Reissue Registration Certificate proceedings in Ukraine




August 19, 2022

Recently the Order of the MoH of Ukraine No. 1145 of 04.07.2022 "On the approval of the Amendments to the Form of the registration certificate for a medicinal product/medicinal product (immunological medical preparation) and to the Description of the registration certificate for a medicinal product/medicinal product (immunological medical preparation)" has come into force.

According to this order it is necessary to reissue registration certificates for medicinal products that are registered under the special procurement procedure as per the "PROCEDURE verification of the registration materials for their authenticity for a medicinal product that is submitted for the state registration for the purpose of its purchase by a person authorized to carry out purchases in the field of health care, or by a specialized organization" approved by Order of the MoH of Ukraine No. 1391 of 15.06.2020. If a medicinal product has been registered under such procedure, now it is necessary to reissue the registration certificate in order to extend its validity by 01.04.2023. It is impossible to import the medicinal product with the expired registration certificate.

In case you would like us to assist you in the re-issuance of the registration certificate, kindly let us know and we will be glad to provide you with such services.


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