إجراء مقترح من أوكرانيا: المنتجات الصيدلانية

The draft Order has been developed in accordance with the Law of Ukraine No. 2469-IX of 28 July 2022 'On Medicines', which provides for the establishment and operation of a single regulatory authority responsible for state control in the field of the circulation of medicines. The draft Order aims to clarify the procedure governing the parallel import of medicines following the establishment of a central executive authority with special status responsible for implementing state policy in the areas of the development, market authorization, quality control, safety, and efficacy of medicines. The regulatory authority established for this purpose is the Ukrainian Pharmaceutical Agency (Ukrpharmagency). The parallel import of medicines may be carried out by a business entity holding a licence to import medicines (a parallel importer), in accordance with the licensing conditions established by the Cabinet of Ministers of Ukraine, only after the Ukrainian Pharmaceutical Agency has granted the business entity a parallel import permit. Accordingly, the draft Order transfers the functions relating to the issuance, amendment, suspension, сancelling and termination of parallel import permits from the State Service of Ukraine on Medicines and Drugs Control and the State Enterprise 'State Expert Center of the Ministry of Health of Ukraine' to the Ukrainian Pharmaceutical Agency.