Delivery of IMP to the Trial Site
Delivery of IMP
Based on the Fimea Regulation 1/2007 and 2/2012 (2012 in Finnish only) the investigator may be supplied with investigational medicinal products for a clinical trial by a pharmaceutical manufacturer, an unit manufacturing medicinal products for clinical trials, a wholesale distributor, a hospital pharmacy or a pharmacy operating in Finland. If the trial is conducted at the hospital, the information on investigational medicinal products received directly by the investigator must also be provided to the hospital pharmacy.
The investigational medicinal products are normally delivered to the trial site via the hospital pharmacy or dispensary. It is reguired the hospital pharmacy to provide written instructions for the management, storage and delivery of investigational medicinal products into clinical trials. If pharmacy, hospital pharmacy or medical centre is responsible for the storage of investigational medicinal products, the head of the unit concerned may acknowledge receipt of the investigational products.
If necessary, the investigational medicinal products must be labeled in both official languages of Finland, Finnish and Swedish. If the package is not given to the study subject, the labeling can be in English only.
Repacking and labeling of investigational medicinal products are considered as remanufacturing of medicines which can be done only by a party having the license for the manufacture of investigational medicines, for example, hospital pharmacy. Expiry dates can be amended on justified grounds at the trial site by the sponsor with respective appropriate documentation.
The sponsor must keep a record stating the
delivery, receipt, use, return and destruction of the investigational
medicinal product. The investigator is responsible for the records of
medicinal products at the trial site but usually in cooperation with the