RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of March 4, 1996 No. 295

About approval of the Procedure for carrying out the state testing, the state registration and re-registration, the edition of lists of the pesticides and agrochemicals permitted to use in Ukraine

According to articles 5 and 7 of the Law of Ukraine "About pesticides and agrochemicals" the Cabinet of Ministers of Ukraine DECIDES:

Approve the Procedure for carrying out the state testing, the state registration and re-registration, the edition of lists of the pesticides and agrochemicals permitted to use in Ukraine it (is applied).

Approved by the Resolution of the Cabinet of Ministers of Ukraine of March 4, 1996, No. 295

Procedure for carrying out the state testing, state registration and re-registration, edition of lists of the pesticides and agrochemicals permitted to use in Ukraine

1. This Procedure establishes requirements to carrying out the state testing, the state registration and re-registration, the edition of lists of the pesticides and agrochemicals permitted to use in Ukraine (further - medicines).

State testing of medicines

2. The state testing of new medicines are carried out for the purpose of biological, toksikologo-hygienic and ecological assessment and development of standard rates and regulations of their safe application.

The state testing of medicines are carried out to representatives of Minekoenergo research establishments, the companies and the organizations, at the same time toksikologo-hygienic (medicobiological) researches - by the approved techniques in organizations, certain by Gosprodpotrebsluzhboy.

The procedure for authorization of research establishments, companies and organizations on carrying out the state testing of medicines affirms Minekoenergo.

3. The state approbations of medicines with new active ingredient are carried out throughout two complete vegetative periods. Research of new medicines which did not join in the plan of the state testing, but were carried out by the research establishments, the companies and the organizations specified in Item 2, is the beginning of the state testing (on condition of positive conclusions of the specified research establishments, the companies and the organizations). Such medicines join in the plan of the state testing for the next calendar year.

By results of field trials of Ministry for Protection of the Environment and Natural Resources determines amounts of carrying out the state testing, and in case of not establishment or non-confirmation of biological efficiency of medicine in comparison with those which are already applied, makes the decision on removal of medicine from further state testing.

4. If the medicine provided on the state testing contains active ingredient which is part of already registered medicine of the same assignment and for the same group of cultures, the term of the state testing can be reduced to one complete vegetative period. For nitrogen fertilizers which contain active ingredient which is part of already registered medicine of the same assignment and for the same group of cultures the state testing can be replaced with retsenzionny reports from the organizations entering into networks of the state testing of medicines, and documentation provided by the applicant on medicine and active ingredient.

5. The state testing of medicines for glass-covered ground, fumigation of storage facilities and inventories of grain, fight against mouse-like rodents and household insects are carried out for up to one year.

6. During the state testing of medicines by organizations of the Ministry of Health toksikologo-hygienic assessment of medicine and conditions of its application is given, necessary hygienic standard rates and regulations are developed.

7. Organizations which are included into network of the state testing of medicines in case of need develop the most admissible levels (MAL) in sterns, the maximum permissible levels (MPL) or the approximate admissible levels (AAL) in water of reservoirs of fishery assignment, PDU in sterns for bees.

8. During the state testing of medicines the group of experts on technique of determination of residual amount of medicines and metabolites under Ministry for Protection of the Environment and Natural Resources approves methods of determination of residual amount of medicines, their toxic metabolites in the soil, water, air, plants, sterns, food and MZ and approval of Ministry for Protection of the Environment and Natural Resources submits them for approval.

Ministry for Protection of the Environment and Natural Resources develops and claims in coordination with MZ of technique of determination of compliance of medicines to quality certificates.

9. For inclusion of medicine in the plan of the state testing the subject of managing (further - the applicant) files Minekoenergo the following documents:

petition for inclusion of medicine in the plan;

the request for testing of medicine in Ukrainian in the form approved by Minekoenergo, in duplicate;

the power of attorney on representation which is granted right to sign and powers of submission of documents (in case of need);

materials (file) based on which the request for testing, in the Ukrainian or English or Russian languages in one copy is constituted;

the project of specifications on production of pilot run in duplicate - for domestic medicines.

Minekoenergo provides storage of materials (file) for medicine registration.

In case of submission of documents by the applicant concerning medicines which producer is the other person, and/or the medicines containing active ingredients which producer are other persons - the document from the producer or the owner of medicine and/or active ingredient by which the right of the applicant to represent its interests during implementation of the state testing of medicine is confirmed.

The documents submitted in foreign language shall be certified them by developer, and copies of documents - are assured of the procedure established by the legislation.

10. The petition for inclusion of medicines in the plan of the state testing the current year Ministries for Protection of the Environment and Natural Resources till March 25 of the current year are accepted. The petition for inclusion of nitrogen fertilizers in the plan of the state testing the current year Ministries for Protection of the Environment and Natural Resources within year are accepted.

11. Materials of applicants pass the examination in Gosprodpotrebsluzhbe till 45 calendar days, at the same time amounts of necessary researches and the list of research establishments, companies and organizations (further - the contractor) which according to Item 2 of this Procedure will carry out the state testing of medicines which are approved by Minekoenergo are determined.

On experimental testimony medicine is considered approved with Gosprodpotrebsluzhboy before inclusion in the plan of the state testing.

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