Circular No. 04/2018/TT-BYT on Good Laboratory Practices

CIRCULAR

Regulations on Good Laboratory Practice

 

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 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 the Circular regulations on Good Laboratory Practice.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the publication of application and assessment of compliance with Good Laboratory Practice.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Good Laboratory Practice is a set of principles and standards related to quality management systems concerning the organization and conditions for conducting non-clinical research in activities related to human health and environmental safety, planned, implemented, monitored, recorded, stored, and reported.

2. Deviation is a departure from Good Laboratory Practice principles and standards or other pharmaceutical laws.

3. testing facility refers to an entity engaged in drug analysis and testing activities within the territory of Vietnam, including public service units with testing functions, business entities providing drug testing services, and business entities providing biological equivalence testing services for drugs.

4. GLP is the abbreviation for the English term "Good Laboratory Practices," translated into Vietnamese as "Good Laboratory Practice."

5. WHO is the abbreviation for the English term "World Health Organisation," translated into Vietnamese as "World Health Organization."

6. OECD is the abbreviation for the English term "Organisation for Economic Co-operation and Development," translated into Vietnamese as "Organization for Economic Cooperation and Development."

Chapter II

ANNOUNCEMENT OF APPLICATION OF GOOD LABORATORY PRACTICE

Article 3. Principles and Standards of Good Laboratory Practice

1. Announce the application of the following principles and standards of Good Laboratory Practice:

a) The principles and standards of Good Laboratory Practice of the World Health Organization attached as Appendix I to this Circular and updated documents as stipulated in Clause 2 of this Article;

b) The principles and standards of Good Laboratory Practice of the Organization for Economic Cooperation and Development attached as Appendix II to this Circular and updated documents as stipulated in Clause 2 of this Article.

2. In case the GLP principles and standards specified in Clause 1 of this Article are amended or supplemented by WHO or OECD, the Department of Drug Management shall organize the translation and announcement of the amended or supplemented content on the Ministry of Health's Electronic Information Portal and the Department of Drug Management's Electronic Information Portal for relevant parties to search, update, and apply.

Article 4. Entities Subject to Application of Principles and Standards of Good Laboratory Practice

1. Drug testing entities and raw material testing entities voluntarily choose to implement and comply with GLP as specified in either Appendix I or II attached to this Circular and updated documents.

2. Vaccine testing entities, medical product testing entities, blood-derived product testing entities, and business entities providing biological equivalence testing services for drugs implement and comply with GLP as specified in Appendix II attached to this Circular and updated documents.

3. Testing entities apply updated GLP documents as stipulated in Clause 2 of Article 3 of this Circular within 12 months if there is a requirement for changes in analytical equipment or infrastructure, and within six months for other updates, calculated from the date of publication of the updated documents on the Ministry of Health's Electronic Information Portal and the Department of Drug Management's Electronic Information Portal.

Chapter III

ASSESSMENT OF COMPLIANCE WITH GOOD LABORATORY PRACTICE

Article 5. Documents serving as the basis for evaluating compliance with Good Laboratory Practice (GLP)

For technical documents on the testing facility presented according to the overall dossier guidelines specified in Appendix III attached hereto or the updated overall dossier in case of expansion of scope of activities.

2. The documents serving as the basis for evaluating GLP compliance for non-commercial testing facilities include:

a) Application form for GLP compliance assessment in accordance with Model No. 01 prescribed in Appendix V attached hereto;

b) Technical documents on the testing facility presented according to the overall dossier guidelines specified in Appendix III attached hereto.

3. In cases where the testing facility applies for both a GLP Certification and a Pharmaceutical Business Qualification Certificate, the testing facility must clearly state this in the Application Form for Pharmaceutical Business Qualification Certificate.

Article 6. Procedure for Evaluating Compliance with Good Laboratory Practice

1. Receiving documents:

The testing facility submits one set of documents in accordance with Article 5 of this Circular along with the review fee as prescribed by the Minister of Finance regarding the review fee for standards and conditions for drug testing to the Department of Drug Management - Ministry of Health.

