On 21 November 2024, the National Assembly passed and promulgated the Law on amendments to the Law on Pharmacy No. 44/2024/QH15 (“Amended Law on Pharmacy 2024”), to amend and supplement the Law on Pharmacy No. 105/2016/QH13 (“Law on Pharmacy 2016”). The Amended Law on Pharmacy 2024 will take effect on 01 July 2025, providing a boost to the current pharmaceutical industry in Vietnam.
In this article, BLawyers Vietnam presents three key updates recorded in the Amended Law on Pharmacy 2024, helping pharmacy business establishments better understand the important changes in the pharmaceutical sector in Vietnam.
1. Prohibited acts
According to the Amended Law on Pharmacy 2024, certain prohibited acts under the current regulations have been modified to align with pharmacy business activities, including the following acts:
- Running a pharmacy business at a location not specified in the Certificate of eligibility for pharmacy business or other location not authorized by the competent state authority, except for an e-commerce method;
- Wholesaling prescription drugs at prices higher than the announced or re-announced wholesale prices; wholesaling or retailing drugs at prices higher than the listed prices; and
- Practicing in positions specified in Article 11 of the Law on Pharmacy 2016 without a Pharmacy practice certificate or practicing beyond the scope of professional activities stated in the Pharmacy practice certificate or practicing during the period of suspension of the Pharmacy practice certificate.
In addition, the Amended Law on Pharmacy 2024 officially adds prohibitions on the following specific acts:
- Retailing by e-commerce the following drugs:
- Prescription drugs, except for cases of medical quarantine for infectious diseases in Group A that have been declared an epidemic according to the Law on prevention and control of infectious diseases;
- Controlled drugs; and
- Drugs on the List of drugs restricted from retailing.
- Wholesaling by e-commerce for controlled drugs; and
- Trading in drugs, medicinal ingredients by e-commerce through means other than e-commerce trading floor, sales e-commerce applications, and websites (or e-commerce website) having an online ordering function.
2. Chain pharmacy business model
The Amended Law on Pharmacy 2024 has added regulations regarding the chain pharmacy business model, specifically as follows:
- The chain pharmacy is a system of pharmacies operated by a chain pharmacy organization, operating under a unified quality control system under the same trade name;
- The chain pharmacy organization must meet the Good Distribution Practice (“GDP”) requirements of the wholesale drug and medicinal ingredients establishment. It must have at least 02 affiliated pharmacies that have been granted the Certificate of eligibility for pharmacy business and a unified quality control system to apply to pharmacies in the chain to be granted the Certificate of eligibility for pharmacy business.
In addition, the rights of chain pharmacy organizations are stipulated in the Amended Law on Pharmacy 2024 as follows:
- Rights of pharmacy business establishments according to the Law on Pharmacy 2016;
- Purchasing medicinal ingredients to transfer to pharmacies in the chain pharmacy for compounding prescription drugs and selling these drugs at the pharmacy where they were compounded;
- Purchasing drugs to transfer to pharmacies in the chain pharmacy for retail sale, except for vaccines. In the case of purchasing controlled drugs and drugs on the List of drugs restricted from retailing, complying with and meeting the business conditions for controlled drugs and drugs on the List of drugs restricted from retailing;
- Transferring drugs between the drug storage warehouse of the chain pharmacy organization and the pharmacies, and between pharmacies in the chain pharmacy, except for compounded prescription drugs. The transfer of drugs is coordinated by the chief pharmacist of the chain pharmacy organization; and
- Transferring the chief pharmacist among the pharmacies in the chain pharmacy organization.
3. Conduct of pharmaceutical business through an e-commerce method
Along with the chain pharmacy business model, the Amended Law on Pharmacy 2024 has added regulations on trading drugs and medicinal ingredients by an e-commerce method. Specifically, the business activities of trading in drugs and medicinal ingredients will include trading activities of drugs and medicinal ingredients by an e-commerce method on an e-commerce trading floor, sales e-commerce applications, or e-commerce website with an online ordering function.
In addition to the provisions of the Law on Pharmacy 2016 regarding the rights and responsibilities of pharmacy business establishments, if the pharmacy business establishment engages in an e-commerce method, that pharmaceutical business establishment will have the following rights and responsibilities:
- Complying with the provisions of the law on electronic transactions, law on e-commerce, law on advertising, law on consumer protection and other relevant laws;
- Ensuring the confidentiality of buyer information as prescribed by law;
- Posting full information about the Certificate of eligibility for pharmacy business, Pharmacy practice certificate of the chief pharmacist of the pharmacy, and information about approved drugs as prescribed by the Government;
- Notifying the competent authority about conduct pharmaceutical business through e-commerce method as prescribed by the Minister of Health;
- Organizing online consultation and guidance on how to use drugs for drug buyers and arranging drug delivery to buyers as prescribed by the Minister of Health;
- Only retailing non-prescription drugs that are not controlled drugs and are not on the List of drugs restricted from retailing.
- Retailing prescription drugs as prescribed by the Minister of Health if medical quarantine for infectious diseases in Group A that have been declared an epidemic according to the Law on prevention and control of infectious diseases;
- Only wholesaling drugs and medicinal ingredients that are not controlled drugs;
- Complying with other Government regulations on wholesale drugs and medicinal ingredients, and retail drugs through an e-commerce method.
The above is not official advice from BLawyers Vietnam. If you have any questions or suggestions about the above, please contact us at info@blawyersvn.com. BLawyers Vietnam would love to hear from you.
Date: 20 January 2025
Writer: Thai Bui
