Regulatory Competence for Russian Federation and CIS
New registration and maintenance of registrations of medicinal productsand medical devices
The legislation for registration of medicinal products in Russian Federation and CIS countries is very complex and subject to permanent changes.
Furthermore, the recently implemented roles for registration and circulation of medicinal drug products in EAEU (Eurasian Economic Union) are partly in development, others to be changed as to lack of experiences. .EAEU legislations have strong impact on the national legislations of the EAEU member state and are sometime controversy to national requirements
GxP roles must be followed strictly. GMP inspections of foreign manufacturing sites conducted by the national and regional authorities are requested more and more.
Until 2025 all national registrations for medicinal products in EAEU member states have to be updated (so called “upgrade” or “bringing into compliance with EAEU standards” procedure).
We will guide you through the jungle of national, regional and international legislations. We aim to define together with you a successful registration strategy for your medicinal product.
In cooperation with hand-picked local partners, we offer services for registration and maintenance of medicinal products, food supplements and APIs.
Registration of medical devices
The registration rolesfor Medical Devices in Russian Federation and CIS countries are not very transparent and far away from harmonisation. The implementation of EAEU roles is under discussions.
Please contact us in case you wish to register your medical device in Russian Federation or CIS countries.
GMP Inspections by Russian and EAEU authorities
Successful GMP inspections of foreign manufacturing sites by Russian authorities are pre condition for any new registration of medicinal products in Russian Federation as well as for special variations. .
The EAEU Eurasian Economic Union does also request GMP certificates for new submissions. upgrade procedures as well.
We support you in applications for GMP inspections, preparations to GMP inspection and, of course, during the GMP inspections either.
Since COVID-19 pandemic the Russian legislation does officially allow the conduct of remote GMP inspections. We support you in such inspections.
Local Bioequivalence studies
The conduct of a local bioequivalence study is much more than a repetition of the European BE study under Russian conditions.
Many factors have to be considered for a successful BE study conduct:
- Who is the right partner offering services on high level of GCP quality?
- What is the reference product accepted for registration process?
- How to organize import of study medication and export of samples?
- How to monitor the study conduct?
We offer you services in selecting the best local partner you can trust and take over sub parts of BE Study conducting.
Due diligence of dossiers
You want to licence in a local product into your local or international portfolio?
We will check the dossier and find answers to the question if the dossier is eligible for registration, or in case the product is already marketed which work load to be expected in future to maintain the registration.