Manufacture and Import of IMP
Manufacture of IMP
According to the Medicines Act (395/1987) medicinal products including investigational medicinal products are licensed to be manufactured by the permission of Fimea in a pharmaceutical manufacturing plant, in a unit manufacturing medicinal products for clinical trials, in a pharmacy, in a subsidiary pharmacy, in a hospital pharmacy or dispensary. Hospital pharmacies and dispensaries are allowed to manufacture medicinal products only for the hospital’s or health center’s own use. If the manufacturer is a pharmaceutical company its respective authorization needs to cover the pharmaceutical form of the product used in the trial. Investigational medicinal products must be manufactured in accordance with the principles on Good Manufacturing Practice (GMP), adhering to Good Clinical Practice related to Investigational Medicinal Products for Human use implemented in the EU, and observing respective detailed guidance, and requirements related to the manufacturing authorization or import license of the products concerned.
Import of IMP
Investigational medicinal products can be imported by parties that are licensed to manufacture medicinal products for clinical trials and to practice medicinal product wholesale according to their license, for example pharmaceutical companies, medicinal product wholesalers, pharmacies, and units manufacturing medicinal products for clinical trials including universities. In addition, it is to be taken into account that pharmacies, hospital pharmacies and medicinal product wholesalers can import only investigational medicinal products already released in the EU/EEA. Their manufacture and release is subject to a manufacturing authorization granted by the competent supervisory authority for medicines. A corresponding authorisation is also required of the importer of investigational medicinal products manufactured outside the EU/EEA. Please note! An individual investigator is not allowed to import investigational medicinal products for clinical trials.