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MEKONG COUNSEL

Circular on procedures for new issue, re-issue of certificates of bio-safety laboratories

On December 04, 2012, the Ministry of Health issued Circular No. 29/2012/TT-BYT on procedures for new issue, re-issue of certificates of bio-safety laboratories (“CBSL”). Accordingly, an establishment with a laboratory of all levels applying for new issue of a CBSL shall submit dossiers to the managerial agency as regulated for appraisal and issuance of the CBSL before January 01, 2015 if the establishment has been set up and operated prior to the effective date of this Circular; if the establishment is set up and operated after the effective date of this Circular, it shall be permitted to operate only after the CBSL is issued.

 

- Dossiers for new issue of a CBSL shall include:

 

+ Laboratory level I: (1) Application Form (under a set form); (2) List of personnel (under a set form); (3) List of equipment (under a set form); (4) Layout of the laboratory; (5) Enterprise Registration Certificate and operation permit (if any).

 

+ Laboratory level II: the following dossiers are required to supplement: (6) Layout of waste water treatment system and test result of waste water which meets the national technical regulation on environment; (7) Specifications of materials designed for each type of door and window; (8) Specifications of materials designed for each type of equipment used in electricity and water systems; (9) Report on maintenance of the laboratory equipment and devices.

 

+ Laboratory level III and level IV: the following dossiers are required to supplement: (10) Design of liquid waste treatment system using chemicals and test result which meets the national technical regulation on environment; (11) Design together with specifications of materials designed for each type of device used in air ventilation system.

 

- Dossiers for re-issue of a CBSL shall include:

 

+ Application Form (under a set form);

 

+ The original CBSL (in case the CBSL is expired or worn, or the establishment’s owner is changed);

 

+ Reports on changes in personnel, equipment and devices, materials and facilities, and on incidents relating to biosafety that happened;

 

+ Enterprise Registration Certificate (of the new owner).

 

- Agency to receive the dossiers

 

+ Medical Profession Division under the provincial Department of Heath shall receive the dossiers of laboratories of level I and level II;

 

+ Department of Preventive Medicine of Vietnam under the Ministry of Health shall receive the dossiers of laboratories of level III and level IV.

 

- Time limit for consideration, issuance of a CBSL shall be 50-60 working days after the agency in charge receives valid dossiers of the establishment in full.

 

Remarks: Files attached.

 

This Circular shall be effective from February 01, 2013.