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Announcement on the notification of variations for purely national licences in accordance with Chapter IIa of Regulation (EC) 1234/2008 as of 4 August 2013 which are within the BfArM's responsibility in accordance wtih Section 77 AMG PDF, 283KB, File does not meet accessibility standards Date: 12. July 2013 Topics: Licensing Type: Announcement

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.

Placing medicinal products with duplicate marketing authorisations but different marketing authorisation holders on the market: In the case of different legal persons, can one marketing authorisation holder also enter the processing number ("Einreichungs¬nummer", ENR) of another marketing authorisation holder's duplicate marketing authorisation in the web portal when submitting his report and does this mean that the other marketing authorisation holder's obligation ceases? Date: 20. June 2012 Topics: Licensing Type: FAQ

As a rule, a pharmaceutical entrepreneur can mandate another pharmaceutical entrepreneur to make a submission via the web portal. However, in the case of duplicate or "informed consent" marketing authorisations no report is necessary as these …

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 …