Regulatory Affairs: medicines registration in EAEU

The Eurasian Economic Union (EAEU) consists of Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan. It was formed in 2014 and is headed by the Eurasian Economic Commission (EEC). The EEC has introduced the ‘Agreement on common principles and rules of circulation of medicines within the Eurasian Economic Union’ at the end of 2014, and the ‘Rules of registration and expertise of medicinal products for human use’ (EEC Decision No. 78) on November 3rd, 2016.

The decision describes two pathways of registration, which have become the official procedures from beginning of 2021:

• The mutual recognition procedure, where you file a Market Authorization Application in a member state, and, after approval, you apply for recognition in the other states (duration: 210 calendar days for RMS registration + additional 90 calendar days for recognition);
• The decentralized procedure, where you file an MAA in all (or several) EAEU states simultaneously, choosing one member state as a reference (duration: 210 calendar days).

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Bring into compliance procedure

Medicinal products registered before December 31st, 2020 are required to comply with the new EAEU standards by December 31st, 2025. If the process is not completed, the Marketing Authorizations will ceased to be valid.

The Bring into compliance procedure has a duration of 100 calendar days (excluding clock stops) + 90 calendar days for mutual recognition in the CMS.

If the drug was already registered in at least three member states for five years or more, a registration certificate without an expiration date would be issued. In other cases, the authorities grant the standard validity period of five years.

The process should not include new information on safety, efficacy, or technical details of the medicinal product; any variations should first be submitted for the old national MA.

This procedure has raised many concerns among the pharmaceutical industry since it affects all medicinal products that were previously authorized among EAEU member states according to their national rules.

We aim therefore to raise awareness of the importance of this procedure and seek to provide key strategic considerations for our clients to ensure proper marketing of their medicines in EAEU.

In this context, JSB can support your company to prepare the switch of the already registered marketing authorizations in compliance with the new rules. Thus, JSB can help you on:

1. Analyze your product portfolio.
2. Choose the right Reference Member State.
3. Perform Dossier Gap analysis to assess completeness and quality of existing dossier.
4. Bring the Dossier to EAEU requirements, supporting in the preparation of the Bring into compliance dossier within the set deadlines.