What is a medicinal product?
According to the Medicines Directive a ‘medicinal product’ is any substance or combination of substances presented for treating or preventing diseases in human beings, or which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings. The Regulation provides a framework clarifying when products containing cells or tissues will be regulated as medicinal products (and as ATMPs in particular). If a product falls within the scope of the Regulation then market authorisation is required to place the ATMP on the market. Market authorisation is granted by the European Medicines Agency (EMEA) – unless the product is exempted. Download definitions of the terms used to define products in ATMP regulation ATMP and the Quality and Safety regulations The HTA and the Medicines and Healthcare products Regulatory Agency (MHRA) have prepared an ATMP Regulation and Quality and Safety Regulations joint sta
