Vietnam: Application for issuance of permit for testing genetically modified organisms

Recently, the Government of Vietnam has issued Decree No. 118/2020/NĐ-CP on amendments to Decree No. 69/2010/NĐ-CP dated June 21, 2020 of Vietnam’s Government on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms.

Hồ sơ đăng ký cấp Giấy phép khảo nghiệm sinh vật biến đổi gen, Nghị định 118/2020/NĐ-CP

According to Clause 8 Article 1 of Decree No. 118/2020/NĐ-CP of Vietnam’s Government amending Article 18 of Decree No. 69/2010/NĐ-CP, entitlement and procedures for issuance and revocation of permit for testing genetically modified organisms are specified as follows:

- The Ministry of Agriculture and Rural Development shall issue and revoke permits for testing genetically modified organisms.

- Applicants shall submit 1 application to the Ministry of Agriculture and Rural Development in person, via postal service or via the internet. Application includes:

+ Written application for issuance of permit for testing genetically modified organisms using Form No. 4 under Annex attached to this Decree;

+ Explanation of application for testing genetically modified organisms and testing plans specified under Annex II and Annex III of Decree No. 69/2010/NĐ-CP. With respect to genetically modified plants, adopt Form No. 5 under Annex attached to this Decree;

+ Copies of Decisions on accrediting genetically modified organism testing bodies;

+ In case genetically modified organisms are imported to be tested and assessed for risks, documents proving such genetically modified organisms have been permitted for use by countries around the world are required in order for the genetically modified organisms to be released into the environment. In case genetically modified organisms are created domestically, documents proving such genetically modified organisms are results of scientific research accredited by competent authorities are required.

- Within 7 working days from the date on which application is received, the Ministry of Agriculture and Rural Development shall inform the applicants in writing about accepting applications or requesting revision; revision period shall not be included in application appraisal period.

- Within 30 days for applications for issuance of permit for limited testing and 45 days for applications for issuance of permit for large-scale testing from the date on which adequate applications are received, the Ministry of Agriculture and Rural Development shall organize the Council to appraise the applications. Appraisal results of the Council for testing and assessing genetically modified organisms shall serve as the basis for the Ministry of Agriculture and Rural Development to consider issuing permit for testing genetically modified organisms.

- Within 10 days from the date on which appraisal results are available, the Ministry of Agriculture and Rural Development shall consider issuing permit for testing genetically modified organisms. In case of rejection, the Ministry of Agriculture and Rural Development shall inform the applicants and specify reasons in writing.

- The Ministry of Agriculture and Rural Development shall take charge and cooperate with Ministry of Natural Resources and Environment in examining compliance with requirements of permit for testing genetically modified organisms.

- Ministry of Agriculture and Rural Development shall consider revoking permit for testing genetically modified organisms if the organizations issued with the permit commit any of the following violations:

+ Providing false information on name of genetically modified organisms;

+ Conducting tests at the wrong time, in the wrong places with scale not agreed upon by Ministry of Agriculture and Rural Development;

+ Failing to comply with explanation for application for testing genetically modified organisms.

Note: Within 10 days from the date on which decisions on issuance or revocation of permit for testing genetically modified organisms, the Ministry of Agriculture and Rural Development shall send 1 original copy to the Ministry of Natural Resources and Environment and publicize the decisions on the website of Ministry of Agriculture and Rural Development.

View details at Decree No. 118/2020/NĐ-CP of Vietnam’s Government, effective from October 02, 2020.

Le Vy

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