Circular No. 8/2020/TT-BYT amends and supplements Circular No. 04/2018/TT-BYT dated February 9, 2018, issued by the Minister of Health, concerning good laboratory practice.

CIRCULAR
Amending and supplementing certain Articles of Circular No. 04/2018/TT-BYT
dated February 9, 2018 of the Minister of Health
on Good Laboratory Practice (GLP).

^_________ 

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 Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions under the 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,

The Minister of Health issues this Circular stipulating the amendment and supplementation of Circular No. 04/2018/TT-BYT dated February 9, 2018 of the Minister of Health on Good Laboratory Practice (GLP).

Article 1. Amending and supplementing certain Articles of Circular No. 04/2018/TT-BYT dated February 9, 2018 of the Minister of Health on Good Laboratory Practice (GLP)

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

"The dossier serving as the basis for evaluating compliance with GLP for testing facilities is the application dossier for the Drug Business License (submitted when applying for the Drug Business License, testing facilities do not need to submit additional dossiers for GLP 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 testing facilities for specially controlled drugs, 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 certain 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). Technical documents about testing facilities shall be presented according to the overall dossier guidance for testing facilities prescribed in Appendix III issued together with this Circular or the updated overall dossier in case of expanded scope of activities."

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

"2. The procedures for receiving and examining the dossier shall be implemented according to the provisions at:
a) Clause 2 and Clause 5 of Article 33 of Decree No. 54/2017/NĐ-CP and Clause 12 of Article 5 of Decree No. 155/2018/NĐ-CP; b) Provisions on Good Clinical Practice for biological equivalent drug testing service providers."

3. Clause 4 of Article 9 shall be amended as follows:

"4. In cases where testing facilities do not submit the dossier requesting periodic assessment within the time limit specified in Clause 3 of this Article, within 15 days from the date of the periodic assessment deadline, the Department of Drug Management shall issue a document requiring the testing facility to submit the dossier requesting periodic assessment."

4. Clause 5 of Article 9 shall be amended as follows:

"5. Within 45 days from the due date for submitting the dossier requesting periodic assessment, if the testing facility does not submit the dossier requesting periodic assessment after this period, the Department of Drug Management shall conduct an unscheduled assessment, inspection, and examination of the maintenance of GLP compliance of the facility according to the provisions of Article 12 of this Circular."

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

"7a. Testing facilities submit one set of the dossier requesting periodic assessment of GLP maintenance along with the examination fee as prescribed by the Minister of Finance regarding the examination fee for standards and testing conditions to the Department of Drug Management - Ministry of Health."

6. Supplement Point d to Clause 2 of Article 12 as follows:

"d) Testing facilities provide explanations for non-compliance or fail to submit reports explaining reasons for not submitting the dossier requesting periodic assessment as required by the Department of Drug Management."

7. Item 7 of Appendix III Overall Dossier on Testing Facilities shall be amended as follows:

"7. Complaint handling and test result withdrawal 7.1. Complaint handling: Brief description of the system for handling complaints. 7.2. Test result withdrawal: Brief description of the system for handling the withdrawal of test results."

8. Amend Sample 03 GLP Assessment Report Form and Sample 04 Certificate Appendix V Model Documents attached to this Circular.

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 to the Ministry of Health for consideration and resolution./.