On 29 June 2025, the Vietnamese Government promulgated Decree No. 163/2025/ND-CP (“Decree 163”) as part of their revised Law on Pharmacy. Decree 163 came into effect on July 1, 2025, and makes overall revisions in the areas of pharmaceutical regulation, certification of pharmacy operation, business registration, import/export of medicines, GMP inspection, advertisements, recalls, and price management.
Key Regulatory Changes:
- Pharmaceutical E-commerce: Online sales of drugs have to make sure that their business eligibility certificate, pharmacist-in-charge license, and drug information are available on their websites for transparency and safety purposes.
- Import controls: All drugs with marketing authorization (MA) are now subject to import notification, with the exception of drugs for epidemic control or those with a less than 30-day shelf life. Importers must notify the provincial People’s Committee five working days in advance of the customs declaration.
- Corrections to Advertising: Decree 163 outlines a fast-track procedure to correct authorized certificates of drug advertising for minor adjustments, such as changes of the name of the MA holder or manufacturer, which do not require full re-registration.
- Drug Price Transparency: Companies are required to announce their wholesale prices and any changes made to these prices. The MOH will make suggestions publicly in cases where prices significantly surpass market comparables or international reference prices.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.