Thông tư 36/2025/TT-BYT sửa đổi một số Điều về phân cấp của Thông tư 04/2018/TT-BYT quy định về Thực hành tốt phòng thí nghiệm do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

AMENDMENTS TO SOME ARTICLES ON DELEGATION OF 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 dated April 06, 2016; Law on amendments to certain Articles of the Law on Pharmacy dated November 21, 2024;

Pursuant to the Law on Government Organization dated February 18, 2025;

Pursuant to the Law on Local Government Organization dated June 16, 2025;

Pursuant to the Resolution No. 190/2025/QH15 dated February 19, 2025 of the National Assembly prescribing the handling of certain issues related to the arrangement of the state apparatus;

Pursuant to the Government’s Decree No. 150/2025/ND-CP dated June 12, 2025 on organization of specialized authorities affiliated to People’s Committees of provinces and central-affiliated cities and People’s Committees of communes, wards and special zones of provinces and central-affiliated cities;

Pursuant to the Government’s Decree No. 42/2025/ND-CP dated February 27, 2025 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

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

Article 1. Amendments to some Articles on delegation of the Circular No. 04/2018/TT-BYT dated February 09, 2018 of the Minister of Health on Good Laboratory Practice (hereinafter referred to as “the Circular No. 04/2018/TT-BYT”)

1. Clause 4 of Article 11 is amended as follows:

“4. The test facility that makes one of the changes specified in points d, dd and e clause 1 of this Article shall submit a change report enclosed with relevant technical documents to the Department of Health of the province where the laboratory is located. The Department of Health shall assess the change report sent by the test facility.

a) Within 07 working days from the date on which the change report is received, the Department of Health shall send a written consent to the change in case the change complies with GLP principles.

Within 03 working days from the date on which the written consent to the change is sent, the Department of Health shall publish the written consent to the change on its website;

b) Within 10 days from the date on which the change report is received, the Department of Health shall send a notification of necessary corrective actions in case the change fails to comply with GLP principles;

c) Within 45 days from the date on which the notification sent by the Department of Health is received, the test facility shall complete corrective actions and send a notification enclosed with evidences (documents, images, videos, certificates) proving that the deficiencies specified in the notification are corrected;

d) Within 10 days from the date on which the notification of corrective actions taken enclosed with evidences (documents, images, videos, certificates) are received, the Department of Health shall assess the correction result and conclude GLP compliance status of the test facility:

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- In case results of corrective actions show that the test facility still fails to comply with GLP principles, the Department of Health shall carry out an unscheduled inspection and process inspection result as prescribed in Article 12 of this Circular.”

2. Clause 2 of Article 18 is amended as follows:

“2. Departments of Health shall:

a) cooperate with relevant units in disseminating this Circular and provide guidelines for its implementation for units within their provinces;

b) join the inspectorate for inspection of compliance with GLP principles; carry out supervision and take actions against violations of regulations on compliance of test facilities within their provinces;

c) assess change reports of test facilities as prescribed in clause 4 Article 11 of this Circular;

d) publish written consents to changes on their website and send them to the Ministry of Health (the Drug Administration of Vietnam).”.

3. Form 04 - Certificate and Form 05 - Change report in the Appendix V to this Circular are amended.

Article 2. Effect

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Article 3. Transitional clauses

Any report on one of the changes specified in points d, dd and e clause 1 Article 11 of the Circular No. 04/2018/TT-BYT which is submitted to the Ministry of Health (the Drug Administration of Vietnam) before the effective date of this Circular shall continue to be processed in accordance with regulations in force at the time of submission.

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

PP. THE MINISTER
THE DEPUTY MINISTER




Do Xuan Tuyen

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