Circular No. 29/2012/TT-BYT on procedures for issuing and reissuing certificates of biosafety standards for laboratories

CIRCULAR

Regulations on issuing new and reissuing certificates for laboratories meeting biosafety standardsRegulations on issuing new and reissuing certificates for laboratories meeting biosafety standards

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Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Clause 5, Article 12 of Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government detailing the implementation of the Law on Prevention and Control of Infectious Diseases regarding ensuring biosafety in laboratories;

Considering the proposals of the Director of the Preventive Medicine Department and the Head of the Legal Department;

The Ministry of Health hereby stipulates the procedures for issuing new and reissuing certificates for laboratories meeting biosafety standards as follows:

Article 1. Scope of Regulation and Applicability

Article 1. This Circular stipulates the dossier, procedures, and process for issuing new and reissuing certificates for laboratories meeting biosafety standards (hereinafter referred to as biosafety certificates).

Article 2. This Circular does not apply to the issuance of new and reissuing biosafety certificates for laboratories under the management authority of the Ministry of Public Security and the Ministry of National Defense.

Article 2. Dossier for applying for a new biosafety certificate

1. Dossier for applying for a new biosafety certificate level I:

a) Application form for a new biosafety certificate according to the model prescribed in Appendix 1 attached hereto;

b) Staff roster according to the model prescribed in Appendix 2 attached hereto, accompanied by individual dossiers of each staff member working in the laboratory, including:

- Certified copy of the decision on recruitment or labor contract;

- Certified copy of the relevant professional qualification certificate;

- Certified copy of the confirmation of having attended training on biosafety at healthcare facilities designated by the Minister of Health or certified copy of the confirmation of having attended training abroad on biosafety issued by competent authorities overseas.

c) Equipment roster according to the model prescribed in Appendix 3 attached hereto;

d) Floor plan of the laboratory, including: design drawings of the testing area; design drawings of windows and doors; design drawings of the electrical system; design drawings of the water supply and drainage system; layout of fire prevention and extinguishing equipment;

đ) Documents proving the establishment and operation of the facility with the laboratory applying for the biosafety certificate:

- Certified copy of the establishment decision for state-owned healthcare facilities or certified copy of the business registration certificate for private healthcare facilities or investment certificate for healthcare facilities with foreign capital;

- Certified copy of the operating permit of the facility (applicable only to medical examination and treatment facilities).

2. Dossier for applying for a new biosafety certificate level II:

In addition to the documents prescribed in Clause 1 of this Article, the facility applying for a biosafety certificate level II must submit the following additional documents:

a) Diagram of wastewater treatment system and test results showing compliance with national technical standards for the environment;

b) Description of material specifications for each type of door and window;

c) Description of material specifications for each type of equipment used in the electrical and water systems;

d) Maintenance and repair report for testing equipment.

3. Dossier for applying for a new biosafety certificate level III and level IV:

In addition to the documents prescribed in Clauses 1 and 2 of this Article, the facility applying for a biosafety certificate level III and level IV must submit the following additional documents:

a) Design of chemical waste liquid treatment system and test results showing compliance with national technical standards for the environment;

b) Design accompanied by description of material specifications for each type of equipment used in the ventilation system.

Article 3. Documents for Application to Reissue a Biosafety Certificate

1. In case the biosafety certificate has expired:

a) An application form for reissuing a biosafety certificate according to the model prescribed in Appendix 4 attached hereto;

b) The expired biosafety certificate;

c) A report on personnel changes (if any), accompanied by the documents specified in Point b Clause 1 Article 2 of this Circular;

d) A report on equipment changes: clearly stating the name of the equipment, quantity, and status of new equipment added or replaced as prescribed in Appendix 3 attached hereto;

đ) A report on facility changes, accompanied by a description of the specifications of materials used for each type of replaced equipment;

e) A report on any biosafety incidents that have occurred (if any). The report must specify the time of occurrence, the severity of the incident, and the measures taken to address and resolve the biosafety incident.

2. In case the biosafety certificate is damaged or lost: An application form for reissuing a biosafety certificate according to the model prescribed in Appendix 4 attached hereto.

