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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 …

Electronic submission of clinical trial applications Date: 14. May 2013 Topics: Licensing Type: News

BfArM and PEI publish a file structure for electronic data carriers (CD-ROM/DVD) for the submission of clinical trial applications for medicinal products.

Section 42b sub-section 2 AMG in conjunction with Section 145 AMG specifies 1 January 2011 as the date of coming into force of Section 42b sub-section 2 AMG. To what does this effective date refer – to the authorisation of the clinical trial, its commencement or its completion? Date: 20. June 2012 Topics: Licensing Type: FAQ

The specification of the deadline '1 January 2011' in Section 42b sub-section 2 AMG in conjunction with Section 145 AMG does not refer to the granting of the authorisation of the clinical trial but to its completion. This means that the …

Are all processing numbers ("Einreichungsnummer", ENR) belonging to the investigational product to be entered in the input box for processing numbers or only those corresponding to the dose strengths that were actually used in the clinical trial? Date: 20. June 2012 Topics: Licensing Type: FAQ

If a report in accordance with Section 42b sub-section 1 AMG is submitted, those ENRs are to be given for which the study was confirmatory for the granting (or change) of marketing authorisation. If a report in accordance with Section 42b …

How is the regulatory situation if the marketing authorisation expires after the study has been completed but before the 1-year publication deadline? Date: 20. June 2012 Topics: Licensing Type: FAQ

Since the medicinal product was licensed at the time the clinical trial was performed, a result report in accordance with Section 42b sub-section 2 AMG is to be submitted.

What are the reporting time-lines for generic medicinal products? Date: 20. June 2012 Topics: Licensing Type: FAQ

The same legal deadlines apply to generic medicinal products as to non-generic medicinal products.

How is it ensured that the result reports published in accordance with Section 42b AMG are not used for circumventing the document protection (against referencing) by manufacturers of generic medicinal products, e.g. by submitting a complete bibliographical application? Date: 20. June 2012 Topics: Licensing Type: FAQ

The publication obligation is legally regulated in Section 42b AMG but it does not affect the document protection pursuant to Section 24b AMG. Section 24b AMG does not constitute protection from publication but merely the protection of the data …

If a clinical trial was performed in order to remove the grounds for the suspension of a marketing authorisation or in connection with possible declarations of voluntary commitment or follow-up measures but did not lead to a change of the marketing authorisation, is it subject to the publication obligation of Section 42b sub-section 1 AMG? Date: 20. June 2012 Topics: Licensing Type: FAQ

If a clinical trial does not lead to (renewal of) a marketing authorisation or a change of an existing marketing authorisation it is not affected by Section 42b sub-section 1 AMG. However, as the clinical trial was performed with a licensed …

Example: After 1 January 2011, a pharmaceutical entrepreneur is granted an extension of indication for a medicinal product that was already licensed before 1 January 2011. Do result reports of the studies supporting this extended indication have to be submitted 6 months after granting thereof even if no trial centre in Germany was concerned? Date: 20. June 2012 Topics: Licensing Type: FAQ

Yes. The legal basis for this is Section 42b sub-section 1 AMG. In contrast to sub-section 2, the provision in sub-section 1 aims at where the medicinal product is placed on the market (scope of the AMG) and not at where the study is performed …