facilities; scientific and technological organizations, training institutions involved in pharmaceutical research and teaching; pharmaceutical business entities as stipulated in Clause 2, Article 32 of this Law; entities that have been granted investment registration certificates for drug production but have not yet obtained certificates of qualification for pharmaceutical business to conduct trial production and evaluate drug manufacturing processes;"

b) Add Point c after Point b of Clause 2 as follows:

"c) Declare wholesale drug prices in accordance with Clause 5, Article 107 of this Law."

22. Amend and supplement some Points and Clauses of Article 47 as follows:

a) Amending and supplementing Point b Clause 1 as follows:

"b) Purchase drug ingredients to compound drugs based on prescriptions and sell these drugs at pharmacies or as provided in Point b, Clause 3, Article 47a of this Law. The person responsible for pharmacy practice at the pharmacy shall be directly responsible for managing the compounding of drugs at the pharmacy;"

b) Add Point d after Point c of Clause 2 as follows:

"d) Declare retail drug prices in accordance with Clause 5, Article 107 of this Law."

23. Add Article 47a after Article 47 as follows:

"Article 47a. Rights and Responsibilities of Entities Organizing Pharmacy Chains and Pharmacies within the Chain

1. Entities organizing pharmacy chains shall have the following rights:

a) Rights as stipulated in Clause 1, Article 42 of this Law;

b) Purchase drug ingredients to transfer to pharmacies within the chain to compound drugs based on prescriptions and sell these drugs at the pharmacies where they were compounded;

c) Purchase drugs to transfer to pharmacies within the chain for retail sale, except vaccines. In cases involving special control drugs and drugs listed in the Restricted Retail Drug List, such purchases shall comply with the provisions of Article 34 of this Law;

d) Rotate drugs between the entity's drug storage facility and pharmacies, and among pharmacies within the chain, excluding compounded prescription drugs. Drug rotation shall be coordinated by the person responsible for pharmacy practice at the entity organizing the chain;

đ) Rotate the person responsible for pharmacy practice among pharmacies within the chain.

2. Entities organizing pharmacy chains shall have the following responsibilities:

a) Responsibilities as stipulated in Points a, b, c, d, đ, h, k, l, m, n, and q of Clause 2, Article 42 of this Law;

b) Establish a quality management system for the pharmacy chain including organizational structure, procedures, human resources, documentation, information systems, management systems, technical infrastructure, and systematic activities that meet Good Practices appropriate to the scope of business;

c) Manage all activities related to the supply, circulation, storage of drugs and drug ingredients, and customer-related data at all pharmacies within the chain through unified procedures;

d) Supply all drugs and drug ingredients to pharmacies within the chain;

đ) Be fully responsible for the operations of all pharmacies within the chain;

e) Report to the Ministry of Health and the Provincial Health Departments where pharmacies within the chain operate, and fulfill legal obligations when the entity organizing the chain suspends operations for six months or more or ceases operations;

g) Implement the Minister of Health’s regulations regarding notification and updating to competent authorities of lists of pharmacies within the chain; lists of pharmacists practicing at the entity organizing the chain and pharmacies within the chain; and the rotation of persons responsible for pharmacy practice among pharmacies within the chain;

h) Annually report and report upon request from authorized state drug management agencies on the operations of the entity organizing the chain and pharmacies within the chain; notify the Ministry of Health within three working days of administrative penalties imposed on pharmacies within the chain in the field of pharmacy;

3. Pharmacies within the chain shall have the following rights:

a) Rights as stipulated in Points a, d, and đ of Clause 1, Article 47 of this Law;

b) Receive drug ingredients from the entity organizing the chain to compound drugs based on prescriptions and sell these drugs at the pharmacy. The person responsible for pharmacy practice at the pharmacy shall be directly responsible for managing the compounding of drugs at the pharmacy;

c) Receive drugs from the entity organizing the chain for retail sale, except vaccines; in cases involving special control drugs and drugs listed in the Restricted Retail Drug List, such sales shall comply with the provisions of Article 34 of this Law.

4. Pharmacies within the chain shall have the following responsibilities:

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

b) Only engage in the sale of drugs supplied by the entity organizing the chain;

c) Adhere to the quality management system established by the entity organizing the chain;

d) Temporarily suspend operations if the entity organizing the chain suspends operations for six months or more;

đ) Cease operations when the entity organizing the chain ceases operations."

