Vietnam: Documents used as basis for inspection of fulfillment of good pharmacy practice (GPP) requirements

Recently, the Ministry of Health of Vietnam has issued the Circular No. 12/2020/TT-BYT providing amendments to the Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on good pharmacy practice.

According to Clause 1 Article 1 of the Circular No. 12/2020/TT-BYT and Article 5 of the Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam, documents used as the basis for an inspection of fulfillment of GPP requirements by a pharmacy are those included in its application for Certificate of eligibility for pharmacy business (the pharmacy is not required to submit these documents because they have been submitted when the pharmacy applies for the Certificate of eligibility for pharmacy business) as prescribed in Article 38 of the Law on pharmacy and Article 32 of Decree No. 54/2017/NĐ-CP of Vietnam’s Government dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy. A pharmacy that sells controlled drugs shall comply with the provisions in Article 38 of the Law on pharmacy, Article 49 of Decree No. 54/2017/NĐ-CP.

Technical documents of a pharmacy include:

- The organizational chart, list of employees, names, positions and qualifications of employees;

- The layout plan displaying all areas of a pharmacy;

- The list of equipment (including information concerning computer system and management software);

- The list of regulations, dossiers, documentation system and standard operating procedure (SOP);

- The complete GPP checklist made according to the form stated in the Appendix II 2a or 2b or 2c enclosed with Circular No. 02/2018/TT-BYT.

If a pharmacy applies for both GPP Certificate and Certificate of eligibility for pharmacy business, this content must be clearly specified in its application form for Certificate of eligibility for pharmacy business.

View more details at Circular No. 12/2020/TT-BYT of the Ministry of Health of Vietnam, effective from August 06, 2020.

Thu Ba


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