Registration of veterinary medicinal products and feed additives
The organization of research, collecting documents, monitoring of the registration process
According to Federal Law of April 12, 2010 № 61-FZ “On circulation of medicinal products” a prerequisite for adoption of medicines and feed additives for veterinary use is their state registration. In accordance with the order of Ministry of Agriculture of the Russian Federation of April 1, 2005 N 48 “On approval of rules of state registration of medicines for animals and feed additives” the following shall be subject to mandatory registration:
- the original medicinal products;
- the original additives;
- new combinations of previously registered medicines;
- new combinations of previously registered additives;
- previously registered medicinal products, but produced in other dosage forms, or with the new dosage, or with a different set of excipients;
- supplements, registered earlier, but produced in other forms, or with the new dosage, or with a different composition of the excipients;
- reproduced medicinal products;
- reproduced additives.
Receiving the state registration certificate is a long multistep process that requires knowledge of both the legal and regulatory framework and methodological framework for evaluating the efficacy and safety of medicines and feed additives.
Services of our company in the registration of veterinary medicinal products and feed additives:
- Registration of generic medicinal products;
- Registration of innovative medicines (MP);
- Confirmation of registration of MP in connection with the expiration of the state registration;
- Amendments to the regulatory documentation;
- Completion of the registration process from any stage;
- Registration of feed additives;
- Formation of a request to the Federal Service for Veterinary and Phytosanitary Supervision (Rosselkhoznadzor);
- Preliminary expertise of the registration dossier;
- Preparation of registration dossier;
- Organization and maintenance of preclinical studies;
- Organization and maintenance of clinical studies;
- Organization and maintenance of bioequivalence studies;
- Drafting of instruction;
- Development of regulatory documents;
- Preparation of the package layouts.
Our employees will help to carry out properly and fully preclinical and clinical studies, bioequivalence studies, to draw up normative documents and complement the registration dossier. Monitoring of each phase of registration, starting from studies to the inclusion of the medicinal product to the National Register of medicinal products, enables to achieve maximum quality of services provided and conducting the expertise and obtaining a registration certificate in a timely manner.