Thông tư 29/2012/TT-BYT

CIRCULAR

ON PROCEDURES FOR ISSUANCE/REISSUANCE OF CERTIFICATES OF BIOSAFETY TO LABORATORIES

Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 by the Government defining the functions, tasks, entitlements and organizational structure of the Ministry of Health;

Pursuant to Clause 5 Article 12 of the Decree No. 92/2010/ND-CP dated 30/8/2010 by the Government detailing the implementation of the Law on prevention and control of infectious diseases regarding biosafety in laboratories;

At the proposal of the Director of General Department of Preventive Medicine, Director of Legal Department;

The Ministry of Health promulgates regulations on procedures for issuance/reissuance of certificates of satisfaction of biosafety standards as follows:

Article 1. Governing scope and regulated entities

1. This Circular provides for required documents in application, procedures for issuance/reissuance of Certificates of Biosafety to laboratories.

2. This Circular does not apply to the issuance/reissuance of certificates of biosafety for laboratories under the management of the Ministry of Public Security and the Ministry of National Defense.

Article 2. Application for new Certificates of Biosafety

1. An application for a new Certificate of Biosafety Level I shall comprise:

a) An application form in Annex 1 enclosed with this Circular;

b) A list of specialized employees in the laboratory using the form in Annex 2 enclosed with this Circular and personal dossiers of each of them, including:

- A certified true copy of the recruitment decision or the labor contract;

- Certified true copies of qualifications suitable for the tests;

- A certified true copy of the certificate of completion of training in biosafety issued by a medical facility appointed by the Minister of Health or a certified true copy of the certificate of completion of overseas training in biosafety issued by a foreign competent authority.

c) A list of equipment using the form in Annex 3 enclosed with this Circular;

d) The site plan of the laboratory, including the design of the testing area; the design of the door and window system; the design of the electricity system; the design of the water supply and drainage system; the placement of fire safety equipment;

dd) Documents proving the establishment and operation of the medical facility whose laboratory applies for the Certificate of Biosafety:

- A certified true copy of the establishment decision (if the applicant is a state-owned medical facility) or a certified true copy of the Certificate of Business registration (if the applicant is a private medical facility) or the investment certificate (if the applicant is a foreign invested medical facility);

- A certified true copy of the operation license of the medical facility (if the applicant is a healthcare facility).

2. An application for a new Certificate of Biosafety Level II shall comprise:

Apart from documents specified in Clause 1 of this Article, the applicant for the Certificate of  Biosafety Level II must also submit the following documents:

a) The map of sewage treatment system and the results of testing result proving the wastewater satisfying National technical regulation on water environment;

b) The description of the specifications of the materials of each type of door and window;

c) The description of the specifications of the materials of every equipment used in the electricity system and water system;

d) A report on the maintenance of testing equipment.

3. An application for a new Certificate of Biosafety Level III and IV shall comprise:

Apart from documents specified in Clauses 1 and Clause 2 of this Article, the applicant for the Certificate of Biosafety Level III and IV must also submit the following documents:

a) A design of the treatment system for liquid waste by chemical and the testing results proving the satisfaction of national technical regulation on environment;

b) A design enclosed with the description of the specifications of the materials of every equipment used in the ventilation system.

Article 3. Applications for reissuance of Certificates of Biosafety

1. Regarding expired Certificates of Biosafety, an application shall comprise:

a) An application form in Annex 4 enclosed with this Circular;

b) The expired Certificate of Biosafety;

c) A report on changes to the staff (if any) enclosed with document specified in Point b Clause 1 Article 2 of this Circular;

d) A report on changes related to equipment which specifies their names, quantity and conditions of the supplementary or replaced equipment according to regulations in Annex 3 enclosed with this Circular;

dd) A report on changes related to facilities enclosed with the description of the specifications of the materials of each type of replaced equipment;

e) A report on biosafety incidents which have occurred (if any). The report must specify the time when the indicent occurs, level of the incident and remedial measures taken for the incidents.

2. If the Certificate of Biosafety is damaged or lost, the application shall contain an application form for reissuance of the Certificate of Biosafety using the form provided for in Annex 4 enclosed with this Circular.

