Vietnam: Documents used as basis for inspection of GMP compliance by a pharmacy business establishment are those included in its application for certificate of eligibility for pharmacy business

According to Circular No. 35/2018/TT-BYT of the Ministry of Health of Vietnam, documents used as basis for inspection of GMP compliance by a pharmacy business establishment are those included in its application for certificate of eligibility for pharmacy business. Manufacturers of special-controlled pharmaceutical products must have the documents prescribed in Article 38 of the Law on Pharmacy of Vietnam and Clause 31 Article 5 of Decree No. 155/2018/NĐ-CP of Vietnam’s Government.

Besides, Circular No. 35/2018/TT-BYT also provides guidance for implementing the above-mentioned regulations, specifically as follows:

- If a manufacturer applies for both certificate of GMP compliance and certificate of eligibility for pharmacy business, this content and applied GMP principles must be clearly specified in its application form for certificate of eligibility for pharmacy business.

- If the manufacturer applying for certificate of eligibility for pharmacy business sells pharmaceutical products and pharmaceutical starting materials to wholesalers, retailers or health facilities, documents about its technologies and personnel according to Clause 2 Article 32 of Decree No. 54/2017/ND-CP are required when it applies for both certificate of GDP compliance and certificate of eligibility for pharmacy business. The receiving authority shall inspect its compliance with both GDP and GMP in accordance with regulations on GDP.

View more details at Circular No. 35/2018/TT-BYT of the Ministry of Health of Vietnam, effective from January 10, 2019.

- Thanh Lam -

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE