BfArM - Federal Institute for Drugs and Medical Devices

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Cover letter BfArM doc, 38KB, File does not meet accessibility standards Date: 01. April 2010 Topics: Licensing Type: Download

If an electronic submission is made according the rules of "electronic only" you should mention this explicitly on the package and on the cover letter.

How do I report data regarding the Sunset Clause? Date: 26. March 2010 Topics: Licensing Type: FAQ

A dedicated application at PharmNet-bund-Portal can be used for electronic reports regarding the Sunset Clause. An additional paper version of the report is not required. For details follow the link.

Processing Statistics of the BfArM 2009 PDF, 257KB, File does not meet accessibility standards Date: 23. March 2010 Topics: Licensing Type: Download

State: March 2010

History of Sequences doc, 68KB, File does not meet accessibility standards Date: 26. February 2010 Topics: Licensing Type: Download

HiS

History of Sequences doc, 68KB, File does not meet accessibility standards Date: 26. February 2010 Topics: Licensing Type: Download

HiS

End User License Agreement PDF, 137KB, File does not meet accessibility standards Date: 26. February 2010 Topics: Licensing Type: Download

EULA

In what form should the national texts be submitted? Date: 01. February 2010 Topics: Licensing Type: FAQ

The national texts are to be inserted into the “Bescheidmaske”, which is made available on the BfArM homepage.

Submissions without a “Bescheidmaske” will be rejected unprocessed.

For each strength, a separate “Bescheidmaske” must be …

What has to be considered when preparing national translations? Date: 01. February 2010 Topics: Licensing Type: FAQ

If the final English product information is based upon a CHMP referral or a centralised procedure, the corresponding German translation has to be used.

If parallel procedures are concluded with identical final English product information, …

Paediatric Worksharing according to Article 45 and 46 Regulation (EG) No. 1901/2006 Date: 31. August 2009 Topics: Licensing Type: Article

The BfArM has implemented a specific procedure for variations (national, MRP and DCP) based on the assessment of paediatric clinical trials with authorised medicinal products (in accordance with Article 45 of Regulation (EC) No1901/2006, Paediatric …

Processing Statistics of the BfArM 2008 PDF, 351KB, File does not meet accessibility standards Date: 23. March 2009 Topics: Licensing Type: Download

State: March 2009

List of Change Items Version 1.6 PDF, 77KB, File does not meet accessibility standards Date: 11. March 2009 Topics: Licensing Type: Form

German - English

Explanatory Notes on the enforcement of the Ordinance on the Submission of Documents within Licensing and Renewal Procedures for Medicinal Products PDF, 496KB, File does not meet accessibility standards Date: 29. January 2009 Topics: Licensing Type: Download

Explanatory Notes on the enforcement of the Ordinance on the Submission of Documents within Licensing and Renewal Procedures for Medicinal Products

Are there specific data requirements for clinical trials with children? Date: 13. January 2009 Topics: Licensing Type: FAQ

Yes, in accordance with the "Guideline on the Need for Non-Clinical Testing in Juvenile Animals on Human Pharmaceuticals for paediatric indications" for all clinical trials with children studies of repeated-dose-toxicity, genotoxicity, …

Presentation of documentary evidence pursuant to Article 7 of the European Paediatric Medicines Regulation (EC) no. 1901/2006, mandatory from 26 July 2008 Date: 13. January 2009 Topics: Licensing Type: Article

Presentation of documentary evidence pursuant to Article 7 of the European Paediatric Medicines Regulation (EC) no. 1901/2006, mandatory from 26 July 2008

EU-regulation on medicinal products for children Date: 13. January 2009 Topics: Licensing Type: Article

EU-regulation on medicinal products for children

Advice on the submission of information about use of authorised medicinal products in children as required by Articles 45 and 46 of the Paediatric Medicines Regulation (EC) no. 1901/2006 Date: 13. January 2009 Topics: Licensing Type: Article

Advice on the submission of information about use of authorised medicinal products in children as required by Articles 45 and 46 of the Paediatric Medicines Regulation (EC) no. 1901/2006

Which information should be included in the cover letter? Date: 09. December 2008 Topics: Licensing Type: FAQ

For every CTA, please provide information about previous submissions / filings (submission number) appropriate to the Investigational Medicinal Product in the cover letter.

If a scientific advice meeting with the competent authorities of …

What are the requirements for first-in-man clinical trials from a clinical point of view? Date: 02. December 2008 Topics: Licensing Type: FAQ

In the cover letter, it should be mentioned that within the clinical trial a medicinal product is meant to be administered in humans for the first time. In this context, it should already be discussed whether the medicinal product is a potential …

Which formal deficiencies are most frequently found in application documents? Date: 02. December 2008 Topics: Licensing Type: FAQ

Often, there is no justification pursuant to Section 7 sub-section 2 number 12 of the GCP Ordinance specifying the appropriateness of the chosen sex distribution of trial subjects for detecting possible sex-specific differences in the efficacy …