The National Assembly passed the revised Law on Pharmacy with 7 basic new points.

On the afternoon of November 21, National Assembly deputies voted by electronic button to pass the Law amending and supplementing a number of articles of the Law on Pharmacy.

The law will come into effect from January 1, 2025.

Click to approve the entire draft of the Pharmacy Law

Before the National Assembly deputies voted to approve the entire draft Law amending and supplementing a number of articles of the Law on Pharmacy, the National Assembly voted to approve two contents.

Firstly, regarding Clause 23, Article 1 on the rights and responsibilities of establishments organizing pharmacy chains and pharmacies in the pharmacy chain, the voting results showed that 427/434 National Assembly deputies participated in the vote in favor (accounting for 89.14%), the National Assembly approved this content.

Second, Clause 30, Article 1 on the authority, records, procedures, time for granting and extending the registration certificate for circulation of drugs and pharmaceutical ingredients, the voting results showed that 413/419 National Assembly deputies participating in the vote voted in favor (86.22%), the National Assembly approved this content.

After the National Assembly voted to approve the above two contents, Vice Chairwoman of the National Assembly Nguyen Thi Thanh proposed that National Assembly deputies vote to approve the entire draft Law amending and supplementing a number of articles of the Law on Pharmacy.

The voting results showed that 426/430 (88.94%) of the National Assembly delegates present approved the Law amending and supplementing a number of articles of the Pharmacy Law. Thus, with the majority of delegates participating in the vote in favor, the National Assembly officially passed the Law amending and supplementing a number of articles of the Pharmacy Law.

According to the leader of the Ministry of Health, the development of the Law amending and supplementing a number of articles of the Law on Pharmacy aims to ensure that people have access to quality, timely, and reasonably priced drugs; promptly remove difficulties and obstacles in institutional and legal aspects of drug management activities; ensure drugs for disease prevention and control and urgent cases arising in practice; continue to reform administrative procedures in pharmaceutical activities, ensure increased access to drugs for people, and create favorable conditions for people and businesses.

7 basic new points groups

Previously, before the National Assembly deputies voted to pass the draft Law on Pharmacy, the National Assembly listened to Chairwoman of the Social Committee Nguyen Thuy Anh briefly present a report on receiving, explaining and revising the draft Law amending and supplementing a number of articles of the Law on Pharmacy.

Ms. Nguyen Thuy Anh read Report No. 1062/BC-UBTVQH15 dated November 20, 2024 (Report No. 1062) on receiving, explaining and revising the draft Law amending and supplementing a number of articles of the Law on Pharmacy (draft law) and the dossier of the draft law.

In the process of receiving and revising, the National Assembly Standing Committee has directed the dissemination and implementation of the policy of innovative thinking in law-making, ensuring that regulations are clear, substantive, concise, easy to understand, easy to implement, and closely following reality; enhancing decentralization and delegation of powers associated with the tasks and powers of agencies, organizations, and individuals to improve enforcement capacity; simplifying administrative procedures; only prescribing contents within the authority of the National Assembly; assigning the Government and ministries to prescribe contents within their authority to promptly amend and supplement when necessary.

The revised draft law consists of 3 articles, of which Article 1 amends 50 articles, abolishes 2 points, 2 clauses and 1 article of the current Pharmacy Law, and adds 3 new articles; Article 2 amends and supplements Appendix No. 01 issued with Price Law No. 16/2023/QH15; Article 3 on Implementation provisions.

Compared with the current law, the draft Law amending and supplementing a number of articles of the Law on Pharmacy has 7 basic new groups of points:

1. The State's policy on pharmaceuticals continues to be perfected, institutionalizing the Party's viewpoints with the goal of developing the Vietnamese pharmaceutical industry into a spearhead industry.

Accordingly, the draft law adds a number of more innovative provisions compared to the 2016 Pharmacy Law to attract investment and further promote research and development of drug and pharmaceutical ingredient production, such as preferential policies on administrative procedures when granting circulation registration certificates and import licenses; policies on applying incentive mechanisms and support from support funds for scientific and technological activities in research, development, clinical trials, technology transfer, and production of drugs and pharmaceutical ingredients; policies on price maintenance and price reduction for some groups of drugs with production technology transfer; policies on digital transformation in pharmaceutical activities; determining the scale of projects in the pharmaceutical sector that are eligible for incentives and special investment support, and assigning the Government to provide detailed regulations to ensure feasibility and bring the State's policies on pharmaceuticals and pharmaceutical industry development into life.

2. Create a legal corridor for new business forms and methods, namely: regulations on the establishment of a pharmacy chain as a separate type of pharmaceutical business establishment, business conditions, rights and responsibilities of the establishment of a pharmacy chain, pharmacies in the pharmacy chain, notably the right to rotate drugs and the right to rotate people responsible for pharmaceutical expertise between pharmacies in the pharmacy chain; regulations on the trading of drugs and pharmaceutical ingredients by e-commerce, specifically, supplementing regulations on electronic means, types of drugs and pharmaceutical ingredients allowed to be traded by e-commerce; supplementing the rights and responsibilities of pharmaceutical business establishments by this method.

3. Specify the rights and responsibilities of foreign-invested pharmaceutical businesses in the law to ensure publicity and transparency in state management.

4. Expand the rights of manufacturing establishments, export and import establishments, and drug and pharmaceutical ingredient wholesale establishments to sell directly to a number of medical facilities, drug rehabilitation facilities, testing facilities, research and training facilities, and a number of other facilities; allow medical examination and treatment establishments to import drugs to serve the special treatment needs of patients at the medical examination and treatment establishments.

5. Promote administrative procedure reform in drug and pharmaceutical ingredient registration in the direction of classifying drugs and pharmaceutical ingredients based on different levels of drug properties as well as circulation to adjust records, procedures, time limits for granting, extending, changing, and supplementing drug and pharmaceutical ingredient registration certificates accordingly to increase the ability for people to access drugs early while still ensuring the effectiveness of state management, quality control, safety and effectiveness of drugs; supplement regulations to limit the issuance of duplicate registration numbers. At the same time, there are specific regulations on records, procedures for drug and pharmaceutical ingredient registration, drug testing and drug business in general to meet the requirements of national defense, security, natural disasters, catastrophes and epidemics.

6. Abolish the procedure for confirming drug information content. Strengthen decentralization, delegation of authority, and promote the role of the Department of Health in recalling and promptly handling drugs that violate quality in the management area, ensuring safe and effective use of drugs.

7. Prescribe price management measures to comply with the Law on Prices and specific measures in drug price management to announce and re-announce expected wholesale prices applicable to prescription drugs, ensuring that drug wholesale through intermediary levels does not exceed the announced expected wholesale prices.