Tiếng Việt
中文Short answer: The dossier for a Certificate of Satisfaction of Pharmaceutical Business Conditions for a private drug counter includes: an application for the Certificate; technical documents on the location, storage areas, equipment, professional-technical expertise, and personnel in accordance with Good Pharmacy Practice (GPP) principles for drug retail establishments; and the establishment’s relevant legal papers. The dossier is submitted to the Director of the Department of Health (the authority competent to issue for drug retail establishments including drug counters); the issuance time limit is 30 days from the date of receipt of a complete and valid dossier.
Note on the new legal framework: From 1 July 2025, Law No. 44/2024/QH15 (amending and supplementing the Law on Pharmacy No. 105/2016/QH13) takes effect, together with Decree No. 163/2025/ND-CP (29 June 2025) and Circular No. 31/2025/TT-BYT (1 July 2025) guiding implementation. Forms and dossier details should be checked against the new instruments.
Related services
Corporate Legal Advisory
If your company needs to review governance authority, resolutions, charter documents or internal dispute risk, ANT Legal can help assess the file and suggest appropriate next steps.
Legal basis
- Law on Pharmacy No. 105/2016/QH13 (as amended and supplemented by Law No. 44/2024/QH15, effective from 1 July 2025);
- Decree No. 163/2025/ND-CP detailing and guiding the implementation of the Law on Pharmacy;
- Circular No. 31/2025/TT-BYT of the Minister of Health.
Dossier for the Certificate of Satisfaction of Pharmaceutical Business Conditions for a drug counter
The basic dossier components include:
- An application for the Certificate of Satisfaction of Pharmaceutical Business Conditions (per the current form);
- Technical documents: documents on the location, storage areas, storage equipment, professional-technical expertise, and personnel in accordance with Good Pharmacy Practice (GPP) principles for drug retail establishments;
- Legal papers of the establishment (enterprise/business household registration certificate with an appropriate business line; pharmaceutical practice certificate of the professionally responsible person);
- Technical documents must be stamped by the establishment on the cover page and overlapping-sealed on the remaining pages; where the establishment has no seal, the legal representative’s signature is used.
Who issues the Certificate for a drug counter? How long does it take?
- Authority: the Director of the Department of Health issues, re-issues, adjusts, and revokes Certificates of Satisfaction of Pharmaceutical Business Conditions for drug retail establishments, including pharmacies, drug counters, commune health station medicine cabinets, and establishments specializing in retail of medicinal materials, herbal medicines, and traditional medicines;
- Time limit: 30 days from the date of receipt of a complete application dossier; 20 days for re-issuance or adjustment; 07 working days for re-issuance due to the issuing authority’s error;
- Validity: the Certificate of Satisfaction of Pharmaceutical Business Conditions has no prescribed validity period, but the establishment must maintain compliance with the conditions and periodically assess GPP compliance.
Frequently asked questions
May a drug counter sell prescription drugs?
A drug counter may sell prescription drugs within the permitted scope when the buyer has a valid prescription and complies with professional regulations; it may not sell beyond the scope stated on the certificate.
May the old certificate be reused after relocating a drug counter?
No. The new location must satisfy GPP conditions, and the establishment must complete the procedure for adjusting/re-issuing the Certificate with the Department of Health before operating at the new location.
To prepare a compliant drug counter dossier correctly from the outset, you should contact ANT Legal’s lawyers at 0966.475.966 for review and advice before proceeding.
