To enter pharmaceutical market, state registration is mandatory for veterinary drugs.
RDG Services:
- Preparation of proposals for the registration of the drug (calculations on the duration, cost of the procedure, the necessity for studies)
- Representation in the course of paperwork (without transfer of rights to possession and the use of registration, etc.)
- Conduct of preclinical study
- Development of normative documentation
- Preliminary expertise of registration dossier
- Preparation of registration dossier
- Organization and support of clinical studies and bioequivalence studies
- Preparation of instruction
- Preparation of layout package
- Preparation of reports for safety monitoring
Subjects to mandatory registration:
- original drugs
- original supplements
- new combinations of previously registered drugs
- new combinations of previously registered supplements
- medicines that were registered earlier but are now produced in other dosage forms, or with new dosage, or with different set of excipients
- supplements that were registered earlier but are now produced in other dosage forms, or with new dosage, or with different set of excipients
- generic drugs
- generic supplements
Registration dossier includes full set of documents.
Stages of registration of veterinary drugs:
- Conduct of preclinical and clinical studies
- Submission of registration dossier to Rosselkhoznadzor (Federal Veterinary And Phytosanitary Surveillance)
- Examination of documents from All-Russian State Centre for Quality and Standardization of Veterinary Drugs and Feed (VGNKI)
- Issue of Marketing authorization
The duration of registration procedure is approximately 6 months.
The cost of registration of veterinary drugs includes the following costs:
- State tax
- RDG services on registration
- Costs of preclinical studies
- Import of drugs
- Translation of documentation