REGISTRATION OF VETERINARY MEDICINAL PRODUCTS
In accordance to requirements of the Regulation “Safety of Veterinary Drugs”, adopted by the Government of the Kyrgyz Republic, medical products intended for animal use must meet the standards of quality, efficacy, and safety of use and must be subject to marketing authorization.
Conformance review of medical products for animal use have following directions:
- marketing authorization;
- National veterinary monitoring;
- Confirming of a rationale for marketing authorization.
Marketing authorization of medical products for animal use is mandatory for companies and individuals engaged in the manufacture, sale, use, as well as import into the country of drugs intended for the prevention, diagnosis, and treatment of animals.
Reg Med Service offers:
1. Preparation of documentation set that needs for registration of veterinary medicinal products:
- submission letter (standard form);
- authorization statement;
- notarized copy of Certificate of Marketing Authorization in a country of origin;
- certificates of compliance and GMP (if granted);
- regulations with according to that quality control is performed;
- analytical reports with results of stability of medical product study;
- standard operating procedure;
- samples of a package;
- a copy of the patent (if present) or certificate of absence of necessity for performing of patent certification checking;
- a copy of the certificate of trademark registration;
2. Interaction with government bodies and representing of client favor.
3. Counseling for considerations associated with marketing authorization procedure
4. Preparing and compilation of registration dossier as well as supporting till acquisition of certificate of marketing authorization
5. Professional translation of documentation
6. Development of leaflet
7. Providing of design service for making of specified package