Registration of Medicines in the Eurasian Economic Union (EAEU)

After the Decision No. 78 of the Board Eurasian Economic Commission (EEC) on November 3rd, 2016, the “Rules” for registration and expert review of drugs for medical use within the Eurasian Economic Union (EAEU) were approved and entered into force on May 6th, 2017.

The territories of Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan are concerned by this law. From now, all the national marketing authorisations obtained before 31 December 2020, must be compliant to the new rules and the switch has to be done before 31 December 2025.

For any new registration (after 31 December 2020), the new rules will apply. A medicinal product can only be registered through Mutual Recognition Procedure or through Decentralised Procedure. For a Mutual Recognition Procedure, the medicinal product is first registered in a reference member state, then in the states of recognition upon applicant’s request. For a Decentralised procedure, the registration is conducted simultaneously in all the concerned members states.

BlueReg Support

In this context, BlueReg and their local partners can support your company to prepare the switch of the already registered marketing authorisations and / or to prepare any new registration in compliance with the new rules. Thus, BlueReg can help you on:

Project management:

• Plan and track timelines for the preparation and the submission of the switch
• Team Coordination

Regulatory activities:

• Support to module 1 documents preparations (normative document, …)
• Support to strategy submission, including variations strategy if required
• Support to switch
• Support to new registration