Vietnam: Application for reissuance of biosafety certificate

According to Clause 14 Article 1 of Decree No. 118/2020/NĐ-CP of Vietnam’s Government supplementing Article 28a after Article 28 of Decree No. 69/2010/NĐ-CP, certification of genetically modified organisms’ eligibility for use as food shall be reissued in following cases:

- Changes to information of the organizations under issued certification of genetically modified organisms’ eligibility for use as food;

- Lost, damaged or worn-out certification of genetically modified organisms’ eligibility for use as food.

Application for reissuance consists of:

- Written application using Form No. 11 under Annex attached to this Decree;

- Certification of genetically modified organisms’ eligibility for use as food previously issued in case of changes to information on the organizations or damaged or worn-out permit;

- Documents proving changes for cases specified under Point a Clause 1 of this Article.

Applicants shall submit 1 application for reissuance to the Ministry of Agriculture and Rural Development in person, via postal service or via the internet. Within 07 working days from the date on which adequate applications are received, the Ministry of Agriculture and Rural Development shall consider reissuing certification of genetically modified organisms’ eligibility for use as food.

Besides, according to Clause 13 Article 1 of Decree No. 118/2020/NĐ-CP of Vietnam’s Government supplementing Article 28 of Decree No. 69/2010/NĐ-CP, an applicant for a written certification of genetically modified organisms' eligibility for use as food shall submit three (3) dossier sets to the Ministry of Health. Such a dossier comprises:

- An application for a written certification of genetically modified organisms' eligibility for use as food, made according to the form specified by the Ministry of Health;

- A report on assessment of risks of genetically modified organisms to human health, made according to Appendix V to Decree No. 69/2010/NĐ-CP;

- With respect to genetically modified organisms specified under Clause 2 Article 27 of Decree No. 69/2010/NĐ-CP, provide original copies or certified true copies and certified Vietnamese translation of confirmation documents or equivalent documents of competent agencies permitting genetically modified organisms to be used as food in at least 5 developing countries;

- Summary of risk assessment reports (together with electronic form) of genetically modified organisms for human health using Form No. 10 under Annex attached to Decree No. 118/2020/NĐ-CP;

- Reference and research scientific texts that have not been published, other assessment, test or scientific figures (if any) which are used by the applicants as the basis to conclude that the genetically modified organisms do not negatively affect human health.

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

Le Vy

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