Circular No. 9/2020/TT-BYT amending the Circular No. 03/2018/TT-BYT

CIRCULAR

On amending and supplementing the Circular No. 03/2018/TT-BYT dated February 09, 2020 of the Minister of Health on good distribution practices for drugs and drug materials

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

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017, detailing a number of articles of and providing measures for implementing the Pharmacy Law;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018, on amendments to some articles related to business conditions under the state management of the Ministry of Health;

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

At the request of the Director of the Drug Administration of Vietnam;

The Minister of Health hereby promulgates the Circular on amending and supplementing the Circular No. 03/2018/TT-BYT dated February 09, 2020 of the Minister of Health on good distribution practices for drugs and drug materials.

Article 1. Amending and supplementing the Circular No. 03/2018/TT-BYT dated February 09, 2020 of the Minister of Health on good distribution practices for drugs and drug materials

1. To amend the introduction in Clause 1, Article 5 as follows:

“A dossier used as basis for evaluation of the compliance with GDP principles by a distributing establishment is the dossier of request for grant of certificate of eligibility for pharmaceutical business (the distributing establishment shall not be required to submit an additional dossier for the evaluation of the compliance with GDP principles because such dossier has been submitted when requesting for grant of certificate of eligibility for pharmaceutical 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, detailing a number of articles of and providing measures for implementing the Pharmacy Law (hereinafter referred to as the Decree No. 54/2017/ND-CP). For the establishment that distributes drugs and drug materials, it is required to carry out special control according to Article 38 of the Law on Pharmacy, Article 49 of the Government’s Decree No. 54/2017/ND-CP and Clause 31, Article 5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018, on amendments to some articles 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 for receiving and appraising dossiers: To comply with Clauses 2 and 5, Article 33, Article 49 of the Decree No. 54/2017/ND-CP and Clause 12, Article 5 of the Decree No. 155/2018/ND-CP.”

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

“dd) Step 5. Preparing and signing the record:

The evaluation team shall be responsible for preparing a record on evaluation of the compliance with GDP principles according to Form No. 03 provided in Appendix IV attached to this Circular. Such record must classify the level of compliance with GDP principles by the distributing establishment as prescribed in Clauses 2 and 3 of this Article, and list, analyze deficiencies (if any); including assenting and dissenting opinions of the evaluation team and the distributing establishment.

The evaluation record shall be signed and certified by the head of the distributing establishment and leader of the evaluation team. The evaluation record must include contents describing the composition of the evaluation team, location, time and extent of evaluation, and is made into 02 copies: 01 copy shall be kept by the distributing establishment and another shall be kept at the Department of Health.”

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