BfArM - Federal Institute for Drugs and Medical Devices

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D.1. Does the obligation to notify the national competent authority also apply to registered medicinal products? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, in accordance with Section 39 sub-section 2c sentence 2 AMG, Section 31 AMG also applies correspondingly to the expiry of registrations.

F.1. Are notifications in accordance with Section 29 sub-sections 1b, 1c AMG subject to fees? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, in accordance with the currently valid Fees Ordinance (Besondere Gebührenverordnung BMG (BMGBGebV)) such notifications are subject to fees.

F.2. Are applications for exemptions pursuant to Section 31 sub-section 1 sentence 2 AMG subject to fees? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, in accordance with the currently valid Fees Ordinance (Besondere Gebührenverordnung BMG (BMGBGebV)) such applications are subject to fees.

B.4. Is the export of medicinal products also considered marketing? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, generally the export of medicinal products can fulfil the legal requirements for marketing as defined by Section 31 sub-section 1 sentence 1 number 1 AMG. A precondition for this is that the batch release of the licensed medicinal product also …

B.2. Does the term 'marketing' include the dispensing of free physicians’ samples supplied by pharmaceutical entrepreneurs? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes. Since samples supplied by pharmaceutical entrepreneurs can be dispensed to physicians on the basis of Section 47 sub-section 4 AMG, they are also considered marketed within the definition of the AMG.

D.7. Is a notification of interruption of marketing also required for suspended marketing authorisations? Date: 09. September 2008 Topics: Licensing Type: FAQ

Yes, notifications in accordance with Section 29 sub-sections 1b and 1c AMG and with Section 141 sub-section 7 AMG are to be separated procedurally from the provisions of Section 31 sub-section 1 number 1 AMG. This means that the notifications have …

B.5. When does the sunset clause ticker start counting in Germany? Date: 09. September 2008 Topics: Licensing Type: FAQ

As a matter of principle, the end of the shelf-life of the batch last placed on the market by the marketing authorisation holder is counted.

D.3. Are notifications for medicinal products licensed centrally with the EMA also to be submitted? Date: 09. September 2008 Topics: Licensing Type: FAQ

Only licenses within the jurisdiction of the BfArM are subject to the notification procedure. As the EMA is responsible for centralised marketing authorisations, the BfArM does not have to be informed.

D.6. Are notifications required for medicinal products the marketing authorisation of which was renounced by the marketing authorisation holder in accordance with Section 31 sub-section 1 number 2 AMG in conjunction with Section 31 sub-section 4 AMG and which are now still marketed in accordance with Section 31 sub-section 4 AMG? Date: 09. September 2008 Topics: Licensing Type: FAQ

There is no longer a notification obligation for expired marketing authorisations. The prerequisite for such an obligation is an existing license. The renunciation of marketing authorisation in accordance with Section 31 sub-section 1 number 2 …

D.5. Does a renewed notification of marketing have to be made if there was a marketing alliance and the co-marketer is now acting as the pharmaceutical entrepreneur for this product or if a marketing authorisation is transferred? Date: 09. September 2008 Topics: Licensing Type: FAQ

No new notification is necessary if there are no changes in the marketing status. This applies to co-marketing as well as to transfer of licenses.