Vietnam: 08 changes that the manufacturer shall apply for the certificate of eligibility for pharmacy business

08:57, 04/01/2019

The Ministry of Health of Vietnam issued Circular No. 35/2018/TT-BYT on Good Manufacturing Practices (GMP) for pharmaceutical products and pharmaceutical starting materials.

According to Circular No. 35/2018/TT-BYT of the Ministry of Health of Vietnam, after making any change, the manufacturer shall apply for the certificate of eligibility for pharmacy business or submit a report on its change if:

- making one of the changes specified in Point b Clause 1 Article 36 of the Law on Pharmacy of Vietnam; or

- changing the location of a factory at the same business location; or

- opening a new factory at the same business location; or

- expanding existing factory; or

- repairing or having significant changes in structure and floor plan of the premises and production line, which results in changes to environmental conditions and manufacturing process; or

- changing important manufacturing equipment, thereby affecting manufacturing process and quality of pharmaceutical products and pharmaceutical starting materials; or

- changing auxiliary system or principle of designing and operating utility systems, thereby affecting manufacturing environment; or

- changing applied GMP and undergoing inspection of compliance with EU - GMP or equivalent (Japan - GMP, US - Current GMP, PIC/S -GMP) by an SRA and being recommended by an SRA to make the declaration of compliance with GMP.

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

- Thanh Lam -

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