إجراء مقترح من أوكرانيا: المنتجات الصيدلانية

The draft Law proposes to amend the legislation of Ukraine in the field of medicines, including the Laws of Ukraine 'On Medicines' and 'On Administrative Services', in order to establish a new regulatory model while ensuring continuity of relevant state functions and preventing interruptions or undue delays in procedures in the field of medicinal products. The amendments to the Law of Ukraine 'On Medicines', in particular, concern: shortening the overall timeframe for a decision on the state registration (re-registration) of a medicinal product or refusal of such registration (re-registration) from 210 to 180 calendar days; improving the provisions concerning the demonstration of bioequivalence of generic medicinal products; improving the legal framework for clinical trials of medicinal products, including through scientific consultations for applicants on clinical trial-related matters and establishing statutory limits on the cost of the relevant services; expanding the Bolar exemption by allowing the necessary studies, trials, assessments and other activities required for the state registration of a medicinal product, health technology assessment, state price regulation, reimbursement and preparation for participation in public procurement procedures before the expiry of the relevant patent or supplementary protection certificate (SPC), without allowing the placing on the market or commercial use of the respective medicinal product before the expiry of the relevant…