FAQ - Import of Investigational Medicinal Products
No, since 01.01.2006 the shipment notification for the study medication has to be sent to the Federal Office for Safety in Health Care (BASG) in any case. For this purpose, please use the electronic reporting portal to be used since 04.07.2011. According to the Ordinance of the Federal Office for Safety in Health Care on the Electronic Transmission of Applications and Notifications (Electronic Submission Ordinance 2011 - EEVO 2011; published in the Official Gazette of the BASG), applications and notifications under the AWEG have to be submitted in electronic form since 04.07.2011. An electronic portal is available to users under eServices. The use requires prior registration, authorization check and assignment of a user ID. After successful registration, the applicant receives a user name and password for an administration access. The administrator can create and manage users in his own area of responsibility. The handling of the system is described on the BASG website in the Manual on Electronic Applications under the Medicinal Products Import Act 2010.
There is no limit to the size of the clinical requisition (amount of investigational product) and the total anticipated amount can be requested at one time. If it turns out that the quantity of investigational medicinal product in the hospital request was calculated too low, a new hospital request must be created. The calculation and handling of the shipment notification in general is subject to the inspection option. The clinic request does not have to have a specific age. The only thing to note is that the quantities of investigational drug imported or transferred must be fully covered by the clinic requisition and that the clinic requisition must be signed by a physician. The BASG does not require the signature of an institutional pharmacy.
A trial centre only has to fill in form I63 (clinical request for investigational medicinal products) and send it to BASG if an import certificate or a certificate of marketability according to the Medicinal Products Import Act (AWEG) is to be applied for at BASG.
Note: If, in the case of notifications pursuant to AWEG, a clinic request is used more than once, the quantities already shipped at the time of notification must be indicated on it. BASG must be able to trace the quantities already shipped or still to be shipped on the basis of a clinic request.