24. Add Point c after Point b of Clause 2, Article 48 as follows:

"c) Declare retail drug prices in accordance with Clause 5, Article 107 of this Law."

25. Add Point c after Point b of Clause 2, Article 49 as follows:

"c) Declare retail drug prices in accordance with Clause 5, Article 107 of this Law."

26. Add Point c after Point b of Clause 2, Article 50 as follows:

"c) Declare retail prices of herbal drugs and traditional medicines in accordance with Clause 5, Article 107 of this Law."

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

"Article 53a. Rights and Responsibilities of Foreign-Invested Pharmaceutical Business Entities

1. Foreign-invested pharmaceutical business entities as stipulated in Points a, b, e, g, and h of Clause 2, Article 32 of this Law shall have the following rights:

a) Rights as stipulated in Points b, c, and d of Clause 1, Article 42 of this Law;

b) The rights corresponding to the type of pharmaceutical business entity as prescribed in Points b, c, d, đ, and g Clause 1 Article 43, Points b, c, and đ 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 đ Clause 1 Article 53 of this Law.

2. A pharmaceutical production facility with foreign investment capital shall have the rights prescribed in Clause 1 of this Article and the following rights:

a) Wholesale sale, receipt, and transportation of medicines and pharmaceutical raw materials produced by the facility itself, processed on commission, or technology transferred in Vietnam to medical examination and treatment facilities, vaccination centers, other healthcare facilities; drug rehabilitation centers; state-owned medicine testing facilities; scientific and technological organizations engaged in research and teaching related to pharmacy; pharmaceutical business entities as prescribed in Clause 2 Article 32 of this Law; and facilities that have been granted an Investment Registration Certificate for medicine production but have not yet been granted a Pharmaceutical Business Qualification Certificate to conduct trial production and evaluate the production process of medicines.

In the case of selling prescription medicines, the pharmaceutical production facility may sell such medicines from the date when the Ministry of Health receives the application for publication of the wholesale price of the medicines.

b) Receipt and transportation of medicines within programs of sponsorship, aid, humanitarian assistance, and disease prevention and control to healthcare facilities receiving such support.

3. A pharmaceutical import facility with foreign investment capital shall have the rights prescribed in Clause 1 of this Article and the following rights:

a) Wholesale sale of medicines and pharmaceutical raw materials imported by the facility to wholesale pharmaceutical facilities. In the case of selling prescription medicines, the pharmaceutical import facility may sell such medicines from the date when the Ministry of Health receives the application for publication of the wholesale price of the medicines.

b) Purchase back medicines and pharmaceutical raw materials processed on commission or technology transferred in Vietnam by the facility; sell medicines and pharmaceutical raw materials processed on commission or technology transferred in Vietnam by the facility to wholesale pharmaceutical facilities;

c) Import pharmaceutical raw materials within the scope specified in the Pharmaceutical Business Qualification Certificate to supply to pharmaceutical production facilities processing on commission or technology transferred in Vietnam according to the processing contract or technology transfer contract;

d) Receipt and transportation of medicines and pharmaceutical raw materials imported, processed on commission, or technology transferred in Vietnam from the storage warehouse of the facility to wholesale pharmaceutical facilities;

đ) Delivery and transportation of medicines within programs of sponsorship, aid, humanitarian assistance, and disease prevention and control to healthcare facilities receiving such support;

e) Transportation of pharmaceutical raw materials imported by the facility from the storage warehouse of the facility to pharmaceutical production facilities processing on commission or technology transferred in Vietnam according to the processing contract or technology transfer contract; transportation of medicines used in clinical trials sponsored and imported by the facility to the clinical trial receiving facility;

4. A pharmaceutical business entity with foreign investment capital as prescribed in Points a, b, e, g, and h Clause 2 Article 32 shall have responsibilities corresponding to each type of pharmaceutical business entity as prescribed in Clause 2 Articles 42, 43, 44, 51, 52, and 53 of this Law and shall not engage in activities directly related to the distribution of medicines and pharmaceutical raw materials, including:

a) Sale, receipt, and transportation of medicines and pharmaceutical raw materials, except as provided in Clauses 2 and 3 of this Article;

b) Acceptance of storage of medicines and pharmaceutical raw materials not produced, processed on commission, or technology transferred in Vietnam by the facility itself;

c) Acceptance of orders and payment for medicines and pharmaceutical raw materials from medical examination and treatment facilities, retail outlets, individuals, or organizations that are not wholesale pharmaceutical facilities, except as provided in Clause 2 of this Article;

d) Determination and imposition of prices for medicines and pharmaceutical raw materials distributed by other pharmaceutical business entities, except when implementing regulations on medicine pricing under this Law;

