Many international manufacturers are unaware of a key regulatory opportunity, such as the option to submit a drug registration dossier in Russia and the EAEU without an EAEU GMP certificate at the initial stage. Instead, you can provide alternative documents (e.g., national GMP or equivalents from FDA/EMA/PMDA) with a commitment to undergo an EAEU GMP inspection during the review or within 3 years after obtaining the registration certificate. Relevant legislation:
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).
Soloreg's expert guidance will help you save time, navigate these options compliantly, and avoid pitfalls. Submit your dossier with us at soloreg.com, secure your registration certificate efficiently, and complete the GMP inspection on your timeline—let's grow your pharma business together!” With SolOReg, you can optimize timelines, reduce regulatory risks, and plan GMP inspections strategically.