In cases where the facility only engages in the business of biological equivalent drug testing services and applies for a Pharmaceutical Business Qualification Certificate, it must submit documents in accordance with the Minister of Health's regulations on Good Clinical Laboratory Practice.

a) Clauses 2, 3, 4, 5, and 6 of Article 50 of Decree No. 54/2017/ND-CP for testing facilities that engage in the sale of combined drugs containing addictive substances, combined drugs containing psychotropic substances, and combined drugs containing precursor substances;

b) Clauses 2, 3, 4, and 5 of Article 51 of Decree No. 54/2017/ND-CP for testing facilities that engage in the sale of toxic drugs, raw materials for toxic drugs; drugs, drug substances listed in the prohibited drug substance list for certain industries and fields;

c) Clauses 2, 4, and 5 of Article 33 of Decree No. 54/2017/ND-CP for pharmaceutical business establishments not covered by the cases specified in points a and b above;

d) Provisions on Good Clinical Laboratory Practice for testing facilities engaged in biological equivalent drug testing services.

3. Within five days from the date of receipt of valid documents, the Department of Drug Management will establish an Evaluation Team, notify the testing facility about the Evaluation Team and the anticipated time for on-site evaluation at the testing facility.

Within fifteen days from the date of receipt of the notification letter, the Evaluation Team will conduct on-site evaluation at the testing facility.

Article 7. Evaluation Process for Compliance and Classification of Compliance with Good Laboratory Practice (GLP)

1. Evaluation Process:

a) Step 1. The evaluation team announces the Decision on the establishment of the evaluation team, its purpose, content, and planned schedule for the evaluation at the testing facility.

b) Step 2. The testing facility presents a summary of its organizational structure, personnel, and implementation and application of GLP or other specific contents of the evaluation period.

c) Step 3. The evaluation team conducts an actual review of the implementation and application of GLP at the testing facility according to each specific content. During the evaluation process, the testing facility must carry out practical testing activities.

d) Step 4. The evaluation team meets with the testing facility to inform about any issues discovered during the evaluation (if any); assess the severity of each issue; discuss with the testing facility if there is disagreement between the testing facility and the evaluation team regarding the assessment of each issue; evaluate the degree of compliance with GLP principles and standards of the testing facility.

đ) Step 5. Draft and sign the evaluation minutes: The evaluation minutes are signed by the leader of the testing facility and the head of the evaluation team to confirm; the minutes must reflect the composition of the evaluation team, location, time, scope of the evaluation, and unresolved issues between the evaluation team and the testing facility related to the evaluation of GLP compliance (if any). The minutes are made in three copies: one copy retained at the testing facility, two copies retained at the Drug Administration Department.

e) Step 6. Complete the Evaluation Report: The evaluation team is responsible for preparing the GLP Evaluation Report according to Model No. 03 attached as Appendix V to this Circular, listing and analyzing the severity levels of issues that the testing facility needs to address and correct, comparing them with corresponding provisions of legal documents, assessing the degree of GLP compliance of the testing facility. Classify the severity levels of issues and assess the degree of GLP compliance of the testing facility according to the provisions in Appendix IV attached to this Circular. Send the GLP Evaluation Report to the testing facility as stipulated in point b, Clause 6, Article 33 of Decree No. 54/2017/NĐ-CP.

2. Assessment of Degree of GLP Compliance: The assessment of the degree of GLP compliance of the testing facility according to the provisions in Appendix IV attached to this Circular includes the following levels:

a) The testing facility complies with GLP at Level 1.

b) The testing facility complies with GLP at Level 2.

c) The testing facility complies with GLP at Level 3.

Article 8. Handling of Evaluation Results for Compliance with Good Laboratory Practice

1. In case the GLP Evaluation Report concludes that the testing facility complies with GLP at Level 1 as stipulated in point a, Clause 2, Article 7 of this Circular:

Within ten days from the date of completion of the actual evaluation at the testing facility and signing the evaluation minutes, the Drug Administration Department shall submit to the Minister of Health for issuance of a Certificate of Eligibility for Pharmaceutical Business or issue a GLP Certificate according to Model No. 04 prescribed in Appendix V attached to this Circular.