đ) Decision-making on distribution strategies and business policies for medicines and pharmaceutical raw materials distributed by other pharmaceutical business entities;

e) Development of supply plans for medicines and pharmaceutical raw materials for medical examination and treatment facilities in Vietnam;

g) Financial support in any form to organizations or individuals directly purchasing medicines and pharmaceutical raw materials from the facility with the aim of manipulating the distribution of imported medicines and pharmaceutical raw materials.

5. A pharmaceutical business entity with foreign investment capital shall not engage in retail sales of medicines or wholesale sales of medicines and pharmaceutical raw materials, except as provided in Clauses 2 and 3 of this Article."

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

"b) Medicines imported as prescribed in Clause 2 and Clause 5a Article 60 of this Law;"

29. Amend and supplement Point b and Point c Clause 2 Article 55 as follows:

"b) Medicines that have been granted a circulation registration certificate but have changes or additions regarding active ingredients, herbal ingredients; dosage, concentration, quantity of active ingredients or herbal ingredients in a single dose; formulation; manufacturing facility, except for changes or additions regarding packaging facility, manufacturing facility, or place of manufacture;

c) Pharmaceutical raw materials that have been granted a circulation registration certificate but have changes or additions regarding manufacturing facility, except for changes or additions regarding packaging facility, manufacturing facility, or place of manufacture."

30. Amend and supplement Article 56 as follows:

"Article 56. Competence, Documents, Procedures, Time Limits for Issuing, Extending, Amending, and Supplementing Circulation Registration Certificates for Medicines and Pharmaceutical Raw Materials

1. The Ministry of Health shall issue, extend, amend, and supplement circulation registration certificates for medicines and pharmaceutical raw materials based on the review of applications and advice from the Advisory Council for Issuance of Circulation Registration Certificates for Medicines and Pharmaceutical Raw Materials, except as provided in Point b Clause 9 of this Article.

2. The Ministry of Health shall publicly disclose on its official website the following information:

a) Information on issuing, extending, amending, and supplementing circulation registration certificates for medicines and pharmaceutical raw materials;

b) The case provided for in point c, Clause 8 of this Article;

c) Over-the-counter drugs after being granted a drug circulation registration certificate.

3. The application dossier for a drug circulation registration certificate includes:

a) Administrative documents including the application form for a drug circulation registration certificate, raw material drug circulation registration certificate; the representative office establishment permit valid within its term of validity for foreign drug business establishments or the certificate of qualification for drug business operations for domestic drug business establishments; the pharmaceutical product certificate valid within its term of validity for imported drugs; drug labels and raw material drug labels; information on the drug and other documents related to drug business and circulation.

In cases where the need arises to meet the requirements for preventing and treating Category A infectious diseases that have been declared under the law on prevention and control of infectious diseases, the pharmaceutical product certificate may be replaced by other documents issued by the competent authority, confirming that the drug is permitted for circulation and use in the country of origin and containing full information about the name, address of the production facility, and the conditions for granting permission.

b) Technical documents proving that the drug and raw materials meet the requirements stipulated in Clause 4 of Article 54 of this Law; for new drugs, reference biological products, and vaccines, additional clinical trial documents must be submitted to prove safety and efficacy; for similar biological products, additional documents must be submitted to prove similarity in quality, safety, and efficacy compared to a reference biological product; for drugs requiring bioequivalence testing, additional reports on bioequivalence study data of the drug must be submitted; in cases where the applicant requests to apply the reference approval pathway for drug registration dossier assessment results, additional documents regarding the assessment results from stringent regulatory authorities (SRA) or recognized drug regulatory authorities by the Ministry of Health based on WHO classification must be submitted.

For domestically produced new drugs (excluding vaccines) with indications for preventing and treating Category A infectious diseases that have been declared under the law on prevention and control of infectious diseases and which have the same active ingredient, dosage form, route of administration, and indication as drugs already approved for circulation or emergency use or conditional circulation and use by stringent regulatory authorities (SRA) or recognized drug regulatory authorities by the Ministry of Health based on WHO classification, the submission of clinical trial documents in the application dossier for a drug circulation registration certificate is exempted.

c) Actual label samples of the drug and raw materials circulating in the country of origin or the reference country for imported drugs.

