Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam was issued on January 22, 2018, providing guidelines for Good Pharmacy Practices (GPP).
Appendixes on new GPP standards applied for drugstores and dispensaries nationwide are enclosed with Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam, to be specific:
- Drugstores apply and maintain GPP standards for drugstores specified in the Appendix I – 1a enclosed herewith.
- Dispensaries apply and maintain GPP standards for dispensaries specified in the Appendix I – 1b enclosed herewith.
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 as prescribed in Article 38 of the Law on Pharmacy 2016 of Vietnam and Article 32 of Decree No. 54/2017/NĐ-CP of Vietnam’s Government.
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;
- 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 herewith.
View more details at the Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam, effective from March 08, 2018, replacing Circular No. 46/2011/TT-BYT.
Address: | 19 Nguyen Gia Thieu, Vo Thi Sau Ward, District 3, Ho Chi Minh City |
Phone: | (028) 7302 2286 |
E-mail: | info@lawnet.vn |