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ORDER OF THE MINISTER OF AGRICULTURE OF THE REPUBLIC OF KAZAKHSTAN

of November 24, 2014 No. 7-1/611

About approval of Rules of carrying out approbation of veterinary medicine and feed additives

(as amended on 16-09-2015)

According to subitem 46-20) of article 8 of the Law of the Republic of Kazakhstan on July 10, 2002 "About veterinary science", PRIKAZYVAYU:

1. Approve the enclosed Rules of carrying out approbation of veterinary medicine and feed additives.

2. To provide to department of veterinary and food safety of the Ministry of Agriculture of the Republic of Kazakhstan in the procedure established by the legislation the state registration of this order in the Ministry of Justice of the Republic of Kazakhstan and its official publication.

3. To impose control of execution of this order on the supervising vice-Minister of Agriculture of the Republic of Kazakhstan.

4. This order becomes effective after ten calendar days after day of its first official publication.

Minister

A. Mamytbekov

It is approved

Minister of national economy of the Republic of Kazakhstan

January 19, 2014

 

E.Dosayev

It is approved

Minister of investments and development of the Republic of Kazakhstan

December 15, 2014

 

A. Isekeshev

Approved by the Order of the Minister of Agriculture of the Republic of Kazakhstan of November 24, 2014 No. 7-1/611

Rules of carrying out approbation of veterinary medicine and feed additives

1. General provisions

1. These rules of carrying out approbation of veterinary medicine and feed additives (further - Rules) are developed according to subitem 46-20) of article 8 of the Law of the Republic of Kazakhstan of July 10, 2002 "About veterinary science" and determine procedure for approbation of veterinary medicine, feed additives in the territory of the Republic of Kazakhstan.

2. In Rules the following concepts are used:

1) department of authorized body in the field of veterinary science (further - department) - the division of authorized body in the field of veterinary science exercising the state veterinary health control and supervision;

2) new veterinary medicine, feed additive - veterinary medicine (the medicine used (applied) in veterinary science), feed additive which in member countries of the Customs union and Eurasian Economic Space were not made earlier were not imported and not applied;

3) advanced veterinary medicine, feed additive - the veterinary medicine (the medicine used (applied) in veterinary science), the feed additive registered earlier, but made in other dosage forms and/or with new dosage, and/or other composition of excipients (components) and also with change(s) of the production technology which affected its properties and quality characteristics, different ways of its use (application, storage) or the indication to use (applications, storages);

4) the applicant - the physical person or legal entity which submitted the application for approbation of veterinary medicine, feed additives;

5) pharmacopeia - the collection of the standards and provisions normalizing quality of medicinal substances.

3. Approbations are subject developed or advanced veterinary medicines, feed additives, including developed or advanced as a result of scientific research.

The veterinary medicines, feed additives registered and applied in other states or brought in the state pharmacopeia of other countries are not subject to approbation.

2. Procedure for carrying out approbation of veterinary medicine and feed additives

4. The applicant directs to department the application on carrying out approbation of veterinary medicine, feed additives in form, according to appendix to these rules.

5. The notarized copy of the specifications and technical documentation coordinated with department on new, advanced veterinary medicines, feed additives (further - the specifications and technical documentation) in the state and Russian languages is enclosed to the application.

6. Department considers the application within five working days and sends to the specifications and technical documentation to the state veterinary organization performing function on carrying out approbation of veterinary medicines, feed additives (further - the veterinary organization).

In case of submission of not approved specifications and technical documentation the application is returned to the applicant without consideration within three working days with indication of the reasons.

7. The veterinary organization within ten calendar days after receipt of the specifications and technical documentation constitutes and sends to Department the draft of the Program of carrying out approbation of veterinary medicine, feed additive in any form (further - the Program).

8. Department within seven working days from the date of receipt of the project Programs are adopted by one of the following decisions:

1) is approved by the draft of the Program and issues the order on the organization of carrying out approbation of veterinary medicine, feed additives to which the Program and structure of the commission for carrying out approbation of veterinary medicine, feed additives affirms (further - the Commission);

2) is not approved by the draft of the Program of approbation and directs the written answer with indication of specific notes and offers.

In case of not approval of the draft of the Program the veterinary organization resolves comments and repeatedly within five working days brings it in Department.

9. Are part of the Commission:

1) the specialist of Department - the commission chairman;

2) chief state veterinary health inspector of the corresponding administrative and territorial unit, vice-chairman of the Commission;

3) specialist(s) of the veterinary organization;

4) scientist of the corresponding profile;

5) the head(s) of the business entities participating in carrying out approbation of veterinary medicine, feed additive;

6) applicant (physical person, or representative of the legal entity).

10. The venue of approbation of veterinary medicine, feed additives is determined by Department taking into account the Program.

11. The organization and carrying out approbation of veterinary medicine, feed additives are performed by the veterinary organization which also provides participation and acquaintance with the Program of all members of the commission.

12. For carrying out approbation of veterinary medicine, feed additives the Applicant provides delivery of veterinary medicine, feed additives in the amount specified in the Program to the venue of approbation.

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