Chapter III
SCIENTIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT REGARDING GENETICALLY MODIFIED ORGANISMS AND PRODUCTS THEREOF
Article 10. Requirements on scientific research and technological development regarding genetically modified organisms and products thereof
1. Scientific research and technological development regarding genetically modified organisms and products thereof must comply with current regulations on scientific and technological management and other relevant regulations.
2. Research activities to create, analyze and test in isolation genetically modified organisms and products thereof may be carried out only in genetically modified organism laboratories accredited by the Ministry of Science and Technology under Articles 11 and 12 of this Decree
Article 11. Conditions on genetically modified organism laboratories
1. A genetically modified organism laboratory must fully satisfy the following conditions:
a/ Having suitable professional staff for conducting scientific research and technological development regarding genetically modified organisms and products thereof;
b/ Having suitable equipment for scientific research and technological development regarding genetically modified organisms and products thereof;
c/ Having an operating process which satisfies biosafety requirements.
2. The Ministry of Science and Technology shall specifically guide Clause 1 of this Article.
Article 12. Competence, order and procedures to accredit, or revoke decisions accrediting, genetically modified organism laboratories
1. The Ministry of Science and Technology shall accredit, or revoke decisions accrediting. genetically modified organism laboratories.
2. An organization registering for the accreditation of a genetically modified organism laboratory shall submit three (3) dossier sets to the Ministry of Science and Technology. Such a dossier comprises:
a/ A written registration for accreditation of a genetically modified organism laboratory, made according to the form set by the Ministry of
Science and Technology;
b/ Copies of all decisions on the organization's functions and tasks:
c/ Explanations about the laboratory's capability, made according to the form set by the Ministry of Science and Technology;
d/ Relevant documents evidencing the laboratory's satisfaction of the conditions specified in Article 11 of this Decree.
3. Within 7 working days after receiving a dossier, the Ministry of Science and Technology shall notify its acceptance of the valid dossier to the registering organization or request the organization to supplement and complete the dossier under regulations. The time for dossier supplementation and completion will not be included in the time for dossier appraisal.
4. Within 45 days after receiving a valid dossier of registration for accreditation of a genetically modified organism laboratory, the Ministry of Science and Technology shall set up a council to appraise the dossier.
The council's appraisal results serve as a basis for the Minister of Science and Technology to decide to accredit a genetically modified organism laboratory.
5. Within 30 days after obtaining appraisal results, the Minister of Science and Technology shall examine them and accredit a genetically modified organism laboratory. In case of refusal, he/she shall issue a written notice clearly stating the reason to the registering organization.
6. The Ministry of Science and Technology shall guide in detail the order and procedures for accrediting genetically modified organism laboratories and periodically examine the operation of these laboratories. In case a genetically modified organism laboratory fails to satisfy any of the conditions specified in Article 11 of this Decree, the Ministry of Science and Technology shall consider the case and revoke a decision accrediting such laboratory.
7. The Ministry of Science and Technology shall notify the Ministry of Natural Resources and Environment and relevant line ministries of the accreditation of. or revocation of decisions accrediting, genetically modified organism laboratories.
Article 13. Biosafety in scientific research and technological development regarding genetically modified organisms and products thereof
1. Scientific research and technological development regarding genetically modified organisms and products thereof must be conducted within the framework of approved projects under law. A project on scientific research and technological development regarding genetically modified organisms created from donor organisms and host organisms which are likely to greatly affect the environment, biodiversity or health of humans and domestic animals must be licensed by the Ministry of Science and Technology.
2. An explanatory document on a project on scientific research and technological development regarding genetically modified organisms and products thereof must contain biosafety details. In case such a project requires import of genetically modified organisms for scientific research and technological development, its explanatory document must contain the information specified in Appendix 1 to this Decree.
3. Genetically modified organism laboratories must observe biosafety regulations.
The Ministry of Science and Technology shall specify contents of biosafety in genetically modified organism laboratories.
Tìm kiếm
Nghị định 69/2010/NĐ-CP (Bản Word)
Nghị định 69/2010/NĐ-CP (Bản Pdf)