Vietnam: What are the regulations concerning pharmacovigilance activities?

Vietnam: What are the regulations concerning pharmacovigilance activities? (Illustrative image)

In Article 77 of the Law on Pharmacy 2016, the specific pharmacovigilance activities in Vietnam include:

- Monitoring, discovering, notifying adverse effects of drugs, drug-related errors, suspected counterfeit drugs, unqualified drugs, and information about ineffective drugs;

- Collecting, processing information mentioned in Point a of this Clause; assessing the benefits, risks, making conclusion and managing drug-related risks;

- Announcing conclusions of competent authorities about drug safety.

Any drug user who has unusual signs while using drugs must directly notify his/her physician or drug retailer where the drug was sold, and visit a health facility for prompt treatment.

Medical practitioners in Vietnam have the responsibilities to:

- Monitor, discover unusual signs, drug-related errors, suspicious drug quality and efficacy in their practice;

- Take actions and precautious measures when finding unusual signs or errors or when receiving information from drug users as prescribed in Clause 2 of this Article;

- Notify a competent authority of information collected while performing the tasks specified in Point a and Point b of this Clause.

Drug retailers have the responsibility to counsel drug users to deal with unusual signs shown during the use of drugs and collect information about unusual signs shown during the use of drugs and notify a competent authority.

Manufacturers and applicants for drug registration have the responsibility to organize the monitoring of quality, safety, and efficacy of drugs when they are put on the market; update competent authorities on information about quality, safety, and efficacy of drugs they produce, prepare, or register.

Detailed information may be found in the Law on Pharmacy 2016 effective from January 1, 2017.

Ty Na

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