PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Draft Law amending and supplementing a number of articles of the Law on Pharmacy; (23 page(s), in Vietnamese)

This draft Law amends and supplements a number of articles of Law No. 105/2016/QH13 on Pharmacy.

These Articles include 2, 4, 6, 7, 8, 10, 17, 24, 28, 32, 33, 34, 35, 37, 42, 43, 44, 46, 47, 48, 49, 53, 54, 55, 56, 58, 59, 60, 61, 64, 65, 76, 78, 79, 87, 89, 107, 109, 110, 112, 113;

This draft Law abolishes point c and d, clause 26, Article 2, point a, clause 10, Article 6, point b, clause 4, Article 7 of Law No. 105/2016/QH13 on Pharmacy.

Transitional provisions:

1. Certificates of drug information and advertising content issued under the provisions of Law No. 105/2016/QH13 on Pharmacy will continue to be used until the expiry of the Certificate's validity

2. Dossier submitted before the entry into force of this draft Law and requesting the issuance, extension, amendment or supplementation of the registration certificate for the circulation of drugs and medicinal ingredients shall be implemented in accordance with the provisions of Law No. 105/2016 /QH13 on Pharmacy, except in cases where the establishment requests to comply with the provisions of this draft Law.

3. For dossiers applying for a License to import toxic drugs and toxic medicinal ingredients; drugs and medicinal ingredients that are on the list of substances whose use is prohibited in a number of industries and fields used for testing, research, and manufacturing of drugs for export in accordance with the provisions of the 2016 Law on Pharmacy and its guiding Decrees.

4. Chain pharmacy businesses that have had a chain pharmacy system prior to the effective date of this Law shall complete procedures to apply for a certificate of authority to do business as a chain within 45 days of the effective date of this draft Law.

The regulations on granting, extending, amendment and supplementing circulation registration certificates for drugs and medicinal ingredients, except for regulations on issuing medical oxygen product declaration forms, shall be applied from January 1, 2025

The Draft Law was formulated based on the basis of 05 policies submitted to the Government and the National Assembly of Vietnam in the proposal No. 09/TTr-BYT dated on January 5th, 2023 as well as other difficulties and issues encountered during the implementation process, as follows:

1. Policy 1: Further strengthen the sufficient and timely supply of quality-assured medicines to meet people's need for disease prevention and treatment.

2. Policy 2: Ensure sufficient and timely supply of drugs that meet the demands of security, national defense, coping with the consequences of natural disasters, and preventing epidemics and diseases in the new situation

3. Policy 3: Improve the efficiency of import/export management of drugs/medicinal materials to the socio-economic development situation and international practice

4. Policy 4: Promote the development of the pharmaceutical industry with emphasis on research, technology transfer and production of high-tech drugs, biological drugs/medicinal materials, standardized herbal medicines, and raw materials from domestically available pharmaceutical sources.

5. Policy 5: Organize and rearranging the business and distribution system for drugs/medicinal materials to cope with socio-economic development and international integration.