First registrations of drugs under EAEU rules will take place in Kazakhstan

| By | Drug Registration, EAEU, Kazakhstan

The pharmaceutical companies select the Republic of Kazakhstan as the reference country for registration of their products under the common market rules. This was announced by representatives of several pharmaceutical companies at the EAEU and CIS pharmaceutical forum.

The information that Kazakhstan is ready to sign the first contracts was confirmed by representatives of Kazakhstan’s Ministry of Health.

The Ministry of Health of Belarus also expressed its readiness to accept applications as early as tomorrow. Currently, this includes the submission of registration dossier under EAEU rules exclusively in accordance with the mutual recognition procedure.

As for Russia, some companies, that had applied for registration, have seen their applications rejected.

“We prepared the dossier and submitted it in the Russian Federation. After 10 working days, our application was rejected. We were unable to get any detailed explanation of the reasons for rejection. But we are not alone. The applications of other companies were also rejected,” said Andrey Konovalov, Regulatory Affairs Director for Russia and Eurasia at Teva.