In case the testing facility conducts testing and pharmaceutical business subject to special control, within twenty days from the date of completion of the actual evaluation at the testing facility and signing the evaluation minutes, the Drug Administration Department shall submit to the Minister of Health for issuance of a Certificate of Eligibility for Pharmaceutical Business or issue a GLP Certificate according to Model No. 04 prescribed in Appendix V attached to this Circular.

2. In case the GLP Evaluation Report concludes that the testing facility complies with GLP at Level 2 as stipulated in point b, Clause 2, Article 7 of this Circular:

a) Within five days from the date of completion of the actual evaluation at the testing facility and signing the evaluation minutes, the Drug Administration Department sends a letter requesting the testing facility to take corrective actions for issues recorded in the Evaluation Report. In case the testing facility conducts testing and pharmaceutical business subject to special control, within fifteen days from the date of completion of the actual evaluation at the testing facility and signing the evaluation minutes, the Drug Administration Department sends a letter requesting the testing facility to take corrective actions for issues recorded in the Evaluation Report;

b) After completing the corrective actions, the testing facility must submit a report accompanied by evidence (document files, images, videos, certificates) proving the completion of the corrective actions for issues recorded in the Evaluation Report;

c) Within twenty days from the date of receipt of the corrective action report, the Drug Administration Department evaluates the results of the corrective actions taken by the testing facility and concludes on the status of GLP compliance of the testing facility: If the corrective actions meet the requirements, the Drug Administration Department shall submit to the Minister of Health for issuance of a Certificate of Eligibility for Pharmaceutical Business or issue a GLP Certificate according to Model No. 04 prescribed in Appendix V attached to this Circular; If the corrective actions do not meet the requirements, the Drug Administration Department shall send a reply explaining the reasons for non-issuance.

d) Within six months from the date the Drug Administration Department issues a request for modification and supplementation, the testing facility must submit modified and supplemented documents as required. After this period, if the testing facility does not modify and supplement or if the supplementary documents submitted twelve months after the initial submission do not meet the requirements, the submitted documents will lose their validity.

3. In case the GLP Evaluation Report concludes that the testing facility complies with GLP at Level 3 as stipulated in point c, Clause 2, Article 7 of this Circular: Within five days from the date of completion of the actual evaluation at the testing facility and signing the evaluation minutes, the Drug Administration Department issues a notification of non-compliance with GLP along with the GLP Evaluation Report to the testing facility and does not issue a certificate.

4. The Drug Administration Department issues a GLP Certificate according to Model No. 04 prescribed in Appendix V attached to this Circular to the testing facility for non-commercial purposes or upon request of a pharmaceutical business.

5. Within five days from the date of issuance of the Certificate of Eligibility for Pharmaceutical Business or GLP Certificate, the Drug Administration Department shall publish on the Ministry of Health's Electronic Information Portal and the Drug Administration Department's Electronic Information Portal the following information:

a) Name and address of the testing facility;

b) Name of the person responsible for pharmaceutical expertise and their Pharmaceutical Practitioner License number;

c) The number of the Business Registration Certificate meeting the business conditions and the number of the Good Laboratory Practice (GLP) Certification (if any);

d) The expiration date of the GLP compliance assessment;

đ) The scope of operation of the testing facility.

Chapter IV

ASSESSMENT OF THE MAINTENANCE OF GOOD LABORATORY PRACTICE COMPLIANCE

1. The periodic assessment period for maintaining GLP compliance at testing facilities (including non-commercial testing facilities) is three years, starting from the end date of the previous assessment (excluding any unscheduled assessments, inspections, or audits conducted by the Ministry of Health or the Department of Health).

In cases where a facility only engages in biological equivalent drug testing services, the periodic assessment shall be carried out in accordance with the regulations set forth by the Minister of Health regarding Good Clinical Laboratory Practices.

2. By November each year, the Drug Administration will publish on its official website the plan for the periodic assessment of GLP compliance maintenance for testing facilities in the following year.

3. Based on the periodic assessment plan published by the Drug Administration, testing facilities must submit the application for periodic assessment according to Clause 7 of this Article to the Drug Administration at least thirty days before the scheduled assessment date announced by the Drug Administration.