3. In case of application for reissuing a biosafety certificate due to a change in the name of the testing facility, the application package shall include:

a) An application form for reissuing a biosafety certificate according to the model prescribed in Appendix 5 attached hereto;

b) The biosafety standard certification already issued;

c) Documents proving the change in the name of the testing facility: certified copies of the establishment decision for state-owned healthcare facilities or certified copies of the business registration certificate for private healthcare facilities or investment certificates for healthcare facilities with foreign capital.

Article 4. Acceptance of Applications for Issuance and Reissuance of Biosafety Certificates

1. Authorities accepting applications for issuance of biosafety certificates:

a) The Health Department's Medical Services Division of the provincial or centrally-administered city health department (hereinafter referred to as "province") where the testing facility is located, accepts applications for issuance and reissuance of Level I and Level II biosafety certificates;

b) The Preventive Medicine Department of the Ministry of Health accepts applications for issuance and reissuance of Level III and Level IV biosafety certificates.

2. Time limit for submission of applications:

a) For facilities established and operating before the effective date of this Circular: biosafety certificates shall be reviewed and issued before January 1, 2015;

b) For facilities established and operating after the effective date of this Circular, they may only conduct testing activities after obtaining a biosafety certificate;

c) For applications to reissue an expired biosafety standard certification, the testing facility must submit the application package to the competent authority specified in Clause 1 of this Article at least 60 (sixty) days prior to the expiration of the testing facility's biosafety standard certification. If the application is not submitted within the above period, the facility must follow the procedure for issuing a new biosafety certificate.

3. Upon receipt of the application, the receiving authority shall issue a receipt for the application package to the applicant according to the model prescribed in Appendix 6 attached hereto.

Article 5. Procedure for considering applications for new issuance and reissuance of biosafety certificates

1. Within 10 (ten) working days from the date of receiving the application file, the agency receiving the file must conduct a review of the file.

2. In case the file is complete and valid, the agency receiving the file must:

a) Organize the review at the laboratory within 30 (thirty) working days from the date of receiving the file;

b) Reissue the biosafety certificate within 10 (ten) working days from the date of receiving the file. In case the certificate is not reissued, there must be a written response stating the reasons.

3. In case the file is incomplete or invalid, within 10 (ten) working days from the date of receiving the file, the agency receiving the file must notify in writing to the entity applying for the certificate to complete the file. The notification must specify in detail the supplements and contents that need to be amended.

4. Upon receipt of the document requesting to complete the file, the entity applying for the new issuance or reissuance of the biosafety certificate must supplement and amend according to the contents recorded in the notification document of the agency receiving the file. The date of receiving the supplemented and amended file is recorded on the receipt form. After 10 (ten) working days from the date of receiving the supplemented and amended file, if the agency receiving the file does not issue a document requesting amendments or supplements, it must complete the review of the file.

5. In case the entity applying for the biosafety certificate has supplemented and amended the file but not in accordance with the requirements, the agency receiving the file will notify the entity applying for the certificate to continue completing the file in accordance with Clause 3 of this Article.

Article 6. Organization of the review team for new issuance and reissuance of biosafety certificates

1. The Director of the Provincial Health Department decides on the establishment of the review team for the new issuance and reissuance of biosafety certificates for Level I and Level II laboratories under their management, consisting of the following members:

a) A representative of the Provincial Health Department's leadership serving as the Head of the Team;

b) A representative of the Provincial Center for Preventive Medicine's leadership serving as the Deputy Head of the Team;

c) A representative of the Provincial Health Department's Medical Affairs Office;

d) A representative of one of the Central Institute of Hygiene and Epidemiology, Nha Trang Pasteur Institute, Ho Chi Minh City Pasteur Institute, or West Central Hygiene and Epidemiology Institute, based on the regional management division issued by the Minister of Health;

đ) A representative of the Provincial Health Department's Inspectorate;

e) Experts and relevant staff invited upon the request of the Head of the Team;

g) A specialist from the Provincial Health Department's Medical Affairs Office serving as the Secretary of the Review Team.

