What is GPP? Documents used as basis for inspection of fulfillment of GPP requirements in Vietnam

What is GPP? Documents used as basis for inspection of fulfillment of GPP requirements in Vietnam (Internet image)

LawNet would like to answer as follows:

1. What is GPP?

According to Clause 5, Article 2 of Circular 02/2018/TT-BYT, GPP” stands for the phrase “Good Pharmacy Practices”, which means “Thực hành tốt cơ sở bán lẻ thuốc” in Vietnamese..

According to Clause 1, Article 2 of Circular 02/2018/TT-BYT, Good Pharmacy Practice means a set of principles and standards for practice at drug retailers (or pharmacies) with the aims of ensuring and improve the direct supply and retailing of safe and effective drugs to patients.

2. Documents used as basis for inspection of fulfillment of GPP requirements in Vietnam

According to the provisions of Article 5 of Circular 02/2018/TT-BYT, documents used as the basis for an inspection of fulfillment of GPP requirements by a pharmacy are those included in its application for Certificate of eligibility for pharmacy business (the pharmacy is not required to submit these documents because they have been submitted when it applies for the Certificate of eligibility for pharmacy business) as prescribed in Article 38 of the Law on Pharmacy 2016 and Article 32 of the Decree 54/2017/ND-CP

If a pharmacy trades in controlled drugs, it must have the documents prescribed in Article 38 of the Law on Pharmacy 2016 and Article 49 of the Decree 54/2017/ND-CP.

Technical documents of a pharmacy include:

- The organizational chart, list of employees, names, positions and qualifications of employees;

- The layout plan displaying all areas of a pharmacy;

- The list of equipment (including information concerning computer system and management software);

- The list of regulations, dossiers, documentation system and standard operating procedure (SOP);

- The complete GPP checklist made according to the form stated in the Appendix II 2a or 2b or 2c enclosed with Circular 02/2018/TT-BYT.

If a pharmacy applies for both GPP Certificate and Certificate of eligibility for pharmacy business, this content must be clearly specified in its application form for Certificate of eligibility for pharmacy business.

3. Procedures for receiving and appraising an application for inspection compliance with GPP in Vietnam

According to Clause 2, Article 6 of Circular 02/2018/TT-BYT, procedures for receiving and appraising an application for inspection shall be performed according to:

- Regulations in Clauses 2, 3, 4, 5 and 6 Article 50 of the Decree 54/2017/ND-CP if the applicant is a pharmacy trading in combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors; or

- Regulations in Clauses 2, 3, 4 and 5 Article 51 of the Decree 54/2017/ND-CP if the applicant is a pharmacy trading in toxic drugs, toxic medicinal ingredients, drugs and active ingredients on the list of banned substances in certain fields; or

- Regulations in Clauses 2, 4 and 5 Article 33 of the Decree 54/2017/ND-CP if the applicant is a pharmacy other than the ones prescribed in Point a and Point b of this Clause.

4. Determination of degrees of fulfillment of GPP requirements in Vietnam

According to Clause 3, Article 7 of Circular 02/2018/TT-BYT, Determination of degrees of fulfillment of GPP requirements is as follows:

- The pharmacy is considered to have complied with GPP requirements if it has no criterion given the “non-compliance” points and achieves at least 90% of total points;

- The pharmacy is required to submit report on corrective actions taken if it has no criterion given the “non-compliance” points and achieves from 80% to under 90% of total points;

- The pharmacy fails to comply with GPP requirements if it has any criteria given the "non-compliance" points or achieves less than 80% of total points.

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