For example, if the planned periodic assessment date at Testing Facility A is August 18, 2018, then Testing Facility A must submit the application for assessment to the Drug Administration by July 18, 2018.

6. After submitting the application for the periodic assessment of GLP compliance maintenance within the prescribed timeframe, the testing facility may continue to operate within the scope specified in the Business Registration Certificate for pharmaceutical business or the GLP Certification for non-commercial testing facilities, from the date of submission until the results of the periodic assessment are available.

7. The application for the periodic assessment of GLP compliance maintenance includes:

a) An application form for the periodic assessment of GLP compliance maintenance according to Form No. 02 stipulated in Appendix V attached to this Circular;

b) Updated technical documentation concerning the physical infrastructure, technical equipment, and personnel of the testing facility (if there have been changes);

c) A summary report on the testing activities of the testing facility over the most recent three-year period from the date of the last assessment (excluding any unscheduled assessments, inspections, or audits conducted by the Ministry of Health or the Department of Health) up to the date of the application for periodic assessment.

8. The procedures for conducting the assessment, the assessment process, and the classification of the assessment results for GLP compliance are carried out in accordance with Articles 6 and 7 of this Circular.

Article 10. Handling the Results of Periodic Assessment of Compliance with Good Laboratory Practice (GLP)

1. In case the GLP Evaluation Report concludes that the testing facility complies with GLP at Level 1 as stipulated in point a, Clause 2, Article 7 of this Circular:

Within ten days from the date of completion of the on-site assessment at the testing facility and signing of the assessment record, the Drug Administration shall issue the GLP Certificate according to Model No. 04 stipulated in Appendix V attached to this Circular.

2. In case the GLP Evaluation Report concludes that the testing facility complies with GLP at Level 2 as stipulated in point b, Clause 2, Article 7 of this Circular:

a) Within five days from the date of completion of the on-site assessment at the testing facility and signing of the assessment record, the Drug Administration shall issue a written request for the testing facility to rectify and correct deficiencies, submit a report on rectification to the Drug Administration;

b) Within forty-five days from the date the Drug Administration issues the written request, the testing facility must complete the rectification and correction and submit a report accompanied by evidence (documentary files, images, videos, certificates) proving that the deficiencies noted in the assessment report have been rectified and corrected;

c) Within twenty days from the date of receipt of the report on rectification and correction accompanied by evidence (documentary files, images, videos, certificates), the Drug Administration shall evaluate the results of the rectification by the testing facility and conclude on the compliance status of the testing facility as follows:

- In case the rectification by the testing facility meets the requirements: The Drug Administration shall issue the GLP Certificate according to Model No. 04 stipulated in Appendix V attached to this Circular;

- In case the rectification by the testing facility does not meet the requirements: The Drug Administration shall issue a written request for further rectification and correction and submission of supplementary reports. The extended period for continued rectification and correction and reporting is forty-five days from the date of issuance of the request.

d) Within ninety days from the date of completion of the on-site assessment if the testing facility has no report on rectification or after rectification as provided for in point c clause 3 of this Article, if the rectification results still do not meet the requirements, the Drug Administration shall issue a notification of non-compliance with GLP and implement one or more measures as prescribed in points a and b of clause 3 of Article 3 of this Decree depending on the nature and severity of the violation.

3. In case the GLP assessment report concludes that the testing facility complies with GLP at level 3 as prescribed in point c clause 2 of Article 7 of this Circular:

Within five days from the date of completion of the assessment at the testing facility and signing of the assessment record, based on the evaluation of the risks of deficiencies discovered regarding drug quality and user safety, the Drug Administration shall issue a notification of non-compliance with GLP and implement one or more of the following measures:

a) Administrative penalties according to laws on administrative violations.

b) Submit to the Minister of Health for a decision to revoke the Business Registration Certificate issued and carry out the revocation of the GLP Certificate (if any) in accordance with Article 40 of the Medicine Law.

In case the testing facility does not comply with one or several business scopes in the Business Registration Certificate issued, the Drug Administration shall submit to the Minister of Health for a decision to revoke the Business Registration Certificate issued to remove the non-compliant business scope and carry out the revocation of the GLP Certificate (if any) in accordance with Article 40 of the Medicine Law and issue a new Business Registration Certificate appropriate to the business scope that the testing facility complies with.

