Vietnam's Amended Pharmacy Law: Important amendments & opportunities for businesses

Vietnam's Amended Pharmacy Law: Important amendments & opportunities for businesses

Vietnam will officially implement the Amended Pharmacy Law from July 1, 2025, after it was passed by the National Assembly on November 21, 2024. The new law is enacted to update the legal framework for the pharmaceutical industry, facilitate investment activities, enhance transparency levels, and promote domestic production as well as foreign enterprise participation.

Background and reasons for amendments

• The 2016 Pharmacy Law established the foundation for managing drug registration, production, importation, distribution, drug pricing, and pharmaceutical management.
• However, with the rapid development of the pharmaceutical market, increasing e-commerce in the pharmaceutical sector, expanded distribution chains, requirements for more accurate management of clinical trials, transportation, and manufacturing technology — the old law gradually revealed limitations.
• The lack of clear regulations or strong enforcement between GMP levels, ISO, supervisory responsibilities, and price transparency also created risks for consumers and businesses.

Notable changes in the 2024 Amended Pharmacy Law

Expansion of e-commerce & online sales

• The new law allows pharmaceutical business through e-commerce platforms, mobile applications, official websites, with clear regulations on quality assurance, electronic transactions, and user information.
• This helps people in remote and mountainous areas access medicines more easily, while requiring strict compliance with infection control and ensuring accuracy of drug information.

Benefits for foreign-invested enterprises

• Foreign Investment Enterprises (FIEs) are granted expanded rights to import raw materials, distribute, transfer technology, and participate in contract manufacturing of drugs produced in Vietnam.
• The new law also facilitates enterprises to transport medicines between warehouses, manufacturing facilities, or between distributors and healthcare facilities, providing better support for healthcare programs or special services.

Streamlining drug registration procedures and marketing authorization renewal

• Shortened evaluation time for reference drug registration from 12 months to 9 months.
• Drugs that have been granted marketing authorization (MA) but have not been marketed for 5 years, if not wanting to apply additional renewal procedures, may be exempted from some requirements.
• Expired MA can still remain valid if renewal applications are being processed, to avoid disruption in drug supply.

Clinical trials & drug importation

• Drugs without marketing authorization can be imported for use in clinical trials, with clear regulations on types and quantities.
• Clinical trial regulations are clarified to ensure research processes and technology transfer occur transparently and safely.

Drug price management and transparency

• Manufacturers and importers must declare wholesale prices of drugs to the Ministry of Health before drugs are launched to market or when prices change.
• The Ministry of Health will publicly post these prices so that people, healthcare facilities, and businesses can look up and compare.
• Organizations in the drug supply chain (import, distribution, retail) are required to declare prices of essential drugs for the Ministry of Health to monitor, analyze fluctuations, and prevent price manipulation.

Transitional provisions

• Drug registration applications submitted before July 1, 2025, can be processed under the 2016 Pharmacy Law if enterprises do not request application of the new law.
• Drug prices declared under the old law continue to be recognized until there are official changes under the new law.

Impact & recommendations for businesses

Impact

• Improved competitiveness and transparency in the pharmaceutical industry — especially for domestic manufacturing enterprises and FIEs.
• Enhanced access to medicines for people through e-commerce and reduced administrative barriers.
• New regulations on clinical trials, marketing authorization renewal, drug price control... help ensure stability and feasibility in business operations.

Recommendations for adaptation

• Businesses should review their internal processes: drug registration, clinical trials, drug distribution, to ensure compliance with new requirements.
• Invest in infrastructure for online sales, electronic quality management, information systems to protect consumers and comply with new regulations.
• Learn about new benefits for foreign-invested enterprises, take advantage of opportunities for raw material import, distribution of domestically manufactured drugs.
• Closely monitor the implementation schedule of the new Law and enforcement guidelines to decide the right timing for application submissions (if more beneficial).

Useful links to industries requiring strict production environments

In many industries such as pharmaceuticals, electronics, food and healthcare, production in clean environments (cleanroom) is mandatory to ensure quality, safety and comply with international standards. If your business needs to implement cleanrooms, consider the following factors:

• Design and construction of cleanrooms meeting GMP, ISO standards
• Environmental control, pressure, air cleanliness
• Choose reputable, experienced construction contractors

You can refer to Anh Khang Cleanroom's cleanroom construction services to learn about construction processes, standards, and practical solutions for cleanroom projects.

ANH KHANG CLEANROOM MECHANICAL & ELECTRICAL JOINT STOCK COMPANY Hotline: 1900 636 814 - 0902 051 222 Email: info@akme.com.vn Website: akme.com.vn Add: Lot B7 - Xuan Phuong Garden - Phuong Canh - Nam Tu Liem - Hanoi.