3. Regarding application for reissuance of the certificates of biosafety due to change in name of the medical facility having the laboratory, the application shall comprise:

a) An application form for reissuance of the Certificate of Biosafety using the form provided for in Annex 5 enclosed with this Circular;

b) The issued Certificate of Biosafety;

c) Documents proving the change in name of the medical facility: A certified true copy of the establishment decision, applicable to state-owned medical facilities, or a certified true copy of the Certificate of Business registration, applicable to private medical facilities, or the investment certificate, applicable to foreign invested medical facilities.

Article 4. Receipt of applications for issuance/reissuance of Certificates of Biosafety

1. Authorities receiving applications for new Certificates of Biosafety comprise:

a) Medical services divisions of Departments of Health of provinces and central-affiliated cities (hereinafter referred to as Departments of Health of provinces) where the laboratory is located shall receive the application for issuance/reissuance of Certificates of Biosafety Level I and II;

b) The General Department of Preventive Medicine - the Ministry of Health shall receive the application for issuance/reissuance of Certificates of Biosafety Level III and IV.

2. Time of submission:

a) For medical facilities established and operated before the effective date of this Circular: the appraisal of application and issuance of the Certificate of Biosafety shall be carried out before 01/01/2015;

b) For medical facilities established and operated after the effective date of this Circular, the test shall be conducted only when the Certificate of Biosafety has been issued;

c) For application for reissuance of an expired Certificate of Biosafety, the medical facility shall send an application for reissuance of the certificate to a competent agency specified in clause 1 of this Article within 60 (sixty) days before the expiry date of the certificate. Past such time limit, if the application for reissuance of the certificate has not been submitted, the medical facility shall follow the procedures for issuance of the Certificate of Biosafety.

3. When the application has been received, the receiving body shall issue a receipt not using the form provided in Annex 6 of this Circular.

Article 5. Application processing

1. Within 10 (ten) working days from the day on which the application is received, the receiving body shall inspect it.

2. If the application is satisfactory, the receiving body shall:

a) Conduct an on-site inspection within 30 (thirty) working days from the date of receipt of the application;

b) Reissue the Certificate of Biosafety within 10 (ten) working days from the day on which the application is received. If the application is rejected, a written response containing explanation shall be sent.

3. If the application is not satisfactory, within 10 (ten) working days from the day on which the application is received, the receiving body shall send a written notification to the application requesting the completion of the application. The notification shall detail the necessary supplementary contents.

4. When the request for completion of the application has been received, the applicant for issuance/reissuance of the Certificate of Biosafety shall make amendment to the application according to the contents specified in the notification. The date of receipt of the amended application shall be stated on the receipt note. After 10 (ten) working day from the day on which the amended application is received, the receiving body shall complete the inspection of the application or make another request for amendment.

5. If the application has made amendment to the application but the application is still un satisfactory, the receiving body shall notify the application of such for completion according to regulations in clause 3 of this Article.

Article 6. Inspection serving issuance/reissuance of Certificates of Biosafety

1. Directors of Departments of Health of provinces shall decide the establishment of inspectorates serving the issuance/reissuance of the Certificate of Biosafety to level-I and level-II laboratories under their management, which shall comprise:

a) A representative of the Department of Health of province as the Chief;

b) A representative of the Preventive medicine center of province as the deputy Chief;

c) A representative of the Medical services division of the Department of Health;

d) A representative of one of the organizations: the National Institute of Hygiene and Epidemiology, Pasteur Institute of Nha Thang, Pasteur Institute of Ho Chi Minh City or the Institute of Hygiene and Epidemiology of the Central Highlands according the management prescribed by the Minister of Health;

dd) A representative of inspectors of the Department of Health of province;

e) Relevant experts and officers who are invited at the request of the Chief;

g) An expert of the medical services division - the Department of Health as the secretary of the inspectorate.

