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HIGHLIGHTS

LAW

Law of Ukraine "About pesticides and agrochemicals".
The procedure for state registration, re-registration and testing, Resolution of the Cabinet of Ministers of Ukraine dated 04.04.1996, No. 295.

According to the Law, pesticides and agrochemicals that have not passed the registration process are prohibited in Ukraine, the only exception are "pure" mineral fertilizers that do not contain trace elements. For the sale of such fertilizers, it is necessary to obtain only the conclusion of the sanitary and epidemiological examination.
 

Foreign-made pesticides and agrochemicals (imported into the territory of Ukraine), as well as those produced in Ukraine for sale, use in agriculture and the agricultural sector, must be tested and entered into the Register of pesticides and agrochemicals permitted for use in Ukraine.

State registration of pesticides and agrochemicals in Ukraine is carried out by the Ministry of Environmental Protection and Natural Resources of Ukraine.

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Agrochemicals are not subject to registration, which are determined by the "List of agrochemicals allowed for import into the customs territory of Ukraine, production, trade, use and advertising without their state registration." Most of these are nitrogen fertilizers, or fertilizers, the composition of which has long been known and studied.

IMPORTANT

Deadline for submission of documents for inclusion in the test plan

When planning the registration procedure, it is important to take into account that in the procedure for conducting state tests, the deadline for submitting documents for inclusion in the test plan is set until March 25 for the current year.
But due to the fact that registration will include the collection of a dossier, which consists of a large package of documents, and preparation for registration and collection of the dossier can be done at any convenient time.

TIME

Period for which registration is valid

The maximum possible period for which the registration of fertilizers and pesticides is carried out on the territory of Ukraine is 10 years.

There are two main types of registration:

  • Experimental registration is approved for 2 years

  • Permanent registration is approved for
    2 years , 5 years , 10 years

INFORMATION

To estimate the amount of work needed and to budget

Should be provided:

  • quality certificate of the formulation,

  • safety sheet (MSDS), TU (technical conditions);

  • the scope of application of the drug in Ukraine;

  • mode of application;

  • the period for which registration is planned;

  • culture and application rates of the drug;

  • reports on biological, toxicological and environmental studies (if any).

DOCUMENTS

To prepare an application for inclusion in the state test plan

Should be provided:

  • quality certificate (composition), formulation (product);

  • active ingredient quality certificate (for pesticides);

  • Safety Data Sheet (MSDS);

  • Safety Data Sheet (MSDS) (for pesticides that are formulated in Ukraine);

  • A letter of approval (power of attorney) from the manufacturer of the drug for registration in Ukraine;

  • Certified scanned copy of the product registration certificate (formulation) in the manufacturer's country;

  • Product dossier: reports of research institutes on the conducted government trials of the drug.


* The number of studies differs depending on the product.

To apply for state registration of drugs

You must provide:

  • application for state registration of the drug in Ukrainian - 2 copies;

  • materials (dossier) on the basis of which the application for registration of the drug is drawn up, drawn up according to sections and paragraphs of the application, in Ukrainian, English or Russian - 2 copies;

  • a certificate of the constancy of the composition of the drug, the state (industry) standard or technical specifications for the active substance and the form of the drug - 2 copies (for domestic drugs);

  • reports on the results of state tests of the drug - 2 copies;

  • guidelines for determining the content of residual amounts of pesticides in agricultural products, soil, water, air and methods for determining the compliance of pesticides and agrochemicals with quality certificates - 2 copies;

  • draft packaging label with instructions for the safe use of the drug - 2 copies.

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* When registering a drug intended for retail sale to the public, the applicant also submits a description of the container.

PROCEDURE

entering into the Register of pesticides and agrochemicals

Consists of:

  • collection of documents on the composition, efficiency and application of fertilizers;

  • preparation, organization and support of tests;

  • verification of documents, test results and inclusion in the Register.

RESULT

registration

In the presence of positive results of examinations and recommendations of the scientific expert council, the Ministry of Ecology decides on the state registration of the drug, which, as a result, is entered into the State Register of Pesticides and Agrochemicals.

The applicant is issued a letter of notification of state registration of the drug and a container label.

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