4. Within five days from the date of conclusion that the testing facility maintains compliance with GLP or from the date of issuance of the Decision to revoke the Business Registration Certificate issued due to non-compliance with GLP, the Drug Administration shall update on the Drug Administration's Electronic Information Website about the compliance status with GLP in accordance with the provisions of clause 5 of Article 8 of this Circular for the testing facility that complies with GLP or information about the revocation of the Business Registration Certificate, GLP Certificate (if any) issued for the testing facility that does not maintain compliance with GLP.

Article 11. Change Control

1. During the period between periodic assessments, the testing facility must apply for issuance of the Business Registration Certificate in accordance with point b clause 1 of Article 36 of the Medicine Law or submit a change report according to Model No. 05 stipulated in Appendix V attached to this Circular if it falls under any of the following cases:

a) Change as prescribed in point b clause 1 of Article 36 of the Medicine Law;

b) Change of laboratory location within the same business premises;

c) Addition of a new laboratory at a different location within the same business premises;

d) Expansion of the laboratory based on the existing laboratory structure;

đ) Major repair or change in the structure and layout within the laboratory;

e) Change in auxiliary systems or change in the design principle and operation of utility systems affecting the laboratory environment.

2. In case the testing facility changes as prescribed in point a clause 1 of this Article, the testing facility must submit an application for issuance of the Business Registration Certificate in accordance with clauses 2 and 4 of Article 38 of the Medicine Law or a dossier in accordance with clause 2 of Article 5 of this Circular for non-commercial testing facilities.

The procedures for assessing compliance with GLP, classifying results, and handling the results of the degree of compliance with GLP are carried out in accordance with Articles 6, 7, and 8 of this Circular.

3. In case the testing facility changes as prescribed in points b and c clause 1 of this Article, the testing facility must submit a change report along with corresponding technical documentation to the Drug Administration.

a) The Drug Administration shall conduct an on-site assessment at the testing facility. If the testing facility meets the requirements, the Drug Administration shall issue a written approval of the change made by the testing facility;

b) The procedures for assessing, classifying results, and handling the results of the assessment for the testing facility that changes as prescribed in point b clause 1 of this Article are carried out in accordance with Articles 6, 7, and 10 of this Circular;

c) The procedure for evaluating, classifying results, and handling evaluation results for testing facilities that change according to the provisions of point c, Clause 1 of this Article shall be carried out in accordance with Articles 6, 7, and 8 of this Circular.

a) Within ten days from the date of receipt of the notification document, the Drug Administration Department shall issue a notification document agreeing with the content of the change if the change meets the requirements.

b) Within ten days from the date of receipt of the notification document, the Drug Administration Department 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 Drug Administration Department issues the notification document, the testing facility must complete the corrections and improvements and submit a notification document accompanied by evidence (documentation files, images, videos, certificates) proving the completion of the corrections and improvements mentioned in the notification document.

d) Within ten days from the date of receipt of the correction report accompanied by evidence (documentation files, images, videos, certificates), the Drug Administration Department shall evaluate the testing facility's correction results and conclude on the compliance status of the Good Laboratory Practice (GLP) of the testing facility:

- If the corrections have met the requirements: The Drug Administration Department shall issue a notification document agreeing with the content of the change.

- If the corrections have not met the requirements: The Drug Administration Department shall conduct an urgent assessment and handle the evaluation results in accordance with Article 12 of this Circular.

Article 12. Urgent Assessment, Inspection, and Supervision of Compliance with Good Laboratory Practices

1. The inspection and supervision work for maintaining compliance with GLP at testing facilities shall be conducted in accordance with the provisions of the law.

a) The testing facility has not met the requirements for corrections as stipulated in point d, Clause 4, Article 11 of this Circular;

b) A testing facility operating under Level 2 GLP compliance, as specified in point b, Clause 2, Article 7 of this Circular, must undergo an urgent assessment at least once within three years from the end of the previous assessment period;

c) The testing facility has been found to have serious violations of GLP principles and standards based on the inspection and supervision results of competent authorities;

d) In cases where there are reports or recommendations indicating serious violations of GLP principles and standards.

