إجراء مقترح من أوكرانيا: الأدوية واللقاحات

The Order has been adopted to align regulatory acts with the Law of Ukraine No. 4239-IX of 12 February 2025 'On Amendments to Certain Laws of Ukraine Regarding the Peculiarities of State Registration of Medicines That Can Be Purchased by an Entity Authorized to Carry Out Procurement in the Healthcare Sector and on the Regulation of Certain Issues Related to the Sale of Medicines'. The Order, in particular, amends the Procedure for Termination of Registration Certificate for a Medicine, approved by the Order of the Ministry of Health No. 1801 of 5 August 2020. The amendments clarify that the Ministry of Health may decide to impose a full or temporary restriction on the use of a medicine by terminating its registration certificate without reimbursement of the state registration fee. This applies where the results of the examination and/or review of the registration materials submitted with an application for state registration, re-registration or amendment of the registration materials for a medicine confirm that any stage of the production process, including development or clinical investigations (if initiated after the introduction of martial law in Ukraine), is carried out by enterprises whose production facilities are located in the territory of the Russian Federation or the Republic of Belarus.