Ministry of Health Clarified the Procedure of Obtainment of New Registration Certificates for Products with Perpetual Re-registration in Ukraine

Pharmaceutical Regulation

On October 20, 2016, the Ministry of Health of Ukraine published on its official web-site the clarification on the mechanism of exchange of registration certificates for medicinal products being re-registered and therefore their registration became unlimited.

The Ministry provided the following steps for the new document obtainment:

The applicant submits an application in optional form to the State Expert Center with the request to receive new certificate instead of the one that was valid for 5 years.
The State Expert Center prepares the draft registration certificate of the new form and provides it to the applicant for data check and coordination.
The State Expert Center prepares the original document and submits it for MOH signature within 3 working days upon the approval of the draft registration certificate of new form by the applicant.
The applicant receives the new document at the State Expert Center. In order to receive the registration certificate the applicant should provide the power of attorney confirming its authorities.

Please pay your attention to the fact that there is no legislative procedure for application and obtainment of the new registration certificate. In addition, it is worth to mention that the Ministry of Health does not provide the terms for decision making at each stage: the term for the coordination of draft certificate prepared by the State Expert Center, the term for MOH signing the original registration certificate and it’s returning to the State Expert Center.

Moreover, the temporary old registration certificate is valid within the stated terms (5 years), and it may be optionally exchanged by the applicant within the established term.

It is worth to mention that until the changes into the form and description of the registration certificate were approved and the new certificate forms for re-registered and approved for perpetual use medicinal products were ordered, the old registration certificates for the term of 5 years were issued. The analysis of the changes to the form and description of documents that came into effect on 16.09.2016 is available here.