2. The Minister of Health decides on the establishment of the review team for the new issuance and reissuance of biosafety certificates for Level III and Level IV laboratories, consisting of the following members:

a) A representative of the leadership of the National Center for Preventive Medicine serving as the Head of the Team;

b) A representative of the leadership of the Central Institute of Hygiene and Epidemiology serving as the Deputy Head of the Team;

c) A representative of the Legal Affairs Department;

d) A representative of the Department of Medical Equipment and Health Facilities;

đ) A representative of one of the Central Institute of Hygiene and Epidemiology, Nha Trang Pasteur Institute, Ho Chi Minh City Pasteur Institute, or West Central Hygiene and Epidemiology Institute, based on the regional management division issued by the Minister of Health;

e) A representative of the Provincial Health Department where the laboratory applying for the biosafety certificate is located;

g) Experts and relevant staff invited upon the request of the Head of the Team;

h) A specialist from the National Center for Preventive Medicine serving as the Secretary of the Review Team.

3. The Standing Committee of the Review Team specified in Clause 1 of this Article is located at the Provincial Health Department's Medical Affairs Office. The Standing Committee of the Review Team specified in Clause 2 of this Article is located at the National Center for Preventive Medicine - Ministry of Health.

Article 7. Procedure for issuing new and reissuing biosafety certificates

1. Procedure for issuing new biosafety certificates:

a) Legal file review: checking material conditions, equipment, and organizational staffing of the laboratory applying for a biosafety certificate to ensure it meets safety standards;

b) On-site inspection at the laboratory and preparation of an inspection report for biosafety level I, II, III, and IV laboratories according to the models specified in Appendices 7, 8, 9, and 10 issued with this Circular;

c) The inspection report of the facility applying for a new biosafety certificate and the corrective action file (if any) shall be kept as follows:

- For laboratories under the jurisdiction of the Ministry of Health, three copies shall be made: one copy kept at the Ministry of Health, one copy kept at the Provincial Department of Health where the facility applying for a new biosafety certificate is located, and one copy kept at the facility applying for a new biosafety certificate that has been inspected;

- For laboratories under the jurisdiction of the Provincial Department of Health Director, two copies shall be made: one copy kept at the Provincial Department of Health and one copy kept at the facility applying for a new biosafety certificate that has been inspected.

2. Procedure for reissuing biosafety certificates includes:

a) Reviewing the previous inspection files for biosafety certificates already issued and stored at the Ministry of Health or Provincial Department of Health, or damaged operating licenses (if any), and other documents as stipulated in Article 3 of this Circular;

b) In cases requiring on-site inspection at the laboratory upon request of the inspection team, and reissue the biosafety certificate.

3. Management of biosafety certificates:

a) Each laboratory is only granted one biosafety certificate according to the model specified in Appendix 11 issued with this Circular;

b) Application files for issuing new and reissuing biosafety certificates shall be kept at the issuing authority;

c) After issuing a biosafety certificate to a facility:

- The Ministry of Health sends a notification letter to the People's Committee of the province and the Provincial Department of Health where the laboratory has been granted a biosafety certificate within thirty days from the date of issuance of the new or renewed biosafety certificate;

- The Provincial Department of Health sends a notification letter to the People's Committee of the district, city, town, or provincial city where the laboratory has been granted a biosafety certificate within thirty days from the date of issuance of the new or renewed biosafety certificate.

Article 8. Fees for Issuing New and Reissuing Biosafety Certificates

1. Facilities applying for a biosafety certificate are responsible for paying the fee for issuing the biosafety certificate at the time of submitting the application for the biosafety certificate;

2. Collection, management, and use of fees for issuing biosafety certificates shall be carried out in accordance with regulations of the Ministry of Finance.

Article 9. Effective Date

This Circular takes effect from February 1, 2013

Article 10. Responsibility for Implementation

1. The Director of the Preventive Medicine Department, the Director of the Medical Equipment and Construction Department, and the Director of the Legal Affairs Department, within their respective functions, duties, and authorities assigned, are responsible for coordinating with relevant Departments, Bureaus, and General Departments to organize inspections and audits of the issuance of new and reissued biosafety certificates and compliance with laws by facilities with biosafety laboratories nationwide.

2. The Director of the Provincial Department of Health is responsible for organizing inspections and audits of the issuance of new and reissued biosafety certificates and compliance with laws by facilities with biosafety laboratories within the local jurisdiction.

During implementation, if there are any difficulties, they should be promptly reported to the Ministry of Health (Preventive Medicine Department) for research and resolution.