3. The composition of the Evaluation Team shall be determined by the Director of the Drug Administration Department based on the scope and purpose of the assessment.

4. The procedures for conducting the urgent assessment and handling the assessment results at testing facilities shall be carried out in accordance with Articles 7 and 10 of this Circular.

Chapter V

INSPECTION TEAM FOR COMPLIANCE WITH GOOD LABORATORY PRACTICES

BEST PRACTICES FOR TESTING AND RESEARCH LABORATORIES

Article 13. Composition and Standards for Members of the Evaluation Team

1. The composition of the Evaluation Team includes:

a) The Team Leader and Secretary belong to the Drug Administration Department;

b) At most two members representing the Central Institute for Pharmaceutical Testing or the Ho Chi Minh City Institute for Pharmaceutical Testing or the National Institute for Vaccine and Biomedical Product Control (for vaccine and pharmaceutical product testing facilities);

c) One member representing the Health Department of the province or centrally administered city (hereinafter referred to as the Health Department) where the testing facility's laboratory is located.

2. Staff participating in the Evaluation Team must meet the following standards:

a) Having a bachelor's degree or higher, trained in medical, pharmaceutical, biological, or chemical sciences with experience in analytical testing, quality control of medicines, and pharmaceutical management activities;

b) Having received training and instruction on GLP, inspections, and evaluations of GLP, and being well-versed in GLP principles and standards;

c) Being honest, impartial, and strictly adhering to regulations and laws during the evaluation process without conflicts of interest with the evaluated testing facility as stipulated in Clause 3 of this Article;

d) The Team Leader must have a bachelor's degree in pharmacy or a related biological or chemical field, with at least two years of experience in pharmaceutical management.

3. Conflict of Interest Evaluation Principle: An Evaluation Team member shall be considered to have a conflict of interest with the evaluated testing facility if they fall into any of the following situations:

a) They have worked for the evaluated testing facility in the last five years;

b) They have provided consultancy services for the evaluated testing facility in the last five years;

c) They currently have financial interests with the evaluated testing facility;

d) Their spouse, children, parents, siblings, parents-in-law, or spouses' parents are employed by the evaluated testing facility.

Article 14. Responsibilities and Authorities of the Evaluation Team

1. Responsibilities of the Inspection Team:

a) Evaluate all activities of the testing facility according to the principles and standards GLP as stipulated in Article 3 of this Circular, the updated versions of the GLP principles and standards, and current relevant professional regulations; specifically record the contents of the evaluation, identified issues, draft the evaluation report and the GLP Evaluation Report;

b) Report the evaluation results or provide explanations regarding the GLP Evaluation Report when the testing facility has differing opinions on the contents of the GLP Evaluation Report;

c) Maintain confidentiality over all information related to the evaluation period and all information related to the testing facility's testing activities, except with the consent of the testing facility or upon request from competent state authorities for inspection, supervision, and investigation purposes;

2. Authorities of the Inspection Team:

a) Inspect all areas and laboratories within the testing facility and have the authority to request inspections of other related areas concerning the testing facility's testing activities;

b) Require the provision of documents and records related to the business operations, quality management, and testing activities of the testing facility;

c) Conduct the collection of documentary evidence (photocopies of documents, photographs, videos) regarding issues discovered during the evaluation process;

d) Take samples of drugs and drug ingredients for quality control checks as prescribed by law;

đ) Draft minutes, require the testing facility to temporarily suspend one or more parts or all testing activities related to violations if, during the evaluation process, the Evaluation Team discovers serious violations affecting the accuracy of analytical results; report to the authorized person to issue formal decisions on handling;

