Circular No. 36/2025/TT-BYT amends certain provisions on the分级制度in Circular No. 04/2018/TT-BYT concerning Good Laboratory Practice, focusing on changes to the management of change reports by testing facilities and the responsibility of Provincial Health Departments.
适用范围
Testing facilities, Provincial Health Departments of provinces/cities directly under the Central Government
要点
- Testing facilities must submit change reports to the Provincial Health Department within seven working days from the date of change (Article 1).
- The Provincial Health Department must notify approval or request for rectification and correction within ten days from the date of receipt of the change report (Article 1).
- Testing facilities must complete rectification and correction and submit evidence proving such actions within forty-five days from the date of receipt of the notification requesting rectification (Article 1).
- The Provincial Health Department evaluates the results of rectification and correction and decides to approve or transfer the file to the Drug Administration Bureau for handling (Article 1).
- The Provincial Health Department is responsible for disseminating this Circular, participating in inspection teams to assess compliance with GLP, and publishing information on the unit's website (Article 2).
🌐 本文件的社会影响
- Strengthening quality management of medical laboratories
- Reducing processing time for change applications, facilitating testing facilities
- Enhancing the responsibility of Provincial Health Departments in supervision and violation handling
❓ 常见问题
To which entity must testing facilities submit change reports?
Change reports along with related technical documents must be submitted to the Provincial Health Department where the laboratory is located.
What is the maximum time for the Provincial Health Department to notify approval or request for rectification?
The Provincial Health Department must notify within ten days from the date of receipt of the change report.
What happens if testing facilities fail to complete rectification and correction within the prescribed period?
The Provincial Health Department will send the evaluation results to the Drug Administration Bureau for handling according to Article 12 of this Circular.
Within what timeframe must testing facilities complete rectification and correction?
Within forty-five days from the date of receipt of the notification requesting rectification from the Provincial Health Department.
What responsibilities does the Provincial Health Department have regarding this Circular?
Cooperating in dissemination, participating in inspection teams to assess compliance with GLP, and publishing information on the unit's website.
全文
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
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Number: 36/2025/TT-BYT |
Hanoi, July 28, 2025 |
CIRCULAR
AMENDING AND SUPPLEMENTING CERTAIN PROVISIONS ON THE GRADATION OF CIRCULAR 04/2018/TT-BYT OF FEBRUARY 9, 2018, ISSUED BY THE MINISTER OF HEALTH REGARDING GOOD LABORATORY PRACTICE
Pursuant to Decree No. 163/2025/NĐ-CP dated June 29, 2025 of the Government detailing certain provisions and measures for organizing and guiding the implementation of the Medicine Law;
Pursuant to the Government Organization Law on February 18, 2025;
Pursuant to the Law on Local Administration Organization dated June 16, 2025;
Pursuant to Resolution No. 190/2025/QH15 dated February 19, 2025 of the National Assembly on handling certain issues related to the restructuring of state administrative bodies;
Pursuant to Decree No. 150/2025/NĐ-CP dated June 12, 2025 of the Government on the organization of specialized agencies under provincial people's committees and district-level city people's committees and municipal special zones under provincial and district-level city people's committees;
Pursuant to Decree No. 42/2025/NĐ-CP dated February 27, 2025 of the Government 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 hereby promulgates this Circular amending and supplementing certain provisions on the gradation of Circular No. 04/2018/TT-BYT dated February 9, 2018 of the Minister of Health regarding Good Laboratory Practice (hereinafter referred to as Circular No. 04/2018/TT-BYT).
Article 1. Amending and supplementing certain provisions of Circular No. 04/2018/TT-BYT dated February 9, 2018 of the Minister of Health regarding Good Laboratory Practice (hereinafter referred to as Circular No. 04/2018/TT-BYT)
1. Amending Clause 4 of Article 11 as follows:
"4. In cases where testing facilities undergo changes as stipulated in Points d, đ, and e of Clause 1 of this Article, the testing facility must submit a change report along with relevant technical documents to the Department of Health at the location of the laboratory. The Department of Health shall evaluate the change report of the testing facility.
a) Within seven working days from the date of receipt of the change report from the testing facility, the Department of Health shall issue a notification document agreeing to the content of the change if the change meets the requirements. Within three working days from the date of issuance of the notification document agreeing to the content of the change, the Department of Health shall publish the notification document agreeing to the content of the change on its electronic information website;
b) Within ten days from the date of receipt of the change report from the testing facility, the Department of Health shall issue a notification document specifying the necessary corrections and improvements if the change does not meet the requirements;
c) Within forty-five days from the date the Department of Health issues a notification document specifying the necessary corrections and improvements, the testing facility must complete the corrections and improvements and submit a notification document accompanied by evidence (files, images, videos, certificates) proving that the corrections and improvements have been completed as stated in the notification document of the Department of Health;
d) Within ten days from the date of receipt of the correction and improvement report from the testing facility accompanied by evidence (files, images, videos, certificates), the Department of Health shall assess the results of the corrections and improvements made by the testing facility and conclude on the compliance status of the testing facility with GLP:
- If the corrections have met the requirements: The Department of Health shall issue a notification document agreeing to the content of the change and publish the information on its electronic information website.
- If the corrections have not met the requirements: The Department of Health shall send the assessment report of the correction report along with the change report of the testing facility to the Drug Administration Department for urgent assessment and handle the assessment results according to the provisions of Article 12 of this Circular."
with
"2. The Department of Health shall be responsible for:
a) Coordinating with relevant units to organize the dissemination of this Circular and provide guidance on implementation to units within its jurisdiction;
b) Participating in inspection teams to evaluate compliance with GLP; supervising and handling violations within its authority for testing facilities within its jurisdiction;
c) Implementing the evaluation of change reports of testing facilities as prescribed in Clause 4 of Article 11 of this Circular;
d) Publishing on the electronic information website of the unit and sending to the Ministry of Health (Drug Administration Department) the notification document agreeing to the content of the change."
3. Amending Model 04 - Certificate, Model 05 - Change Report of Appendix V Forms accompanying this Circular.
Article 2. Effective Date
This Circular takes effect from September 11, 2025.
Article 3. Transitional Provisions
Change reports belonging to the cases stipulated in Point d, đ, and e of Clause 1 of Article 11 of Circular No. 04/2018/TT-BYT submitted to the Ministry of Health (Drug Administration Department) before the effective date of this Circular shall continue to be processed according to the regulations at the time of submission.
During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals should reflect them to the Ministry of Health (Drug Administration Department) for consideration and resolution./.
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DEPUTY MINISTER |
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