4. The application dossier for extending the validity period of a drug circulation registration certificate includes:

a) Application form for extending the validity period of a drug circulation registration certificate;

b) Pharmaceutical product certificate valid within its term of validity for imported drugs;

c) Safety and efficacy report of the drug during circulation.

5. The application dossier for changing or supplementing a drug circulation registration certificate includes:

a) Application form for changing or supplementing a drug circulation registration certificate;

b) Technical documents relating to the changes or supplements to the drug circulation registration certificate.

6. The time limit for issuing, extending, or changing and supplementing a drug circulation registration certificate is as follows:

a) Not exceeding twelve months from the date all required documents specified in Clause 3 of this Article are received, except in the cases provided for in points b and e of this clause;

b) Not exceeding nine months from the date all required documents specified in Clause 3 of this Article are received in cases where the application requests the reference approval pathway for drug registration dossier assessment results;

c) Not exceeding three months from the date all required documents specified in Clause 4 of this Article are received;

d) Not exceeding three months from the date all required documents specified in Clause 5 of this Article are received, except in the cases provided for in point đ of this clause;

đ) Not exceeding twenty days from the date all required documents specified in Clause 5 of this Article are received in cases where the changes or supplements to the drug circulation registration certificate do not affect the quality, safety, and efficacy of the drug;

e) Not exceeding fifteen days from the date all required documents specified in Clause 3 of this Article are received for the application dossier for the circulation of new drugs with indications for preventing and treating Category A infectious diseases that have been declared under the law on prevention and control of infectious diseases and which have been approved for circulation or emergency use or conditional circulation and use by stringent regulatory authorities (SRA) or recognized drug regulatory authorities by the Ministry of Health based on WHO classification.

7. The Ministry of Health shall issue, extend, change, or supplement a drug circulation registration certificate within the time limits specified in Clause 6 of this Article; if it does not issue, extend, change, or supplement a drug circulation registration certificate, it must provide a written response stating the reasons.

If a drug has been granted a drug circulation registration certificate but has not been circulated on the market within five years from the date the drug circulation registration certificate becomes effective, the validity period of the drug circulation registration certificate will not be extended, except for rare drugs and drugs with no more than three products from three manufacturers having the same active ingredient, herbal ingredient, dosage form, dose, or concentration of active ingredient, weight of herbal ingredient per unit dose, whose drug circulation registration certificates are still valid.

8. The validity period of a drug circulation registration certificate is as follows:

a) The validity period of a drug circulation registration certificate is five years from the date of issuance or extension, except in the cases provided for in points b and c of this clause;

b) The validity period of a drug circulation registration certificate is three years from the date of issuance or extension for drugs requiring continued monitoring of safety and efficacy.

c) The drug registration certificate and raw material for drug production shall continue to be used until the extension is granted or until the Ministry of Health issues a document notifying that the extension will not be granted or temporarily suspends the use of the drug registration certificate due to the discovery of risks to the safety of drug users or suspicion of falsification of legal documents.

9. The Minister of Health shall specify in detail the application dossier for issuing, extending, changing, and supplementing the drug registration certificate as stipulated in Clauses 3, 4, and 5 of this Article and shall prescribe the following contents:

a) Procedures for issuing, extending, changing, and supplementing the drug registration certificate;

b) Cases where the application dossier for extending, changing, or supplementing the drug registration certificate does not require review of the dossier or consultation from the Advisory Council on Drug Registration based on risk assessment related to the quality, safety, and efficacy of drugs and raw materials for drug production;

c) Issuing the drug registration certificate for new drugs with indications for the prevention and treatment of infectious diseases belonging to Group A, which have been declared as epidemics according to the laws on prevention and control of infectious diseases, based on recognition of the approval results issued by one of the strict drug regulatory authorities (SRA) or recognized drug regulatory agencies by the Ministry of Health based on the classification of the World Health Organization without requiring technical dossier review or evaluation of compliance with Good Manufacturing Practices.

