The pharmaceutical business community is concerned about the need to re-register medicinal products registered under the procedure for medicinal products registered by the competent authorities of the United States of America, the Swiss Confederation, Japan, Australia, Canada, the EU (centralized procedure), according to the order of the Ministry of Health of Ukraine (hereinafter - Ministry of Health) No. 1245 of November 17, 2016 (hereinafter - medicinal products registered under procedure 1245).
Please note that in the new version of the Law of Ukraine No. 2469-IX dated July 28, 2022 "On Medicinal Products" in the transitional provisions it is stated that the registration certificate for a medicinal product, which was issued before the entry into force of the new Law "On Medicinal Products" and has a limited validity period, is valid for the period specified in this certificate.
The law also provides that for the purpose of re-registration of a medicinal product, the owner of the registration shall submit a corresponding application to the state control body no later than nine months before the expiration of the state registration.
The need for re-registration can have a negative impact on patient access to critical and innovative medicines and vaccines.
Since the Law does not establish a requirement for the re-registration of already registered medicinal products, we should expect clarification on the need for re-registration of medicinal products registered under the 1245 procedure, and also, it would not be superfluous to develop and approve a mechanism according to which the materials of the registration dossier for medicinal products registered under procedure 1245, are brought into compliance with the new requirements of the Law of Ukraine "On Medicinal Products" No. 1245 of November 17, 2016 during the re-registration procedure in a planned manner and without the need for re-registration.
