As Ukraine transitions to MDR and IVDR, the government aims to use European electronic systems rather than developing its own. This approach seems reasonable, but is it feasible? One of the key innovations of MDR and IVDR is the Unique Device Identification (UDI) system and the EUDAMED electronic database. In Ukraine, the regulation of medical […]
Changes in procedure of state registration of medicines, Ukraine
On April 9, 2019, the Resolution of the Cabinet of Ministers of Ukraine No. 296 came into force and approved amendments to the Resolution of the Cabinet of Ministers of Ukraine No. 376 of May 26, 2005 “On approval of the procedure for state registration (reregistration) of medicines and fees for their state registration (reregistration)” and to the Order of the MoH of Ukraine No. 358 of August 29, 2003 “On approval of the form and description of the registration certificate for a medicinal product”.
These changes define that the Application for re-registration (renewal of registration) of a medicinal product shall be submitted not earlier than one year, but not later than 180 calendar days before the expiry of the registration certificate. Submission of the Application after defined deadline will lead to new registration procedure.
We remind you that previous deadline for submission of the renewal Application was 90 days.
The above-mentioned amendments to the Resolution of the Cabinet of Ministers of Ukraine No.376 have also extended until March 31, 2020 the validity of certificates for medicinal products registered in accordance with the Order of the Ministry of Health of Ukraine No. 721 of 03.11.2015 “On Approval of the Procedure for Examination of the Authenticity of Registration Materials on Medicinal Product state registration for the purpose of its procurement by a specialized organization. ”
State Register of Medicines of Ukraine has been already amended with updated certificates: http://www.drlz.com.ua/
MAH or it’s representative should submit the letter to the State Exert Center of MoH and pay the Invoice app. 20 EURO to obtain original extended certificate.
We remind you that the Law of Ukraine “On the State Budget of Ukraine for 2019” introduced amendments to the relevant legal acts and extended procurement with the involvement of specialized organizations for another year.
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