FAQ - Import of Investigational Medicinal Products

Does a start date of a clinical trial prior to 01.01.2006 affect the recipient of the import notification?

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.

Imports of medicinal products were reported to the Federal Ministry of Health and Women's Affairs in the context of a clinical trial that has been running since 2005. To whom should imports for the same study be reported as of 01.01.2006?

Also in the case of clinical studies that started before 01.01.2006, shipment notifications must be submitted to the Federal Office for Safety in Health Care (BASG) as of 01.01.2006, even if import notifications were already submitted to the Federal Ministry in 2005 in the course of this study.

Is there a limit to the size of the clinic requisition, or can the total amount likely to be needed be estimated at the start of a study and entered in the clinic requisition?

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.

Does an investigational site always have to fill in form I63 "Clinical requisition for investigational medicinal products" ?

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.

Is the form F_INS_VIE_00QM_I63 "Clinical Requisition for Investigational Medicinal Products" sufficient as an application for an import authorisation?

No. This form is not the sole basis for an attachment. It merely proves that the entire quantity of investigational medicinal products moved across the federal border is covered by a physician's requisition and fulfils the purpose of Section 5(4) AWEG.

The form F_INS_VIE_00QM_I63 "Clinical requisition for investigational medicinal products" requires the "Head of Clinical Department" to sign it. Does this mean the clinical department at the trial site?

yes

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