2. The Minister of Health shall decide the establishment of inspectorates serving the issuance/reissuance of the Certificate of Biosafety to level-III and level-IV laboratories, which shall comprise:

a) A representative of the General Department of Preventive Medicine as the Chief;

b) A representative of the National Institute of Hygiene and Epidemiology as the deputy Chief;

c) A representative of the Legal Department;

d) A representative of the Department of Medical Equipment and Works;

dd) A representative of one of the organizations: the National Institute of Hygiene and Epidemiology, Pasteur Institute of Nha Trang, Pasteur Institute of Ho Chi Minh City or the Institute of Hygiene and Epidemiology of the Central Highlands according the management prescribed by the Minister of Health;

e) A representative of the Department of Health of province where the laboratory applying for the Certificate of Biosafety is located;

g) Relevant experts and officers who are invited at the request of the Chief;

h) An expert of General Department of Preventive Medicine as the secretary of the inspectorate.

3. The standing office of the inspectorate specified in Clause 1 of this Article shall be at the Medical services division - the Department of Health of province. The standing office of the inspectorate specified in Clause 2 of this Article shall be at the General Department of Preventive Medicine - the Ministry of Health.

Article 7. Inspection procedures

1. Procedures for inspection serving the issuance of Certificates of Biosafety:

a) Inspection of legal dossiers: inspection of conditions of facilities, equipment, personnel of the laboratory applying for the Certificate of Biosafety;

b) On-site inspection and formulation of inspection record for level-I, level-II, level-III and level-IV laboratories using the forms in Annex 7, Annex 8, Annex 9 and Annex 10 enclosed with this Circular;

c) The inspection record specified in point b of this Clause and the documents on remedial measures (if any) shall be retained as follows:

- For laboratories under the management of the Ministry of Health: the inspection records shall be made in 03 sets, 01 of which shall be retained at the Ministry of Health, another shall be retained at the Department of Health of province where the laboratory is located, the other shall be retained at the office of the applicant;

- For laboratories under the management of the Director of the Department of Health of province: the inspection records shall be made in 02 sets, 01 of which shall be retained at the Department of Health of province, the other shall be retained at the office of the applicant.

2. Procedures for inspection serving the reissuance of Certificates of Biosafety:

a) Inspection of the inspection record serving the issuance of the old certificate which is retained at the Ministry of Health or the Department of Health of province or the damaged certificate (if any) and documents specified in Article 3 of this Circular;

b) In case of necessuty, an on-site inspection at the laboratory shall be conducted at the request of the standing office of the inspectorate and the Certificate of Biosafety shall be issued.

3. Management of the certificates of biosafety:

a) Any laboratory shall be issued with only 1 Certificate of Biosafety using the form in Annex 11 enclosed with this Circular;

b) Applications for issuance/reissuance of certificates of biosafety shall be retained at the issuing bodies;

c) When the Certificate of Biosafety has been issued to the applicant:

- Within 30 (thirty) days from the day on which the Certificate of Biosafety is issued/reissued, the Ministry of Health shall send a written notification to the People’s Committee of province and the Department of Health of province where the applicant is located;

- Within 30 (thirty) days from the day on which the Certificate of Biosafety is issued/reissued, the Department of Health of province shall send a written notification to the People’s Committee of district, town or provincial-affiliated city where the applicant is located.

Article 8. Fees for issuance/reissuance of Certificates of Biosafety

1. Any applicant for the Certificate of Biosafety shall pay the fees for issuance of the Certificate at the time of submission of the application.

2. The collection, management and use of fees for issuance of the Certificate of Biosafety shall comply with regulations of the Ministry of Finance.

Article 9. Effect

This Circular comes into effect from February 01, 2013

Article 10. Responsibilities

1. The Director of General Department of Preventive Medicine, the Director of the Department of Medical Equipment and Works, the Director of the Legal Department, within their functions, tasks and powers, shall cooperate with relevant Departments and General Departments in conducting inspection of the issuance/reissuance of the Certificate of Biosafety and the compliance with laws of medical facilities having laboratories.

2. Directors of Departments of Health shall conduct inspection of the issuance/reissuance of Certificates of Biosafety and the compliance with laws of medical facilities having laboratories within their management.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (via General Department of Preventive Medicine) for consideration.