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Member companies of the European Business Association’s Health Care Committee held their regular quarterly meeting with Roman Isaienko, Head of the State Service of Ukraine on Medicines and Drugs Control. During the event, participants addressed critical issues related to the regulation of medicines circulation in Ukraine, including the simultaneous validity of two marketing authorisations, the recognition of European GMP certificates in Ukraine, and the application of Braille on medicine packaging.<\/p>\n
One of the key topics was the issue of state control in cases where two marketing authorisations for the same medicinal product are valid simultaneously, a concern frequently raised by companies with the Committee in recent months. Despite no legislative changes regarding this matter, the business community is worried about shifts in the approach to state control of such medicines. The Head of the State Service promised to review these cases and investigate the legality of blocking medicines during state inspections under one of the marketing authorisations.<\/p>\n
Another significant discussion focused on the draft procedure for GMP compliance developed in response to the new Law of Ukraine “On Medicines.” According to the business community, the proposed procedure is inconsistent with the general principles of Ukraine’s European integration process and misaligns Ukrainian legislation with EU regulatory acts. As the EU does not require an additional recognition procedure for GMP certificates, Ukraine should align its legislation with this standard.<\/p>\n
Special attention was given to the issue of applying Braille on secondary medicine packaging. The Committee Manager noted that this matter had been discussed with the Head of the Service previously; however, companies continue to receive remarks from State Service experts. The business community expressed hope that recommendations regarding Braille application would soon be legislatively formalised, ensuring clear and transparent requirements for all market participants.<\/p>\n
The practice of quarterly meetings fosters open dialogue between the State Service and the Committee, and we hope it will continue on a regular basis.<\/p>\n
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Member companies of the European Business Association’s Health Care Committee held their regular quarterly meeting with Roman Isaienko, Head of the State Service of Ukraine on Medicines and Drugs Control. During the event, participants addressed critical issues related to the regulation of medicines circulation in Ukraine, including the simultaneous validity of two marketing authorisations, the […]<\/p>\n","protected":false},"author":33544,"featured_media":605235,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n