New Regulatory Reality & Market Opportunities
EAEU Registration:
Start Without a EAEU GMP Certificate
Tilda Publishing
Many international manufacturers overlook a key regulatory opportunity that can significantly speed up market access in Russia and the EAEU.
The Key Advantage: You can submit a new drug registration dossier without holding a valid EAEU GMP certificate at the time of submission.
How Does This Opportunity Work?

Instead of an EAEU GMP certificate, applicants can provide:
  1. Alternative Supporting Documents (e.g., national GMP certificates from EAEU member states, or equivalents from stringent authorities like the FDA, EMA, or PMDA).
  2. A Written Commitment to organize and undergo an EAEU GMP inspection within a set timeframe.

Important:
 The inspection is scheduled during the expert evaluation phase and
 must be successfully completed before the registration process is finalized.

Legal Basis:
Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016 "On the Rules for Registration and Expertise of Medicinal Products for Medical Use" (as amended by Decision No. 34 dated May 22, 2025).
Full text available at the EEC website: docs.eaeunion.org
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How Soloreg Helps You Leverage This Window of Opportunity

To let you focus on growing your business, Soloreg manages the regulatory process and turns this complex procedure into a clear, actionable plan.

Step

How Soloreg Helps

1. Preparing the Alternative Package

We will review your current certificates (FDA, EMA, etc.) for compliance with EAEU requirements and draft the legally sound written commitment to undergo the inspection.

2. Dossier Submission

We initiate the registration process, leveraging this regulatory flexibility. You start the expert evaluation without delays caused by waiting for an inspection.

3. Managing the GMP Inspection

We help schedule the inspection at the most convenient time for you. This allows you to receive queries from the experts first, ensure there are no critical remarks on the product, and only then proceed with the final stage of the production site audit.

4. Finalizing Registration

We guide you through to the issuance of your registration certificate, ensuring all steps are completed on time and without compliance breaches.


Why This Approach Benefits Your Business

This strategy is ideal for an aggressive and fast-track entry into the Russian and EAEU markets.
✅ Save Time. Prepare and submit your dossier in parallel with your internal preparation for the inspection, rather than waiting for it to be completed first.
✅ Reduce Risk. This scheme allows you to "hedge your bets." The inspection is deferred to the end of the process. By then, you will have received feedback from the pharmaceutical expertise and can proceed with the inspection, confident that the dossier is solid.
✅ Flexible Planning. You can undergo the GMP inspection after addressing the main regulatory queries, allowing for better resource allocation within your team.
Ready to Get Started?
Trust Soloreg's expert guidance. We help you navigate these options compliantly, save time, and avoid common pitfalls.
📌 Submit your dossier with us at soloreg.com to secure your registration certificate efficiently and complete the GMP inspection on your timeline.
Let's grow your pharma business together with Soloreg!
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