of November 21, 2007 No. 1349
About approval of regulations on the state registration of veterinary medicines, feed additives, premixes and ready-made feeds
According to articles 63 and 76 of the Law of Ukraine "About veterinary medicine" the Cabinet of Ministers of Ukraine decides:
Approve such which are applied:
The paragraph third ceased to be valid according to the Resolution of the Cabinet of Ministers of Ukraine of 03.03.2020 No. 210;
Prime Minister of Ukraine
The regulations on the state registration of veterinary medicines voided according to the Resolution of the Cabinet of Ministers of Ukraine of 03.03.2020 No. 210
Approved by the resolution of the Cabinet of Ministers of Ukraine of November 21, 2007 No. 1349
1. This Provision establishes the mechanism of the state registration of feed additives, premixes and ready-made feeds (further registration).
2. Registration performs Goskomvetmeditsina based on the given owner of the registration file or its representative (further - the applicant) statements, decisions of the State pharmacological commission of veterinary medicine and expert conclusion of the National agency of veterinary medicines and feed additives (further - the agency).
The owner of the registration file is the legal entity who provides data collection and processing about all cases of negative reactions of feed additives, premixes and ready-made feeds (further - product).
3. Registration of product which can worsen veterinary and sanitary and epizootic condition is forbidden or do harm to human health or animals, in particular to health of the consumer by deterioration in characteristics of animal products, and also can create wrong idea of them at the consumer.
4. Goskomvetmeditsina's decisions on registration (re-registration), suspension or cancellation of registration of separate product can be appealed in court.
Product order of registration
5. For conducting examination of the registration file (daleeekspertiz) and registration of product the applicant submits to the agency the application for conducting examination of product together with the registration file.
6. The registration file is set of the analytical regulating documentation, documents of specialized assessment (certificates, accreditations, instructions on safety and remaining balance of products, materials of the conducted clinical trials). The applicant together with the registration file gives also product samples.
7. For implementation of registration (re-registration) the applicant submits on each pharmaceutical (biological) form, concentration or compounding of product the separate statement on conducting examination and the registration file.
The application form, the list of materials of the registration file and procedure for its forming are established Goskomvetmeditsina.
8. The agency checks completeness and exhaustibility of the given materials and makes the decision on adoption of the registration file on examination or return to his applicant for completion.
9. The agency carries out expertize on contractual basis in time which does not exceed 90 days of the date of receipt of the statement, set of documents in full and implementation of the corresponding payment.
10. The agency determines need and amount of carrying out registration testing and the need for conducting check for product conditions of production, organizes carrying out necessary researches, takes other measures for the verification of information and data noted in documents and also prepares expert conclusions.
For the purpose of receipt of additional data on efficiency, safety and product quality the agency can request during conducting examination from the applicant additional documents and materials. Time necessary for their preparation is not set off to the term allotted for conducting examination.
During registration testing quality, efficiency, safety, reactogenicity or the diagnostic product characteristics in vitro and in vivo are researched.
11. During conducting examination the agency gives conclusions about results of registration testing and provisional estimate of the registration file of the State pharmacological commission of veterinary medicine which considers noted conclusions and submits recommendations to the agency about feasibility of the subsequent registration of product.
12. The agency by results of examination prepares expert conclusions in which recommendations of the State pharmacological commission of veterinary medicine are noted, and sends them to the applicant, and also Goskomvetmeditsina together with the copy of the application received according to the procedure, determined in Item 5 of this Provision.
13. Goskomvetmeditsina based on the documents received from the agency makes the decision on registration or refusal in registration of product.
14. Goskomvetmeditsina reports to the applicant about decision making about registration of product along with issue of the registration certificate to it in time which does not exceed 30 days from decision date about registration of product.
The registration certificate is issued addressed to the owner of the registration file for up to five years in the form established Goskomvetmeditsina.
15. After decision making about registration the product joins in the register of veterinary products which conducts Goskomvetmeditsina.
16. The decision on refusal in registration of product is told the applicant with exhaustive explanation of causes of failure.
The decision on refusal in registration can be made in case by results of verification of data and the documents filed by the applicant representation of set of documents of the registration file not in full is revealed or properly quality and safety of product is not confirmed, or there are other indicators noted in Item 3 of this Provision.
The decision on refusal in registration of product is the basis for return to the applicant of the registration file.
Procedure for re-registration of product
17. The re-registration of product is performed as necessary modification of the registration file.
In case of entering into the registration file of changes on type "A" complete examination is not carried out, as "B" - is carried out.
18. For modification of the registration file the applicant submits to the agency corresponding the application and supporting documents and materials in form, the list and according to the procedure which are established Goskomvetmeditsina.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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