The manufacture/import and marketing of medicinal products and medical devices is heavily regulated in Russia, with a number of different entities involved in the regulatory procedures. Although the registration process for medical devices is relatively straightforward, the registration process for drugs covers five key areas: original drugs, generic drugs, new combinations of previously approved drugs for medical use; previously approved drugs for medical use in new dosage form(s) or a new dosage; and orphan drugs. The registration process in all five areas is complex and lengthy and requires very careful planning and management if time delays and/or unnecessary associated costs are to be avoided.
Further regulatory change is inevitable, particularly given Russia’s membership of the Eurasian Economic Union. Navigating the system is not without its pitfalls and understanding the key regulatory players, structures and systems in what continues to be an evolving regulatory situation is vital to building a sustainable business in the country.
As your local regulatory partner Grove has access to the key institutions regulating the Russian market, notably, the Ministry of Healthcare of the Russian Federation (MINZDRAV) and within this, Federal Service for Surveillance in Healthcare (Roszdravnadzor) for issues related to drug safety, pharmacovigilance and distribution.
Grove provides regulatory consulting services in Russia in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.
REGULATORY AFFAIRS CONSULTING SERVICES IN RUSSIA – PRE-SUBMISSION AND SUBMISSION ACTIVITIES
With their comprehensive understanding of local regulatory requirements, Grove’s regulatory affairs consultants work closely with their clients through the necessary pre-submission and submission activities required. Key within this is:
- Regulatory consulting – regulatory submissions and registration related services
- Preparation and submission of relevant documentation for drug registration and marketing authorization
- Medical device registration
- Liaison with local agencies to monitor progress
- Assistance with packaging/labelling approval (packaging material submissions, labelling compliance/approval)
- Readability testing for local language Patient Information Leaflets
REGULATORY SERVICES IN RUSSIA – MAINTENANCE OF REGULATORY APPROVAL/MA
Grove’s in-country regulatory affairs team provides a full support service post-submission, and work with clients in the following areas:
- Post-marketing applications
- Marketing authorization transfer services
- Support for the management of national Agency databases
- Submission of annual specific national declarations
- Packaging/labelling compliance
REGULATORY CONSULTING – MONITORING OF LOCAL REGULATORY REQUIREMENTS
Completing the full-service regulatory package that Grove’s regulatory affairs consulting team provide, Grove will:
- Monitor local regulatory change and provide appropriate updates
- Assess national regulatory documentation and provide appropriate updates
- Ensure compliance with Russian regulatory requirements given any change in national legislation, regulations and policies
- Provide relevant safety updates
Key product areas covered:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Food and dietary supplements