Application for accreditation of GMO laboratories in Vietnam

According to Article 11 of the Circular No. 20/2012/TT-BKHCN of the Ministry of Science and Technology of Vietnam, application for accreditation of GMO laboratories (genetically modified organisms) consists of:

- P4-DK form prescribed in Appendix II issued together with Circular No. 20/2012/TT-BKHCN;

- A copy of the decision on establishment, role and objectives of the applicant;

- A copy of decision on establishment of the GMO laboratory and other documents related to GMO laboratory;

- Description of ability of the GMO laboratory (using P5-NL form prescribed in Appendix II issued together with Circular No. 20/2012/TT-BKHCN);

- Summary of activities of the organization owning the GMO laboratory, permanent employees’ scientific résumé, certificate of training in biosafety (using P6-NLTC,P7-NLCN and P8-CC forms prescribed in Appendix II issued together with Circular No. 20/2012/TT-BKHCN);

- A copy of certificate of equipment’s origin and certificate of inspection and calibration of equipment (if any);

- By-Laws on operating the laboratory.

Note: Quantity of documents that shall be submitted: 01 original file, 02 copies and 01 electronic file.

Concurrently, according to Article 12 of the Circular No. 20/2012/TT-BKHCN of the Ministry of Science and Technology of Vietnam, within 45 working days from the day on which the valid application is received, Ministry of Science and Technology shall establish the Inspection Board and organize the Inspection. Form P9-PNX in Appendix III issued together with this Circular shall be sent to members of the Inspection Board at least 05 days before site inspection and 10 days before the Meeting of Inspection Board. Composition and principles of Inspection Board are as follows:

- The Inspection Board shall include from 07 to 09 members: Chairperson who is the Director of Department of Science and Technology for Economic-Technical Branches; 01 Vice chairman and 02 critics who are professors in biological technology; 01 secretary who is a specialist of Department of Science and Technology for Economic-Technical Branches and 01 representative of the supervisory authority of the GMO laboratory or the supervisory authority of the applicant. Other members are deeply professional in biological technology. Site inspection group shall include a group leader and 02 members;

- Every meeting of the Inspection Board shall be attended by at least two-third of its members, including Chairman or Vice Chairman, 02 critics and 01 secretary. The Inspection Board considers fulfillment of conditions for accreditation by GMO laboratory in accordance with requirements prescribed in Chapter II and Chapter III of this Circular, the application and the site inspection record. Members of the Inspection Board are responsible for inspecting correctly and objectively and also take responsibility for the Inspection Board’s conclusion and suggestion.

View more details at the Circular No. 20/2012/TT-BKHCN of the Ministry of Science and Technology of Vietnam, effective from January 04, 2013.

Le Vy

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