Registration of veterinary products and feed supplements. Organization of research, collection of documents, monitoring of registration progress
Pursuant to the Federal law of RF dated April 12, 2010 No.61-FZ “On Circulation of Medicines”, the prerequisite for issuance of medicines and feed supplements for veterinary application is the related state registration. According to the Order of RF Ministry of Agriculture dated April 1, 2005 No.48 “On approving the Rules for state registration of medicines for animal and feed supplements” the following elements are subject to mandatory registration:
- original medicines;
- original supplements;
- new combinations of previously registered medicines;
- new combinations of previously registered supplements;
- medicines registered earlier, but manufactured in other dosage forms or with new dosage or with other composition of auxiliary substances;
- supplements registered earlier but manufactured in other forms or with new dosage or with other composition of auxiliary substances;
- reproduced medicines;
- reproduced supplements.
The obtaining of the state registration certificate is a long-term multi-level process requiring awareness of the regulatory legal framework as well as methodological basis on assessment of efficacy and safety of medicines and feed supplements.
The services of our company in the area of registration of veterinary products and feed supplements:
- Registration of generics;
- Registration of innovative medicines;
- Confirmation of registration of medicines due to expiry date of state registration;
- Introduction of amendments into the regulatory documentation;
- Completion of the registration process at any stage;
- Registration of feed supplements;
Additional services:
- Drafting a request to the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor);
- Preliminary expertise of a registration dossier;
- Preparation of a registration dossier;
- Organization and support of preclinical research;
- Organization and support of clinical research;
- Organization and support of bioequivalence research;
- Drafting guidelines;
- Development of regulatory documentation;
- Preparation of packaging layouts;
The employees from our company will assist in organizing the process of preclinical and clinical research, bioequivalence research in a competent and full manner, drafting regulatory documents and complementing the registration dossier. The monitoring of each stage of registration starting with research and ending with entering the medicine into the State register of medicines enables to attain the best quality of the services provided and conduct expertise and obtain a registration dossier within the set time frame.