As determined in Article 83 of Decree 726/2004/EC, compassionate use means provision of a medicinal product with a new active ingredient which represents an important therapeutic, scientific, and technical innovation, and must be undergoing clinical trial or have entered the centralised marketing-authorisation application process, whereby it is made available to a group of patients with chronically or seriously debilitating disease which cannot be treated satisfactorily by an authorised medicinal product.
The applicant prepares the application for obtaining a licence for compassionate use of the medicinal product in accordance with Article 41 of ZZdr-2.
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
