Vietnam’s Circular No. 02/2018/TT-BYT: Rights and responsibilities of an inspection team

Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam was issued on January 22, 2018, providing guidelines for Good Pharmacy Practices (GPP). This Circular specifies the rights and responsibilities of an inspection team conducting inspections of fulfillment of GPP requirements by pharmacies.

Specifically, according to the Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam, responsibilities of the inspection team are as follows:

- Inspect all drug retailing activities on the basis of corresponding GPP standards specified in Article 3 herein and relevant specialized regulations; clearly record inspection contents, deficiencies found and make GPP inspection report;

- Submit inspection report or written explanation about GPP inspection report in case the pharmacy has any disagreements with the GPP inspection report;

- Maintain confidentiality of information concerning the inspection and drug retailing activities of the pharmacy, except the case where such information is provided with the consent of the pharmacy or at the request of a competent authority.

In addition to responsibilities, the inspection team also has the following rights:

- Inspect all areas, facilities and equipment of the pharmacy, and have the rights to request for inspection of other areas related to the drug retailing or concoction of the pharmacy;

- Request the pharmacy to provide documents concerning its business, quality management and drug retailing;

- Collect documentary evidences (take photocopies of documents, photographs and make videos) of any deficiencies found during the inspection;

- Take samples of medicines to test their quality as regulated by law.

- Make an inspection report and request the pharmacy to suspend its operation if the inspection team detects any violations which may cause adverse effects on the quality of one or some medicine products; request the competent official to make official decision on handling of violations.

This is the content of Article 14 of the Circular No. 02/2018/TT-BYT of the Ministry of Health of Vietnam, effective from March 08, 2018.


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