Thông tư 09/2020/TT-BYT sửa đổi Thông tư 03/2018/TT-BYT thực hành tốt phân phối thuốc

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.”

4. To amend Clause 1, Article 8 as follows:

“1. In case the evaluation record indicates that the establishment distributing drugs complies with GDP principles under Point a, Clause 2, Article 7 of this Circular:

Within 10 days, after the last day of the field evaluation at the distributing establishment and after the evaluation record is signed, the Department of Health shall grant the certificate of eligibility for pharmaceutical business and/or grant the GDP certification according to Form No. 06 provided in Appendix IV attached to this Circular”.

5. To amend Points a and c, Clause 2, Article 8 as follows:

“a) Within 05 days from the date on which the field evaluation at the distributing establishment is completed and the date on which the evaluation record is signed, the Department of Health shall send a written request to the distributing establishment for remedying deficiencies stated in the evaluation record;

c) Within 20 days after receiving a remedy report, the Department of Health shall evaluate the remedy result and the compliance with GDP principles by the distributing establishment:

- If results of remedy actions make the distributing establishment satisfying the requirements, the Department of Health shall grant a certificate of eligibility for pharmaceutical business and/or grant a GDP certification according to Form No. 06 provided in Appendix IV attached to this Circular;

- If the distributing establishment still fails to satisfy requirements after remedying, the Department of Health shall send a written response, specifying reasons for rejecting.”

6. To amend Clause 4, Article 9 as follows:

“4. In case the distributing establishment fails to submit the dossier of request for periodic evaluation within the time limit specified in Clause 3 of this Article, within 15 days from the deadline for submitting dossiers of request for periodic evaluation, the Department of Health shall issue a written request to the distributing establishment for submission of such dossiers.”

7. To amend Clause 5, Article 9 as follows:

“5. Past 45 days from the deadline for submitting dossiers of request for periodic evaluation, if the distributing establishment fails to submit such dossier, the Department of Health shall carry out extraordinary evaluation, inspection and examination of the compliance with GDP principles of the establishment in accordance with Article 12 of this Circular.”

8. To add Clause 7a to Article 9 as follows:

“7a. The distributing establishment shall submit 01 set of dossier of request for periodic evaluation of the compliance with GDP principles, and pay appraisal charges to the Department of Health in accordance with the Ministry of Finance s regulations on charges for appraisal of conditions and standards for distribution of drugs and drug materials.”

9. To add Point d to Clause 2, Article 12 as follows:

“c) The distributing establishment makes inappropriate explanation or fails to explain reason for not submitting dossiers of requesting for periodic evaluation at request of the Department of Health.”

10. To amend Point c, Clause 2, Article 13 as follows:

“c) He/she has been trained in GDP, GDP inspection and evaluation and masters GPP principles and standards”

11. To amend Section 14.11, Appendix 1 as follows:

“14.11. By January 01, 2021, the establishment distributing drugs must be equipped with equipment and computers connected with Internet and manage the distribution of drugs by computer software, connect with Internet, and ensure the control of original and price of purchased and sold drugs. There should be the mechanism on transmitting information on drug purchase and drug quality between the distributor and customers, as well as the mechanism on transmitting information to the relevant management agency upon request.”

12. To add Section 7.11, Appendix 2 as follows:

“7.11. By January 01, 2021, the establishment distributing drug materials must be equipped with equipment and computers connected with Internet and manage the distribution by computer software, connect with Internet, and ensure the control of original and price of purchased and sold ones. There should be the mechanism on transmitting information on drug material purchase and drug material quality between the distributor and customers, as well as the mechanism on transmitting information to the relevant management agency upon request.”

Article 2. Effect

This Circular takes effect after 45 days from the date of its signing.

Any difficulties and problems arising in the course of implementation should be promptly reported to the Ministry of Health for consideration and settlement./.

* All Appendices are not translated herein.