Two parallel systems
Registration in the region follows either the harmonised Eurasian Economic Union (EAEU) procedure – covering Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan – or national procedures in countries such as Uzbekistan, Tajikistan, Azerbaijan, Georgia, Turkmenistan and Moldova. Choosing the right route depends on your target markets and dossier readiness.
Dossier requirements
- CTD-format dossier with regional Module 1 (EAEU) or national administrative documents
- GMP certificate recognised by the authority; EAEU GMP inspection may be required
- Certificate of pharmaceutical product (CPP) and free-sale certificate, legalised
- Russian-language (and often local-language) SmPC, leaflet and labelling
- Samples and reference standards for laboratory testing
- Stability data covering the climatic zone of the market
Timelines and costs
National procedures typically take six to eighteen months depending on the country, the completeness of the dossier and the need for laboratory testing or inspection. The EAEU procedure provides mutual recognition between member states but requires EAEU-compliant documentation and may involve a GMP inspection by a member-state inspectorate.
Practical advice
- Start with a regulatory gap analysis of your existing dossier
- Plan legalisation of documents early – it is a frequent cause of delay
- Budget for translation and for local-language artwork
- Appoint an experienced local representative or partner
- Keep pharmacovigilance obligations in view from the day of approval
Unimax Pharm supports manufacturers with registration strategy, dossier adaptation and coordination with local partners across the CIS and Central Asia.