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

"b) Imported drugs and raw materials for drug production as stipulated in Clauses 1, 2, 3, 4, and 5a of Article 60 of this Law;"

32. Amend and supplement some Points and Clauses of Article 60 as follows:

a) Amend and supplement Points h and i Clause 2 as follows:

"h) Bioequivalence testing, bioavailability assessment, sample registration, testing samples, scientific research, participation in exhibitions and trade fairs;

i) Other cases not for commercial purposes, including imported drugs by healthcare facilities for special treatment needs of patients;"

b) Amend and supplement Clause 3 as follows:

"3. Raw materials for drug production without a drug registration certificate in Vietnam may be permitted to import and can only be imported up to the quantity specified in the import permit under the following circumstances:

a) For sample registration, testing samples, drug research, participation in exhibitions and trade fairs;

b) For the production of exported drugs, semi-finished exported drugs, drugs serving defense and security needs, drugs to meet the requirements for the prevention and treatment of infectious diseases belonging to Group A, which have been declared as epidemics according to the laws on prevention and control of infectious diseases, to address consequences of accidents, natural disasters, and disasters; production and compounding to serve special treatment needs at healthcare facilities;"

c) Supplement Clause 5a and Clause 5b after Clause 5 as follows:

"5a. Drugs without a drug registration certificate in Vietnam used for clinical drug trials may be imported without an import permit in accordance with the information published on the Ministry of Health's website based on the approved clinical trial protocol, except for drugs stipulated in Clause 4 of this Article.

5b. The Minister of Health shall consider and decide on the use of active pharmaceutical ingredients and medicinal herbs to produce drugs with indications for the prevention and treatment of infectious diseases belonging to Group A, which have been declared as epidemics according to the laws on prevention and control of infectious diseases, using active pharmaceutical ingredients and medicinal herbs already permitted for import for other purposes;"

d) Supplement Clause 6a after Clause 6 as follows:

"6a. The Ministry of Finance shall regularly share information with the Ministry of Health on the data of specially controlled drugs that have been cleared for export and import according to the Government's regulations;"

đ) Amend and supplement Clause 7 as follows:

"7. The Government shall specify the following contents:

a) Criteria, application dossier, procedures, time limit for issuing and revoking the export and import permits for drugs and raw materials for drug production as stipulated in Clauses 2, 3, 4, and 5 of this Article and the list of drugs and raw materials for drug production prohibited from importation and production;

b) Importation of medicinal herbs, excipients, capsules, and direct contact packaging materials with drugs;

c) Declaration forms for drug imports as stipulated in Clause 5a and the application dossier, procedures, and time limit for processing changes in the purpose of use of raw materials as stipulated in Clause 5b of this Article;

d) Transfer of drugs as stipulated in Point c Clause 2 of this Article; provision of drugs imported by healthcare facilities for special treatment needs as stipulated in Point i Clause 2 of this Article to other healthcare facilities;"

33. Supplement Clause 3 after Clause 2 of Article 62 as follows:

"3. The Government shall specify detailed regulations on the recall of raw materials for drug production and regulations on the handling of recalled raw materials;"

34. Amend and supplement some Points and Clauses of Article 64 as follows:

a) Amend and supplement Points đ and e Clause 1 as follows:

"đ) Report on the recall of drugs and the results of the recall to the Ministry of Health, and simultaneously send to the Department of Health if the Department of Health issues a decision to recall;

e) Report to the Ministry of Health on voluntary recalls;"

b) Amend and supplement Clause 2 as follows:

"2. Wholesale drug enterprises, raw material for drug production enterprises, retail drug enterprises, and pharmacy chain organizations shall have the following responsibilities:

a) Cease trading, supplying, and distributing recalled drugs;

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

c) Return recalled drugs to the supplier;

d) Bear the costs of recalling and disposing of recalled drugs and compensate for losses in accordance with the law in case of fault;"

c) Amend and supplement Points a and b Clause 4 as follows:

"a) Decide on the recall and disposal of drugs recalled nationwide based on the level of violation regarding quality, safety, and efficacy; update information about violative drugs and their disposal on the Ministry of Health's website and the drug information system in the national health database;"

b) Reassess the level of violation and require the pharmaceutical business establishment to adjust the scope and time of the recall to be consistent with the reassessed level of violation as stipulated in Clause 2 and Clause 3 of Article 63 of this Law within twenty-four hours from the time of receiving the report on the voluntary recall of medicines from the pharmaceutical business establishment;

d) Supplement Clause 4a following Clause 4 as follows:

"4a. The Department of Health shall have the following responsibilities:

a) Decide on the recall of medicines according to Clause 2 of Article 65 of this Law based on the degree of violation regarding quality, safety, and efficacy, while reporting to the Ministry of Health on the recall of medicines; update information about the violative medicine, handling of violative medicines on the provincial or centrally-administered city's electronic portal and the drug information system in the national health database;

b) Issue a notice to suspend circulation and recall medicines within its jurisdiction according to the decision on the recall of medicines made by the Ministry of Health;

c) Inspect and supervise the organization and implementation of the recall of medicines within its jurisdiction and handle the violating entity according to the law.";

35. Amend and supplement Article 65 as follows:

"Article 65. Authority to decide on the recall of medicines and procedures for recalling medicines

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

a) Medicines that violate Level 1;

b) Medicines that violate Level 2 or Level 3 due to the fault of the manufacturing facility or the importing facility;

c) Medicines that have been recalled in two or more provinces or centrally-administered cities.

2. The Department of Health shall decide on the recall of medicines in cases where compulsory recalls are required for medicines that violate Level 2 or Level 3 discovered within its jurisdiction, and simultaneously report to the Ministry of Health;

3. The time limit for issuing a decision on the recall of medicines shall not exceed twenty-four hours from the time of concluding that the medicines fall under the circumstances requiring recall and the level of violation of the medicines;

4. In case additional information is needed to determine the level of violation of the medicines, within twenty-four hours from the time of receiving the report from the Department of Health or the state drug testing facility, the Ministry of Health shall issue a document requesting the supplementation of information;

5. The head of the medicine registration facility, domestic medicine manufacturing facility, importing facility, or entrusted importing facility shall decide on the voluntary recall of medicines and report to the Ministry of Health within twenty-four hours from the time of issuing the recall decision;

6. The Minister of Health shall specify detailed regulations on concluding that medicines fall under the circumstances requiring recall, the level of violation of the medicines, procedures for recalling medicines, and the handling of recalled medicines.";

36. Amend and supplement Clause 2 of Article 74 as follows:

"2. The Minister of Health shall specify detailed regulations on prescriptions, prescription writing, application of information technology in prescription writing, selling medicines according to prescriptions, and linking data with the drug information system in the national health database.";

37. Amend and supplement some points and clauses of Article 76 as follows:

a) Amend and supplement Clause 1 as follows:

"1. Information on medicines aimed at guiding the rational, safe, and effective use of medicines for medical practitioners, pharmacists, and medicine users.";

b) Amend and supplement point a of Clause 5 as follows:

"a) Information provided to medical practitioners and pharmacists includes the name of the medicine, ingredients, concentration, dosage, formulation, indications, contraindications, dosage regimen, method of administration, use of medicines in special populations, relevant warning and safety information, and other necessary information;";

c) Supplement point d following point c of Clause 5 as follows:

"d) The content of the information on medicines shall not include unrelated information or images.";

d) Amend and supplement point b of Clause 6 as follows:

"b) Pharmaceutical business establishments, foreign traders' representative offices operating in the pharmaceutical sector in Vietnam, and medicine registration facilities shall be responsible for providing appropriate medicine information as specified in Clause 3 of this Article to medical practitioners, users, and pharmacists.

Personnel from pharmaceutical business establishments shall introduce medicines to medical practitioners and pharmacists according to the regulations of the Minister of Health;";

đ) Supplement point đ following point d of Clause 6 as follows:

"đ) Organizations and individuals specified in points a, b, and c of this clause may only provide information on medicines that have been permitted for circulation in Vietnam.";

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

"2. The Minister of Health shall be responsible for organizing the drug information system and pharmacovigilance; specifying the form and manner of drug information.";

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

"3. The Government shall specify detailed regulations on the content of medicine advertisements, dossier, procedures for acceptance, review, and confirmation of advertisement content; specify the responsibility of organizations and individuals involved in advertising medicines.";

40. Amend and supplement some clauses of Article 87 as follows:

a) Amend and supplement Clause 1 as follows:

"1. Clinical trials phases 1, 2, and 3 shall be conducted before registering medicines for circulation, except as provided in Clause 1a of this Article.";

b) Supplement Clause 1a following Clause 1 as follows:

"1a. In cases where it is necessary to meet the needs for preventing and treating infectious diseases classified as Group A under the law on prevention and control of infectious diseases, the Minister of Health may decide to grant a permit for circulation of medicines that are undergoing clinical trials but must continue to monitor their safety, efficacy, control the subjects, quantity, and scope of use after granting the permit for circulation of medicines if the following requirements are met:

a) There is an interim evaluation result of phase 3 regarding the safety and efficacy of treatment of the medicine or the protective efficacy of the vaccine based on immunogenicity data of the vaccine approved by the National Bioethics Council for Research in Biomedicine;

b) There is an approval opinion from the Advisory Committee for Granting Permits for Circulation of Medicines and Raw Materials for Medicines.";

41. Amend and supplement point c of Clause 3 of Article 89 as follows:

"c) Traditional herbal medicines that were granted permits for circulation before January 1, 2017.";

"Article 103. Testing of medicines, raw materials for medicines, and direct contact packaging".

