BfArM - Federal Institute for Drugs and Medical Devices

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Does Section 42b AMG also apply to the currently still "fictively licensed" medicinal products? Date: 20. June 2012 Topics: Licensing Type: FAQ

Medicinal products that are deemed to be authorised for marketing as defined by Section 105 sub-section 1 AMG, are generally subject to all provisions of the AMG, i.e. the specifications of Section 42b sub-section 2 AMG and the corresponding …

How are biosimilars viewed with regard to the reporting obligation in accordance with Section 42b AMG? Date: 20. June 2012 Topics: Licensing Type: FAQ

Medicinal products licensed as biosimilar require confirmatory clinical trials in order to obtain a marketing authorisation. Therefore, these are to be submitted in accordance with Section 42b sub-section 1 AMG. Clinical trials with licensed …

Do the statements on test or reference investigational products have to include all dose strengths used or is it sufficient to enter a medicinal product with one dose strength standing for all strengths? Date: 20. June 2012 Topics: Licensing Type: FAQ

Different dose strengths also have different marketing authorisation numbers; therefore, linkage in the Drug Information System makes it necessary to list all strengths.

How is a clinical trial evaluated that was started prior to marketing authorisation but completed after granting of the marketing authorisation? Date: 20. June 2012 Topics: Licensing Type: FAQ

If the medicinal product was licensed at any time during the clinical trial, a result report in accordance with Section 42b sub-section 2 AMG is to be submitted. This also applies if the medicinal product was not yet licensed at the time the …

If a medicinal product was licensed before 1 January 2011, the transitional regulation pursuant to Section 145 AMG applies, i.e. the pharmaceutical entrepreneur must transmit the result reports at the latest by 1 July 2012 if the medicinal product is placed on the market in Germany. What is to be done if the marketing is stopped prior to 1 July 2012? What is to be done if marketing is resumed after 1 July 2012? Date: 18. June 2012 Topics: Licensing Type: FAQ

As already stated above, the publication obligation in accordance with Section 42b sub-section 1 AMG applies to medicinal products that are on the market; this is also true for Section 145. If a medicinal product is not (or no longer) being …

How is a medicinal product the marketing authorisation of which has been suspended dealt with in accordance with Section 42b sub-section 1 AMG? Date: 18. June 2012 Topics: Licensing Type: FAQ

It is against the law to place a medicinal product on the market if its marketing authorisation has been suspended. Thus, there is also no legal obligation to submit result reports pursuant to Section 42b AMG and/or Section 145 AMG during the …

What must be considered both when submitting notifications of variations of the pack sizes as well as notifications of variations of primary packaging? Date: 15. June 2012 Topics: Licensing Type: FAQ

When changing the pack size (addition or deletion), the type of immediate packaging material to which this change refers always has to be stated concurrently. Vice versa, if the type of immediate packaging material is altered (removal of …

Publication of the results of clinical trials in accordance with Section 42b AMG Date: 01. June 2012 Topics: Licensing Type: Article

BfArM has updated the procedural advice on the reqiurements regarding the publication of the results of clinical trials in accordance with Section 42b of the German Medicinal Products Act

Processing Statistics of the BfArM 2011 PDF, 324KB, File is accessible Date: 05. March 2012 Topics: Licensing Type: Download

State: March 2012

Processing Statistics of the BfArM 2010 PDF, 110KB, File is accessible Date: 28. February 2011 Topics: Licensing Type: Download

State: February 2011

Example 1 PDF, 25KB, File does not meet accessibility standards Date: 06. January 2011 Topics: Licensing Type: Form

German - English

Example 2 PDF, 24KB, File does not meet accessibility standards Date: 06. January 2011 Topics: Licensing Type: Form

German - English

Form for variation notification
new set of forms
doc, 48KB, File does not meet accessibility standards
Date: 04. January 2011 Topics: Licensing Type: Form

(available in German only)

B.6. When is the competent authority to be notified of the placing on the market? Date: 03. January 2011 Topics: Licensing Type: FAQ

In accordance with Section 29 sub-section 1b AMG, the marketing authorisation holder shall notify the competent federal higher authority immediately of the date on which the medicinal product is to be placed on the market, taking into consideration …

Tabelle doc, 45KB, File does not meet accessibility standards Date: 23. December 2010 Topics: Licensing Type: Download

Zoledonsäure Flying Team “FT

Prevention of drug-associated risks, Stage II
Medicinal products prepared using plants of Aristolochiaceae of the Asarum genus
PDF, 94KB, File is accessible
Date: 04. November 2010 Topics: Licensing Type: Download

Prevention of drug-associated risks, Stage II
Medicinal products prepared using plants of Aristolochiaceae of the Asarum genus

Are other electronic compilations accepted besides eCTD or NeeS? Date: 02. August 2010 Topics: Licensing Type: FAQ

Yes, but only if a full paper dossier is provided at the same time (all modules need to be printed). In case of electronic submissions not in accordance with the eCTD specifications or the NeeS guideline a paper dossier is required and the …

Do I still have to comply with the AMG-Submission Ordinance (AMG-EV)? Date: 02. August 2010 Topics: Licensing Type: FAQ

No, as long as you comply with the eCTD or NeeS requirements for electronic submissions and if you place all documents required by the eSubmission Ordinance (which were otherwise sent by e-mail) in the folder <sequence>workingdocuments.

The …

How will the confirmation of receipt be sent? Date: 02. August 2010 Topics: Licensing Type: FAQ

If you have provided information about your e-mail contact, BfArM will send the confirmation of receipt via e-mail, otherwise we will use conventional mail.

When is a history of sequences required? Date: 02. August 2010 Topics: Licensing Type: FAQ

Any time an electronic submission in eCTD or NeeS format is submitted, an updated “history of sequences“ named “tracking.pdf“ must be placed in the same folder as the cover letter and submitted in paper as well. This will support transparency and …

What should the Cover Letter contain? Date: 02. August 2010 Topics: Licensing Type: FAQ

The cover letter lists all medicinal products for which marketing authorisation is sought and to which the eCTD / NeeS submission applies, together with the corresponding procedure and processing numbers (ENR, "Eingangsnummern"). The electronic …

Can an ASMFs be submitted electronically? Date: 02. August 2010 Topics: Licensing Type: FAQ

Yes, the same requirements apply as for full dossiers for marketing authorisations. BfArM is willing to accept electronic submissions for ASMF according to the rules published on the EMA website. For details follow the link.

Is submission of a paper dossier still possible? Date: 02. August 2010 Topics: Licensing Type: FAQ

Basically, yes. However, it should be considered that the standard procedure cannot be followed in such cases and that delays cannot be excluded. In this case the eSubmission Ordinance (AMG-EV) also needs to be observed. Further advice can be found at

Advance payment (Vorschusserhebung) Date: 22. July 2010 Topics: Licensing Type: Article

Section 16 of the Administrative Cost Act (Verwaltungskostengesetz) provides that the performance of an official act on application may be made conditional on the payment of an appropriate advance up to the level of the estimated procedural …

Centralised Procedures Date: 12. April 2010 Topics: Licensing Type: Article

Centralised Procedures