إجراء مقترح من أوكرانيا: المنتجات الصيدلانية

The draft Order has been developed in accordance with the requirements of Articles 47 and 108 of the Law of Ukraine 'On Medicines' No. 2469-IX of 28 July 2022, taking into account relevant European Union legislation. In accordance with Article 47(4) of the Law, confirmation of compliance of medicine manufacturing with the Good Manufacturing Practice requirements established in Ukraine, including for manufacturing facilities located outside Ukraine, shall be carried out by the state control authority through the inspection of manufacturing facilities conducted in a manner aligned with European Union legislation, taking into account the inspection procedures and information exchange practices applied in the European Union for the manufacture and distribution of medicines, and based on a risk-based planning approach (except for imported active pharmaceutical ingredients). The draft Order establishes the legal and organisational framework for the procedure for confirming compliance of manufacturing conditions of medicines at manufacturing facilities located outside Ukraine with the Good Manufacturing Practice (GMP) requirements established in Ukraine. In particular, it provides for: the inspection of medicine manufacturing facilities located outside Ukraine; the recognition of official GMP compliance documents issued by competent authorities of countries with Stringent Regulatory Authorities (SRAs); the issuance by the state control authority of documents confirming GMP…