1. Drug testing, drug ingredients, and direct contact packaging involves sampling, examining technical standards, conducting corresponding and necessary tests to determine whether drugs, drug ingredients, and direct contact packaging meet quality standards.

2. Drugs, drug ingredients, and direct contact packaging must be tested according to the following provisions:

a) Drug ingredients and direct contact packaging before being used in drug production must be tested by the drug manufacturing facility and must meet quality standards;

b) Drugs, drug ingredients, and direct contact packaging before leaving the factory must be tested by the drug manufacturing facility, drug ingredient facilities, and direct contact packaging facilities and must meet quality standards;

c) Drug manufacturing facilities and drug ingredient facilities may apply quality management measures that comply with Good Manufacturing Practices for Drugs and Drug Ingredients to replace one or several tests required for determining the quality of drugs and drug ingredients as specified in points a and b of this clause.

3. In addition to being tested according to the provisions of Clause 2 of this Article, the following drugs must also be tested by designated drug testing facilities before circulation:

a) Vaccines;

b) Blood sera containing antibodies;

c) Other drugs prescribed by the Minister of Health based on risk assessment results regarding drug quality and changes in drug quality during production and importation.

4. One or more or all tests in the drug testing process at designated drug testing facilities may be exempted for vaccines and blood sera containing antibodies that must be tested according to the provisions of Clause 3 of this Article if they fall under any of the following circumstances:

a) Imported from countries with which Vietnam has mutual recognition agreements on drug testing institutions and test results, or Vietnam recognizes and accredits the quality evaluation results of competent authorities issuing quality certificates or factory release certificates of exporting countries;

b) Required to meet urgent needs for national defense, security, disaster relief, natural disasters, catastrophes, disease prevention and control, and special treatment requirements;

c) Quality risk assessment and trend analysis results according to the Ministry of Health's regulations prove that the drug meets quality standards during production and circulation.

5. The Minister of Health shall provide detailed regulations for this Article."

43. Amend and supplement Article 107 as follows:

"Article 107. Measures for Managing Drug Prices

1. National drug reserve bidding and drug bidding at healthcare facilities shall be carried out in accordance with laws on bidding and laws on national reserves.

2. Bidding, ordering, or assigning tasks to supply drugs for national target programs, national defense, security, disaster relief, natural disasters, catastrophes, disease prevention and control shall be conducted in accordance with relevant laws.

3. Announce or reannounce wholesale prices for prescription drugs, except when exempted from announcement by the Government for domestically produced drugs or imported drugs not for commercial purposes.

4. Propose adjustments to announced or reannounced wholesale prices during drug circulation on the market when the Ministry of Health discovers any of the following situations:

a) The proposed wholesale price is higher than the highest announced or reannounced price of similar drugs without a proposal from the Ministry of Health, except where the entity provides a justification report and supporting documentation demonstrating appropriate price fluctuations. If the proposed wholesale price of a drug has a different dosage or concentration compared to similar drugs, equivalent price comparisons will be made;

b) The difference between the proposed wholesale price and the winning bid price of the same drug exceeds the maximum allowable difference set by the Government, except where the entity provides a justification report and supporting documentation demonstrating appropriate price fluctuations;

c) The proposed wholesale price of a drug not yet available in Vietnam is higher than the price in the country of origin or another country, except where the entity provides a justification report and supporting documentation demonstrating appropriate price fluctuations.

5. Declare wholesale and retail prices for essential medicines as stipulated by pricing laws.

6. Display wholesale and retail prices for drugs as stipulated by pricing laws.

7. Stabilize drug prices as stipulated by pricing laws.

8. Negotiate drug prices as stipulated by pricing laws.

9. Negotiate drug prices for tender packages using negotiation methods as stipulated by bidding laws.

10. Set maximum retail markups for drugs sold at retail outlets within medical facilities.

11. The Government shall provide detailed regulations for announcing or reannouncing wholesale prices for prescription drugs and Clause 4, Clause 10 of this Article."

