Key takeaways
Below are key issues under Decree 163 and Circular 31 that may impact the business operations of pharmaceutical companies in Vietnam:
- Pharmaceutical business via e-commerce
- Pharmaceutical businesses operating via e-commerce platforms must upload/publish the following: (i) Certificate of Satisfaction for Conditions of Pharmaceutical Trading Business (CSC); (ii) Pharmaceutical Practicing Certificate of the person in charge of pharmaceutical expertise; and (iii) drug information (including marketing authorization (MA)/import license and other relevant details).
- For drugs sold via e-commerce platforms, the packaging of products delivered to customers must include specific mandatory information, including the following:
- For end-users: (i) the name, address and phone number of the customer; and (ii) phone number of the salesperson
- For wholesalers: the number and date of issuance of the wholesaler's CSC.
- Drug advertising
Under the previous regulations, the Drug Advertising Content Confirmation Certificate (DACCC) was required when the MA holder changed. Decree 163 removes this requirement, allowing for an amendment to the existing DACCC.
- Shelf-life of imported pharmaceutical and medicinal ingredient
Decree 163 introduces new requirements regarding the shelf-life of imported drugs and medicinal ingredients at the time of customs clearance, including the following:
- For drugs and medicinal ingredients with a total shelf-life of nine months or less, their remaining shelf-life at the time of customs clearance must be at least one-third of the total duration.
- For drugs and medicinal ingredients with a total shelf-life of 30 days or less, they must have a valid remaining shelf-life at the time of customs clearance.
- Announcement and re-announcement of drug price
Decree 163 provides more detailed regulations regarding drug price announcements, particularly as follows:
- The expected wholesale price must be announced to the Ministry of Health (MOH) after the drug is granted an MA or import license, and before the importer dispatches the first lot to the market. The importer is not required to announce the expected wholesale price for subsequent lots or shipments if there is no price adjustment compared to the announced expected wholesale price.
- The drug importer may submit the table of announcement/re-announcement of expected wholesale price via direct submission, post-delivery or online to the MOH. It takes one working day for the MOH to issue the receipt of expected wholesale price from the date of submission.
- The following categories of drugs are exempt from the price announcement requirement:
- Free-of-charge drugs and vaccines used for urgent national defense, disaster response, and disease prevention and control
- Drugs under state-run health programs
- Aid and humanitarian aid drugs
- Drugs used for clinical trials, bioequivalence testing, bioavailability assessment, registration samples, testing samples and scientific research
- Drugs carried in personal luggage to be displayed at exhibitions and fairs
- Drug information activities
Decree 163 and Circular 31 remove the requirement to obtain confirmation of drug information content. Any such information issued before 1 July 2025 shall remain valid until the end of its stated validity period.
1 Law No. 44/2024/QH15, which amends certain articles of the Pharmaceutical Law, was issued on 21 November 2024.
