Circular 32: Vietnam’s regulations on reporting monitoring carried out by pharmaceutical-trading establishments

08:57, 15/11/2018

This is a notable content specified in Circular No. 32/2018/TT-BYT of the Ministry of Health of Vietnam on marketing authorization of drugs and medicinal ingredients.

According to Article 5 of Circular No. 32/2018/TT-BYT of the Ministry of Health of Vietnam, pharmaceutical-trading establishments and health facilities shall monitor, collect information, and submit reports to competent authorities on post-vaccination reactions and adverse reaction of the drug in accordance with Article 77 and Article 78 of the Law on Pharmacy of Vietnam, guidelines for Good Pharmacovigilance Practices, national guidelines for pharmacovigilance and relevant regulations.

bao cao theo doi cua co so kinh doanh duoc, CS kham chua benh, Thong tu 32/2018/TT-BYT

Illustration (Internet)

Moreover, the authorization holders shall submit reports on safety and efficacy of the drugs specified in Clause 2 Article 8 of this Circular (Form No. 2A/TT for drugs or 2B/TT for vaccines):

- to DI&ADR every 6 months throughout the effective period of the marketing authorization.

- when applying for renewal of the marketing authorization at Drug Administration of Vietnam.

Circular No. 32/2018/TT-BYT emphasizes that health facilities using the drugs specified in Clause 2 Article 8 of this Circular shall submit the report on the use of drugs (Form No. 2C/TT) to DI&ADR every 6 months throughout the effective period of the marketing authorization.

Other provisions can be found in Circular No. 32/2018/TT-BYT of the Ministry of Health of Vietnam, which takes effect from September 01, 2019.

Thu Ba

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