44. Amend and supplement Article 109 as follows:

"Article 109. Responsibilities of the Ministry of Health in State Management of Drug Prices

The Ministry of Health shall take the lead in coordinating with ministries, ministerial-level agencies, government agencies, and provincial people's committees to manage state affairs related to drug prices and perform the following tasks:

1. Lead in drafting and submitting to competent state authorities or promulgating normative legal documents within its authority and organizing the implementation of policies and laws on drug prices;

2. Request ministries, ministerial-level agencies, government agencies, and provincial people's committees to report periodically or urgently on drug price management work;

3. Lead in organizing the dissemination and education on laws related to drug prices;

4. Implement measures to stabilize drug prices as stipulated by pricing laws;

5. Organize the receipt, review information on drugs in the application dossier for announced or reannounced wholesale prices, and publicly announce the proposed wholesale prices on the Ministry of Health's website within seven working days from the date of receiving complete dossiers."

6. Publish the pharmaceutical industry's price recommendations for wholesale drug prices that have been announced or reannounced in accordance with Clause 4, Article 107 of this Law;

7. Inspect, audit, and handle violations of laws related to drug pricing."

45. Amend and supplement Article 110 as follows:

"Article 110. Responsibilities of the Ministry of Finance in managing drug prices Implement state management functions over drug prices in accordance with the law on pricing."

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

"3. Organize the receipt of price declaration files for drugs submitted by pharmaceutical business establishments within their jurisdiction, re-declare prices, and update declared drug price information and data into the national price database in accordance with the law on pricing."

47. Amend and supplement Article 113 as follows:

"Article 113. Responsibilities of the Vietnam Social Security in managing drug prices Publish winning bid drug prices paid from the health insurance fund on the Vietnam Social Security's electronic portal."

48. Replace and delete certain phrases at the following points and clauses:

a) Replace the phrase "drugs listed in the Special Control Drug List and the Retail Sale Restricted Drug List" with the phrase "special control drugs and drugs listed in the Retail Sale Restricted Drug List" at point b, Clause 1, Article 48 and point b, Clause 1, Article 49;

b) Replace the phrase "m and n Clause 2, Article 42 of this Law" with the phrase "m, n and q Clause 2, Article 42 of this Law" at point a, Clause 2, Article 43, point a, Clause 2, Article 44, Clause 2, Article 45, point a, Clause 2, Article 46, point a, Clause 2, Article 51, point a, Clause 2, Article 52, and point a, Clause 2, Article 53;

c) Delete the phrase "Certified copy" at Clause 2, Article 24, point c and point d, Clause 1, point c and point d, Clause 2, point b and point c, Clause 4, Article 38;

d) Delete the word "Copy" at Clause 2, Article 25, Clause 2 and Clause 3, Article 26.

49. Repeal Clause 6, Article 24, Clause 3, Article 78, point b, Clause 1 and point b, Clause 2, Article 89, and Article 114.

Article 2. Amend and supplement the Law on Pricing No. 16/2023/QH15

Amend and supplement Item 9 of Appendix No. 01 - List of Goods and Services for Price Stabilization issued together with the Law on Pricing No. 16/2023/QH15 as follows:
"9. Essential drugs."

Article 3. Implementation Provisions

1. This Law takes effect from July 1, 2025, except as provided in Clause 2 of this Article.

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

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

b) Provisions regarding the extension of drug registration certificates and raw material registration certificates at Clause 30, Article 1 of this Law.

3. Transitional Provisions:

a) Applications for issuance, change, and supplementation of drug registration certificates and raw material registration certificates, and applications for confirmation and adjustment of drug information submitted before July 1, 2025 but not yet resolved shall be handled according to the Drug Law No. 105/2016/QH13 amended and supplemented by Law No. 28/2018/QH14, except where the applicant requests handling under this Law;

b) Prices of drugs declared or redeclared in accordance with Clause 3, Article 107 of the Drug Law No. 105/2016/QH13 amended and supplemented by Law No. 28/2018/QH14 shall continue to be used and considered as the announced or reannounced wholesale drug prices under this Law.

This Law was passed by the National Assembly of the Socialist Republic of Vietnam, Session 8, 15th term, on November 21, 2024.