Circular No. 09/2020/TT-BYT amends and supplements Circular No. 03/2018/TT-BYT dated February 9, 2018, of the Minister of Health on good distribution practices for drugs and medicinal ingredients.

CIRCULAR

Amending and supplementing certain articles of Circular No. 03/2018/TT-BYT dated February 9, 2018, issued by the Minister of Health on good distribution practices for pharmaceutical products and active pharmaceutical ingredients

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Pursuant to Law No. 105/2016/QH13 dated April 6, 2016 on pharmaceuticals;

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

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

At the proposal of the Director of the Drug Administration Department, Ministry of Health,

The Minister of Health issues this Circular to provide for the amendment and supplementation of Circular No. 03/2018/TT-BYT dated February 9, 2018, issued by the Minister of Health on good distribution practices for pharmaceutical products and active pharmaceutical ingredients.

Article 1. Amending and supplementing certain articles of Circular No. 03/2018/TT-BYT dated February 9, 2018, issued by the Minister of Health on good distribution practices for pharmaceutical products and active pharmaceutical ingredients

1. Clause 1, Article 5 shall be amended as follows:

"The dossier serving as the basis for evaluating compliance with GDP for a distribution facility is the application dossier for the Drug Business License (submitted when applying for the Drug Business License, the distribution facility does not need to submit additional dossiers for GDP compliance evaluation) implemented according to Article 38 of the Drug Law and Article 32 of Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government detailing some provisions and measures to implement the Drug Law (hereinafter referred to as Decree No. 54/2017/NĐ-CP). For distribution facilities dealing with pharmaceutical products and active pharmaceutical ingredients subject to special control, it shall be carried out according to Article 38 of the Drug Law, Article 49 of Decree No. 54/2017/NĐ-CP, and Clause 31 of Article 5 of Decree No. 155/2018/NĐ-CP dated November 12, 2018, of the Government amending and supplementing some relevant provisions related to investment and business conditions under the management of the Ministry of Health (hereinafter referred to as Decree No. 155/2018/NĐ-CP)."

2. Clause 2, Article 6 shall be amended as follows:

"2. Procedure for receiving and examining the dossier: Implemented according to Clause 2 and Clause 5 of Article 33, Article 49 of Decree No. 54/2017/NĐ-CP and Clause 12 of Article 5 of Decree No. 155/2018/NĐ-CP."

3. Point đ Clause 1 Article 7 is amended as follows:

"đ) Step 5. Draft and sign the minutes:

The assessment team is responsible for drafting the GDP Assessment Minutes according to Model No. 03 stipulated in Appendix IV attached hereto; the minutes must classify the level of GDP compliance of the distribution facility according to Clause 2 and Clause 3 of this Article and list and analyze the deficiencies that the distribution facility needs to rectify (if any); the contents agreed upon and not agreed upon between the assessment team and the distribution facility.

The GDP Assessment Minutes are signed and confirmed by the Head of the Distribution Facility and the Leader of the Assessment Team. The minutes must reflect the composition of the assessment team, location, time, scope of assessment, and be drafted in two copies: one copy retained at the distribution facility, one copy retained at the Department of Health."

4. Clause 1, Article 8 shall be amended as follows:

"1. In case the GDP Assessment Minutes conclude that the distribution facility complies with GDP as prescribed in point a Clause 2 of Article 7 of this Circular:

Within ten days from the date of completion of the actual assessment at the distribution facility and signing the assessment minutes, the Department of Health shall issue the Drug Business License and/or the GDP Compliance Certificate according to Model No. 06 stipulated in Appendix IV attached hereto."

5. Point a and point c, Clause 2, Article 8 shall be amended as follows:

"a) Within five days from the date of completing the actual assessment at the distribution facility and signing the assessment minutes, the Department of Health shall send a letter requesting the distribution facility to rectify and correct the deficiencies recorded in the assessment minutes;

c) Within twenty days from the date of receipt of the report on rectification, the Department of Health shall evaluate the results of rectification by the distribution facility and conclude on the status of GDP compliance of the distribution facility:

- If the rectification by the distribution facility meets the requirements, the Department of Health shall issue the Drug Business License and/or the GDP Compliance Certificate according to Model No. 06 stipulated in Appendix IV attached hereto;

- If the rectification by the distribution facility does not meet the requirements, the Department of Health shall issue a reply stating the reasons for non-issuance."

"4. In case the distribution facility fails to submit the periodic assessment request dossier within the deadline prescribed in Clause 3 of this Article, within fifteen days from the due date for submission of the periodic assessment request dossier, the Department of Health shall issue a notice requiring the distribution facility to submit the periodic assessment request dossier."

"5. Within forty-five days from the due date for submission of the periodic assessment request dossier, if the distribution facility fails to submit the periodic assessment request dossier after this period, the Department of Health shall conduct an unscheduled assessment, inspection, and verification of the maintenance of GDP compliance of the facility according to Article 12 of this Circular."

8. Supplement Clause 7a to Article 9 as follows:

"7a. The distribution facility shall submit one set of the periodic assessment request dossier for maintaining GDP compliance along with the examination fee as prescribed by the Ministry of Finance regarding the examination fee for distribution conditions and standards of pharmaceutical products and active pharmaceutical ingredients to the Department of Health."

9. Supplementing point d to Clause 2 Article 12 as follows:

"c) The distribution facility provides explanations for non-compliance or fails to submit a report explaining the reasons for not submitting the periodic assessment request dossier as required by the Department of Health."

10. Point c Clause 2 Article 13 is amended as follows:

"c) Has been trained and instructed on GDP, GDP audit, and understands the principles and standards of GDP"

"14.11. By January 1, 2021, pharmaceutical distribution facilities must have internet-connected equipment and computers and manage pharmaceutical distribution activities through computer software, ensuring network connection and controlling origin, price, and source of purchased and sold drugs. There must be a mechanism for transferring information about drug purchases and sales, drug quality between suppliers and customers, as well as transferring information to relevant authorities when requested."

12. Supplementing Section 7.11 in Appendix 2 as follows:

"7.11. By January 1, 2021, distribution facilities dealing with active pharmaceutical ingredients must have internet-connected equipment and computers and manage distribution activities through computer software, ensuring network connection and controlling origin, price, and source of purchased and sold active pharmaceutical ingredients. There must be a mechanism for transferring information about active pharmaceutical ingredient purchases and sales, active pharmaceutical ingredient quality between suppliers and customers, as well as transferring information to relevant authorities when requested."

Article 2. Effective Date.

This Circular takes effect 45 days from the date of issuance.

During implementation, if there are difficulties or obstacles, please report them to the Ministry of Health for consideration and resolution./.