EAEU-level registration opens new possibilities in the single market for medicines.
The first applications under EAEU requirements have been filed. The integrated information system for medicines in the EAEU is under way.
During the transitional period until 2021 both national and EAEU procedures are available for applicants. After the transitional period ends, only medicines registered under the EAEU procedure will be authorised for circulation throughout the whole EAEU market or even on the territory of one member state. Medicines registered under national procedure are only allowed on the territory of that particular member state. To be allowed on the market following the transitional period, all registrations must be aligned with EAEU requirements under a special procedure by the end of 2025.
No single centralised registration is envisaged. Instead, mutual recognition and decentralized procedure are provided for. Both are conducted on the member-state level by authorised governmental bodies.
These procedures are based on corresponding procedures existing in the EU.
Initial registration is valid for 5 years. Subject to confirmation of registration (re-registration) a registration certificate can be issued for an indefinite term.
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