Chapter VI

IMPLEMENTING PROVISIONS

Article 15. Effective Date

1. This Circular takes effect from March 26, 2018.

2. The following documents shall cease to be effective from the date this Circular takes effect:

a) Decision No. 1570/2000/QĐ-BYT dated May 22, 2000, issued by the Minister of Health on the implementation of the Good Laboratory Practice (GLP) principle;

b) The provisions on Good Laboratory Practice (GLP) in Circular No. 45/2011/TT-BYT dated December 21, 2011, issued by the Minister of Health amending and supplementing certain articles of Decision No. 1570/2000/QĐ-BYT dated May 22, 2000, issued by the Minister of Health on the implementation of the GLP principle; Decision No. 2701/2001/QĐ-BYT dated June 29, 2001, issued by the Minister of Health on the implementation of the GLP principle; Circular No. 06/2004/TT-BYT dated May 28, 2004, issued by the Minister of Health guiding the production and processing of drugs; Decision No. 3886/2004/QĐ-BYT dated November 3, 2004, issued by the Minister of Health on the implementation of the GLP principle and standards according to the World Health Organization's recommendations; Circular No. 13/2009/TT-BYT dated September 1, 2009, issued by the Minister of Health guiding advertising activities for drugs; Circular No. 22/2009/TT-BYT dated November 24, 2009, issued by the Minister of Health on drug registration; Circular No. 47/2010/TT-BYT dated December 29, 2010, issued by the Minister of Health guiding the export and import of drugs and direct contact packaging materials;

Article 16. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 17. Transitional Provisions

1. For testing facilities that have been granted a Business Registration Certificate for pharmaceutical business scope including testing services for drugs, drug ingredients, and/or biological equivalent testing services for drugs, or a GLP Certificate with validity periods still in effect, issued before the date this Circular takes effect, such testing facilities are permitted to continue their testing activities until the expiration date stated on the certificate.

In case the Business Registration Certificate expires, the testing facility must proceed with the procedures to apply for a new Business Registration Certificate in accordance with Chapter III of this Circular.

In case the GLP Certificate expires earlier, the testing facility must proceed with the procedures to apply for a GLP compliance assessment in accordance with Chapter IV of this Circular to continue its activities until the expiration date stated on the Business Registration Certificate.

2. For testing facilities that have been granted a Business Registration Certificate for unlimited testing service business scope, when the GLP Certificate expires, the testing facility must proceed with the procedures to apply for a GLP compliance assessment in accordance with Chapter IV of this Circular.

3. For applications for a Business Registration Certificate or periodic GLP compliance assessment applications submitted to the Drug Administration Department before the date this Circular takes effect, the Drug Administration Department will continue to evaluate the testing facilities based on the GLP standards issued together with Decision No. 1570/2000/QĐ-BYT dated May 22, 2000, issued by the Minister of Health on the implementation of the GLP principle or this Circular if the testing facility requests it.

Article 18. Responsibility for Implementation

1. The Drug Administration Department shall be responsible for:

a) Lead and coordinate with relevant units to organize the dissemination of the contents of this Circular;

b) Serve as the focal point and coordinate with relevant units to guide and implement the Circular for provincial health departments, sectoral health departments, and testing facilities within their functional and assigned tasks;

c) Compile and publish on the Drug Administration Department’s website a list of national testing facilities that have been granted a Business Registration Certificate and a GLP Certificate, update the status of the Business Registration Certificate and GLP Certificate, compliance status, and other information as stipulated in Clause 5, Article 8 of this Circular, within their functional and assigned tasks;

d) Publish updated GLP documents on the Ministry of Health’s e-Government Portal and the Drug Administration Department’s website;

đ) Serve as the focal point or coordinate with the Ministry’s Inspectorate to conduct inspections and audits on GLP compliance and handle violations within their authority;

a) Coordinating with relevant units to organize the dissemination of this Circular and provide guidance on implementation to units within its jurisdiction;

b) Participate in the Inspection Team for GLP compliance assessments; supervise and handle violations within their authority regarding GLP compliance for testing facilities in their jurisdiction;

3. Testing facilities are responsible for:

a) Implementing this Circular in accordance with the actual conditions of the testing facility;

b) Ensure compliance with GLP principles and standards throughout the operation of the testing facility;

c) Conduct testing activities within the scope permitted, in accordance with legal regulations. In case of difficulties or obstacles during implementation, it is recommended to report to the Ministry of Health (Medicine Administration Department) for consideration and resolution;

In case of difficulties or obstacles during implementation, it is recommended to report to the Ministry of Health (Medicine Administration Department) for consideration and resolution./.