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Since 4 August 2013, the BfArM neither requires paper submissions nor digital signatures. However, the application form for variations states that the main signatory is mandatory. Likewise, the form for purely national variations provided via the PharmNet.Bund portal requires a signature. Does this mean, that these forms have to be printed, signed and submitted as a scanned document? Date: 23. September 2013 Topics: Licensing Type: FAQ

Provided the submission is made via the PharmNet.Bund and/or CESP portals, no signature is necessary on these forms. The authorisation procedure and the login data needed for this purpose which are part of the PharmNet.Bund and/or CESP portals …

Is it possible to use marketed (licensed) medicinal products in the usual market packaging and labelling as study medication without study-specific relabelling? Date: 23. September 2013 Topics: Licensing Type: FAQ

Yes, if this is in agreement with the study design.

Exception: If the channel of distribution (wholesale, pharmacy) is not maintained, an additional label bearing the information “for clinical trial use only” is required (Section 47 sub-section 1 …

Is the repackaging and relabelling of a licensed medicinal product a manufacturing step? Date: 23. September 2013 Topics: Licensing Type: FAQ

Yes, it is. The manufacturer who releases a modified drug product after such a manufacturing step has to be stated under D.8.2 in the application form.

Which kind of accompanying document can contain relevant labelling information omitted in the labelling? Date: 23. September 2013 Topics: Licensing Type: FAQ

An accompanying document can be a patient information leaflet or card which is handed out to the subject together with the investigational medicinal product.

The document must not be submitted to the Federal Institute for Drugs and Medical Devices (

Does the labelling of the IMPs have to be in German language? Date: 23. September 2013 Topics: Licensing Type: FAQ

Yes, labelling in German language is necessary. This labelling must comply with the requirements of Section 5 of the GCP Ordinance.

If the BfArM's Fee Ordinance is not applicable for new variations on purely national licences, how can I calculate the relevant fees or rather how will the invoices be prepared? Date: 02. August 2013 Topics: Licensing Type: FAQ

For processing purely national variations there will first be a conditional fee, i.e. the BfArM explicitly reserves the right to request fees after an amendment of the AMG Fees Ordinance. The exact amount of the fees will be determined by the …

Is there also a status "in process" for Type IA notifications? Date: 02. August 2013 Topics: Licensing Type: FAQ

As Type IA notifications are simple validation procedures, the procedure will normally be completed directly after validation so that no "in process" phase will exist.

How shall texts be submitted after the end of the procedure?
Date: 02. August 2013 Topics: Licensing Type: FAQ

In cases where variation applications also lead to changes in the product information (Package Leaflet and SmPC), the amended version of these texts has to be submitted immediately to the relevant national competent authority in accordance with …

In July 2013, many CMS variations received the status "End of procedure"; the final product information, however, is not yet published. Is this situation due to the amended regulation? Date: 02. August 2013 Topics: Licensing Type: FAQ

Due to the newly created link between the AMIS database with adjoining IT systems, data were automatically transferred into AMIS. This transfer triggered the status information. However, the formal closure of these procedures still has to be …

Do I need to consider any special recommendations for sending an "electronic-only" submissions? Date: 25. July 2013 Topics: Licensing Type: FAQ

Prior to filing an application, an informal letter should be sent, either by telefax to Bundesinstitut für Arzneimittel und Medizinprodukte, Fachregistratur Z14.1, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn - telefax number: +49 228 207 3681 or by …