Enactment of the council of ministers of the republic of belarus
|
| Registered in the National Register of Legal Acts of the Republic of Belarus, September 15, 2006, № 5/22920 ENACTMENT OF THE COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS September, 12, 2006, № 1195 ON APPROVAL OF THE REGULATION ON THE STATE REGISTRATION PROCEDURE OF genetically engineered plants varieties, genetically engineered species of animals and races of nonpathogenic genetically engineered microorganisms The Council of Ministers of the Republic of Belarus enacts: 1. Approve the enclosed Regulation on the state registration procedure of genetically engineered plants varieties, genetically engineered species of animals and races of nonpathogenic genetically engineered microorganisms. 2. The current enactment comes into operation since the moment of its official promulgation. First Deputy Prime Minister Of the Republic of Belarus V.Semashko APPROVED Enactment of the Council of Ministers of the Republic of Belarus September 12, 2006, № 1195 ^ genetically engineered plants varieties, genetically engineered species of animals and races of nonpathogenic genetically engineered microorganisms 1. The present regulation is worked out in accordance with the Act of the Republic of Belarus from January 9, 2006 “On genetic engineering activities safety” (the National Register of Legal Acts of the Republic of Belarus, 2006, № 9, 2/1193). It regulates the order of the state registration of genetically engineered plants varieties, genetically engineered species of animals and races of nonpathogenic genetically engineered microorganisms (onwards – “genetically engineered plants, animals and microorganisms”) for industrial use. 2. The state registration of genetically engineered plants, animals and microorganisms for industrial use (onwards – “state registration”) is performed by the Ministry of Agriculture and Foodstuffs of the Republic of Belarus. 3. For the completion of the state registration procedure, according to the present Regulation, legal bodies and individual entrepreneurs, residents of the Republic of Belarus (onwards – “applicants”), present to the Ministry of Agriculture and Foodstuffs of the Republic of Belarus the application for the state registration and the following documents: Conclusion of the state inspection for genetically engineered organisms safety; Recommendation of the inspection council for genetically engineered organisms safety of the Ministry of Natural Resources and Ecology of the Republic of Belarus; Data on the results of state experiments with genetically engineered plants, animals and microorganisms; Copies of constituent documents of legal bodies or an individual entrepreneur state registration certificate; Description of the offered genetically engineered plants, animals and microorganisms; Application form for genetically engineered plants, animals and microorganisms; Brief annotation on genetically engineered plants, animals and microorganisms; Statement on constructive participation of each co-author including their participation interest in the creation of genetically engineered plants, animals and microorganisms, approved by the applicant’s scientific (scientific-technical) council, and a and extract from the current session protocol on the commitment of genetically engineered plants, animals and microorganisms to the state registration; Photos, negatives (reverses) or digital image copies of genetically engineered plants, animals and microorganisms (one issue) with white background with a graduated scale of reproductive plant segments and normally developed plants, animals and microorganisms for industrial use. 4. The applicant, to register new genetically engineered plants, animals and microorganisms bred by means of traditional selection using genetically engineered plants, animals and microorganisms, already included in the state register of genetically engineered plants varieties, genetically engineered species of animals and races of nonpathogenic genetically engineered microorganisms (onwards – “register”) as the parent material, presents the application enclosing the documents provided in the first, fourth – tenth paragraphs of article 3 of the present Regulation. 5. The register is an integrated data pool on genetically engineered plants varieties, genetically engineered species of animals and races of nonpathogenic genetically engineered microorganisms used by legal bodies and individual entrepreneurs with industrial purposes. 6. The register is executed by the Ministry of Agriculture and Foodstuffs of the Republic of Belarus. 7. One of the requirements for the inclusion of genetically engineered plants, animals and microorganisms in the register is the positive conclusion of the state inspection for safety of genetically engineered plants, animals and microorganisms and the positive results of experiments with genetically engineered plants, animals and microorganisms. 8. The register includes the following information: Registration number of the application presented to the state registration of genetically engineered plants, animals and microorganisms; Title of genetically engineered plants, animals and microorganisms; The year of the state registration of genetically engineered plants, animals and microorganisms; The registration number of a legal body or an individual entrepreneur who presented the application for state registration of genetically engineered plants, animals and microorganisms, assigned by the Ministry of Agriculture and Foodstuffs; The region where genetically engineered plants, animals and microorganisms are approved for industrial use; The universal identification for genetically engineered plants, animals and microorganisms; Genetic characteristics for genetically engineered plants, animals and microorganisms; Industrial - biological characteristics for genetically engineered plants, animals and microorganisms. 9. The suppression of genetically engineered plants, animals and microorganisms from the register occurs in the following cases: Their nonuse with industrial purposes within the period of three last years; Fore-fault of their economic value; Their adverse effect on human health and the environment. 10. The suppression from the register is carried out upon the decision of the Ministry of Agriculture and Foodstuffs as devised by state organizations in its subordination and other state bodies. 11. The information on inclusion of genetically engineered plants, animals and microorganisms in the register and their suppression from it is presented to the state science establishment “Institute of genetics and cytology of the National academy of sciences of the Republic of Belarus” within 5 days since the relevant decision is made. 12. The register is published annually by the Ministry of Agriculture and Foodstuffs of the Republic of Belarus. 13. The application is composed in Russian or Belarusian and printed in accordance with the form approved by the Ministry of Agriculture and Foodstuffs of the Republic of Belarus. As advised by state establishments authorized to perform experiments with genetically engineered plants, animals and microorganisms. 14. Consideration of the application with enclosed documents is performed by the Ministry of Agriculture and Foodstuffs of the Republic of Belarus within 30 days since the moment of its submission. 15. In case of necessity the Ministry of Agriculture and Foodstuffs can request some additional documents (needed for decision making on registration of genetically engineered plants, animals and microorganisms) from the applicant. All the requested documents are to be presented by the applicant within 30 days since the request received. In case of non-presentation of the requested documents the application for registration of genetically engineered plants, animals and microorganisms cannot be taken into consideration. 16. The Ministry of Agriculture and Foodstuffs issues the state registration certificate to the applicant within 10 days since the relevant decision made, in the form approved by the current ministry. 17. Information on state registration of genetically engineered plants, animals and microorganisms is annually published by the Ministry of Agriculture and Foodstuffs in the Register. 18. In case of any amendments and (or) additions to the constituent documents of legal bodies or to the state registration certificate of an individual entrepreneur, a legal body or an individual entrepreneur is obliged to submit an application for inclusion of these amendments and (or) additions in the state registration certificate enclosing copies of the constituent documents of a legal body or a state registration certificate of an individual entrepreneur to the Ministry of Agriculture and Foodstuffs within 15 days since the moment of registration of the amendments and (or) additions, 19. The Ministry of Agriculture and Foodstuffs considers the presented documents for amendments and (or) additions to the state registration certificate and makes a relevant decision in form approved for the state registration procedure. 20. In case of loss of the state registration certificate, legal bodies and individual entrepreneurs have the right to get its duplicate within 15 days since the claim. 21. The state registration certificate can be abolished and genetically engineered plants, animals and microorganisms suppressed from the register in case of their adverse effect on humans’ health or the environment approved by the state inspection carried out by the initiative of state administration bodies, public associations and individual citizens. 22. The Ministry of Agriculture and Foodstuffs informs the state science establishment “Institute of Genetics and Cytology of the National Academy of Sciences of the Republic of Belarus” about the abolition of the state registration certificate and suppression of genetically engineered plants, animals and microorganisms from the Register within 10 days since the relevant decision made. |
