Thông tư 12/2020/TT-BYT sửa đổi Thông tư 02/2018/TT-BYT thực hành tốt cơ sở bán lẻ thuốc

CIRCULAR

On amending and supplementing a number of Article of the Circular No. 02/2018/TT-BYT dated May 04, 2018 of the Minister of health on good pharmacy practices

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Pursuant to the Law No. 105/2016/QH13 on Pharmacy dated April 06, 2016;

Pursuant to the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of and providing measures for implementation of the Pharmacy Law;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 amending and supplementing a number of business conditions under State management of the Ministry of Health;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 prescribing the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration of Vietnam,

The Minister of Health hereby issues the Circular on amending and supplementing a number of Article of the Circular No. 02/2018/TT-BYT dated May 04, 2018 of the Minister of health on good pharmacy practices.

Article 1. On amending and supplementing a number of Article of the Circular No. 02/2018/TT-BYT dated May 04, 2018 of the Minister of health on good pharmacy practices

1. The first paragraph of Clause 1 Article 5 as follows:

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 documents on good pharmacy practices 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 and Article 32 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy (hereinafter referred to as "Decree No. 54/2017/ND-CP”). For special control pharmacy, to implement as prescribed in Article 38 of the Law on Pharmacy, Article 49 of the Decree No. 54/2017/ND-CP and Clause 31 Article 5 of Decree No. 155/2018/ND-CP November 12, 2018 of the Government on amending and supplementing a number of regulations related to business conditions under the state management of the Ministry of Health (hereinafter referred to as the Decree No. 155/2018/ND-CP).

2. To amend Clause 2 Article 6 as follows:

“2. Order of dossier receipt and appraisal: Implement as prescribed in Clause 2 and Clause 5 of Article 33, Article 49 of the Decree No. 54/2017/ND-CP and Clause 12 Article of the Decree 155/2018/ND-CP.”

3. To amend point dd Clause 1 Article 7 as follows:

“dd) Step 5. Preparing and certifying inspection report:

The inspection team shall prepare the report on inspection of fulfillment of GPP requirements using the Form No. 02 stated in the Appendix III enclosed herewith; The inspection report must clearly specify the degree of fulfillment of GPP requirements by the pharmacy as prescribed in Clause 2 and Clause 3 of this Article, and deficiencies requiring corrective actions (if any); agreement and disagreements between the inspection team and the applicant after careful consideration of the complete checklist pursuant to relevant provisions for such type of pharmacy.

The inspection report must be certified by signatures of the pharmacy manager and the inspection team leader. The inspection report must include contents describing the composition of the inspection team, location, time and extent of inspection, and is prepared in two copies, 01 of which shall be kept by the Provincial Department of Health and the other is kept by the applicant.”

4. To amend Clause 1 Article 8 as follows:

“1. If the inspection report indicates that the pharmacy complied with GPP requirements as prescribed in Point a Clause 3 Article 7 herein:

Within 10 days from the completion of the site inspection and obtainment of a valid inspection report, the Provincial Department of Health shall issue the Certificate of eligibility for pharmacy business or GPP Certificate to the qualified pharmacy using the Form No. 03 stated in the Appendix III enclosed herewith.”

5. To amend point a and c of Clause 2 Article 8 as follows:

“a) Within 05 days from the completion of the site inspection at the pharmacy premises and obtainment of a valid inspection report, the Provincial Department of Health shall request the pharmacy in writing to take correction actions against its deficiencies specified in the inspection report;

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