Gov't shortens time required for grant of license for assay of genetically modified organisms
10:15 | 08/10/2020
The Government has promulgated Decree No. 118/2020/ND-CP amending and supplementing a number of articles of Decree No. 69/2010/ND-CP dated on June 21/2010 on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms.

Under the new Decree, the Ministry of Agriculture and Rural Development shall grant or revoke licenses for assay of genetically modified organisms.

An applicant for a license for assay of genetically modified organisms shall submit three dossier sets to the Ministry of Agriculture and Rural Development, which include:

(i) An application for the license, made according to the form set by the Ministry of Agriculture and Rural Development.

(ii) An explanatory document about registration of the assay of genetically modified organisms, containing the information specified in Appendix II to this Decree.

(iii) A plan on the assay of genetically modified organisms, made according to Appendix III to this Decree.

(iv) A copy of the decision accrediting the genetically modified organism assaying institution.

(v) For genetically modified organisms imported for assay, they must have documents evidencing that they are permitted by exporting country for use for the same purpose in the territory of this country. For genetically modified organisms created domestically, they must have documents evidencing that they are scientific research outcomes recognized by a competent state agency.

(vi) The Ministry of Agriculture and Rural Development’s document recognizing restricted assay results, in case of registration of wide-area assay.

Within five working days (current seven working days) after receiving a dossier, the Ministry of Agriculture and Rural Development shall notify its acceptance of the valid dossier to the applicant or request the applicant to supplement and complete the dossier under regulations.

Within 45 days (currently 60 days) after receiving a valid dossier of application for a license for assay of genetically modified organisms, the Ministry of Agriculture and Rural Development shall set up a council to appraise the dossier.

The council’s appraisal results serve as a basis for the Minister of Agriculture and Rural Development to grant a license for assay of genetically modified organisms.

Within 10 days (currently 30 days) after obtaining appraisal results, the Minister of Agriculture and Rural Development shall examine them and grant a license for assay of genetically modified organisms. In case of refusal, the Ministry of Agriculture and Rural Development shall issue a written notice clearly stating the reason to the applicant./.

By Huong Giang

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