Vietnam: Periodic inspection of maintenance of fulfillment of GPP requirements

Specifically, according to Article 9 of the Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam, the application for periodic inspection of maintenance of fulfillment of GPP requirements includes:

- The application form for periodic inspection of maintenance of fulfillment of GPP requirements;

- Technical documents indicating changes in facilities, equipment and personnel of the pharmacy (if any);

- The brief report on operating results of the pharmacy for the last three years from the date of previous inspection (except unexpected inspections or audits by the Ministry of Health or the Provincial Department of Health) to the date of this periodic inspection.

Regulations on periodic inspection of maintenance of fulfillment of GPP requirements is as follows:

- The maintenance of fulfillment of GPP requirements by a pharmacy must be periodically inspected for every 03 years from the end of the previous inspection (except unexpected inspections or audits by the Ministry of Health or the Provincial Department of Health).

- Every Provincial Department of Health, in November every year, shall publish the plan for periodic inspection of pharmacies’ maintenance of fulfillment of GPP requirements in the following year on its website.

- Based on the plan for periodical inspection published by the Provincial Department of Health, the relevant pharmacy, at least 30 days prior to the estimated date of inspection specified in such plan, must submit an application for periodical inspection as prescribed in Clause 7 Article 9 of Circular No. 02/2018/TT-BYT to the Provincial Department of Health.

E.g.: If the estimated date of inspection of the pharmacy A is on August 18, 2018, the pharmacy A is required to submit an application for inspection to the Provincial Department of Health by July 18, 2018.

- If a pharmacy fails to submit the application for periodic inspection within the time limit prescribed in Clause 3 Article 9 of Circular No. 02/2018/TT-BYT, it is required to provide a written explanation as requested in writing by the Provincial Department of Health.

- Within 30 days from the receipt of the Provincial Department of Health’s written request for explanation about its failure to submit the application for periodic inspection, if the pharmacy still fails to submit such application of periodic inspection as prescribed, the Provincial Department of Health shall revoke the Certificate of eligibility for pharmacy business issued to that pharmacy in accordance with regulations in Clause 2 Article 40 of the Law on Pharmacy of Vietnam.

- The pharmacy is allowed to continue its operations within the scope of operations permitted in the Certificate of eligibility for pharmacy business for the period from the date of submission of application for periodical inspection to the date of receipt of periodic inspection results.

View more details at the Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam, effective from March 08, 2018.

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