Approval of regulations and specifications for new, improved veterinary preparations, feed additives
Free of charge
Within 30 working days
How to get the service in a state agency (required documents):
- Free form application.
- Identity document and document, confirming representative's powers.
- 4 copies of regulations and specification in the official and Russian languages (for foreign applicants- notarized translation into official and Russian languages and copy of regulations and specification with copy of notarized translation) which includes:
- standard of organization and/or international standards;
- instruction for production and control of veterinary preparation, feed additives, signed/approved by the producer of veterinary preparation, feed additives;
- guide (instruction) for use veterinary preparation, feed additives, developed by the producer; \
- passport for master seed and control strains of micro-organisms and for continuos lines (for veterinary preparations);
- document, confirming registration of veterinary preparation, feed additives and/or inclusion into state official pharmacopoeia of the third countries, except for member countries of Customs union and Common Economic Space (if any);
- notarized copy of a contract between producer and patentee of veterinary preparation, feed additives components (strains of micro- organisms, used for production/control of veterinary preparation, feed additives) or for technology/method of veterinary preparation, fee additive production or for its use/appliance;
- report on science and report work in development, modification, improvement of veterinary preparation, feed additive including protocols (acts) of laboratory and production test;
- documents, certifying production of veterinary preparations in accordance with the international standard (Good Manufacturing Practice - good industrial practices) (if any).
Result of the service delivery
Harmonization of normative and technical documentation for new, improved veterinary drugs, feed additives
If the expert opinion is negative, the service provider sends a written refusal to the service recipient in agreeing the normative and technical documentation for new, improved veterinary drugs, feed additives specifying the specific reasons, or a motivated answer about refusal to provide public services