CIRCULAR

AMENDMENTS TO THE CIRCULAR NO. 04/2018/TT-BYT DATED FEBRUARY 09, 2018 OF THE MINISTER OF HEALTH ON GOOD LABORATORY PRACTICE

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 on guidelines for implementation of the Law on Pharmacy;

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 state management of the Ministry of Health;

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

At the request of the Director General of Drug Administration of Vietnam,

The Minister of Health hereby promulgates a Circular on amendments to the Circular No. 04/2018/TT-BYT dated February 09, 2018 of the Minister of Health on Good Laboratory Practice.

Article 1. Amendments to the Circular No. 04/2018/TT-BYT dated February 09, 2018 of the Minister of Health on Good Laboratory Practice

1. Clause of Article 5 is amended as follows:

“Documents used as basis for inspection of compliance with GLP by a test facility are those included in its application for certificate of eligibility for pharmacy business (the test facility is not required to submit these documents because they have been submitted when it applies for the certificate of eligibility for pharmacy business) 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 the implementation of the Law on Pharmacy (hereinafter referred to as “the Decree No. 54/2017/ND-CP”). In the case of a controlled drug test facility, the documents 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 the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health (hereinafter referred to as “the Decree No. 155/2018/ND-CP”) are required to be submitted.

The technical documents about the test facility shall be prepared in accordance with guidelines for the site master file provided in the Appendix III hereof or the site master file that is updated in case of change of scope of operation”.

2. Clause 2 of Article 6 is amended as follows:

“2. Procedures for receiving and inspecting an application are specified in:

a) Clauses 2 and 5 Article 33 of the Decree No. 54/2017/ND-CP and Clause 12 Article 5 of the Decree No. 155/2018/ND-CP;

b) Regulations on Good Clinical Practice, applicable to providers of bioequivalence study services.”

3. Clause 4 of Article 9 is amended as follows:

“4. In case the test facility fails to submit the application for periodic inspection by the aforementioned deadline, within 15 days from the deadline for submission of the application, the Drug Administration of Vietnam shall request the test facility in writing to submit the application for periodic inspection.”

4. Clause 5 of Article 9 is amended as follows:

“5. Within 45 days from the deadline for submission of the application for periodic inspection, after the said time limit ends, if the test facility fails to submit the application for periodic inspection, the Drug Administration of Vietnam shall carry out an unscheduled inspection, audit and inspection of GLP compliance by the test facility as prescribed in Article 12 hereof.”

5. Clause 7a is added to Article 9 as follows:

 “7a. The test facility shall submit 01 application for periodic inspection of GLP compliance and pay assessment fees according to regulations of the Minister of Finance on fees for assessment of good laboratory practice for drugs to the Drug Administration of Vietnam - the Ministry of Health.”

6. Point dd is added to Clause 2 of Article 12 as follows:

“dd) The test facility provides inappropriate explanation or fails to provide explanation for its failure to submit the application for periodic inspection at the request of the Drug Administration of Vietnam.”.

7. Section 7 in the Appendix III Site master file is amended as follows:

“7. Complaints and test result invalidation

7.1. Handling complaints

Brief description of the system for handling complaints.

7.2. Test result invalidation

Brief description of the system for invalidating test results”.

8. Form No. 03 GLP inspection report and Form No. 04 Certificate of GLP compliance in the Appendix V are amended according to the Appendix hereof.

Article 2. Effect

This Circular comes into force 45 days after the date on which it is promulgated.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration and resolution./.

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