BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

430 results

Results per page: 10 20 30

Selected filter

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 …

Is an application for authorisation of an "integrated" protocol, which combines several parts possible at the BfArM? Date: 02. December 2008 Topics: Licensing Type: FAQ

In accordance with Directive 2001/20/EC, the principle "Each clinical trial must have a primary question" must be observed in clinical trials. In this context, a clinical trial may include several parts, provided the principle of a single …

What shall be submitted as a plan for further treatment? Date: 02. December 2008 Topics: Licensing Type: FAQ

In this context, applicants should describe which medical treatment the trial subjects will receive after completion of the clinical trial. Normally, patients will continue to receive their standard therapy or they will continue to be treated …

Which documents will be validated by the Subunit 'Clinical Pharmacology'? Date: 02. December 2008 Topics: Licensing Type: FAQ

In the formal validation, the Subunit 'Clinical Pharmacology' inspects the application form “Request for Authorisation” (parts E and F) with regard to mistakes or inconsistencies. Furthermore, the following documents are examined with respect to the …

What needs to be considered in paediatric trials? Date: 02. December 2008 Topics: Licensing Type: FAQ

The German Medicines Act (Arzneimittelgesetz, AMG) stipulates special safety provisions for minors participating in clinical trials. For all minors the provisions of § 40 AMG Section 40 sub-section 4 of the AMG apply; in addition, for minors …

Do special documents have to be submitted for paediatric trials? Date: 02. December 2008 Topics: Licensing Type: FAQ

Pursuant to Section 40 sub-section 4 number 2 of the German Medicines Act (Arzneimittelgesetz, AMG), a paediatric trial may only be conducted if clinical trials performed on adults or other research methods cannot be expected to produce satisfactory …

How often are paediatric trials currently submitted for authorisation at the BfArM? Date: 02. December 2008 Topics: Licensing Type: FAQ

Currently, approximately 6 % of all clinical trials conducted in Germany and approved by the BfArM are paediatric trials. Most often, clinical trials on minors are conducted in the fields neurology and psychiatry, respiratory tract, and …

Which objections regarding the trial protocol are the most frequent content-related objections in authorisation procedures? Date: 02. December 2008 Topics: Licensing Type: FAQ

Which objections regarding the trial protocol are the most frequent content-related objections in authorisation procedures?

  • The most frequent content-related objections regarding the trial protocol are:

  • inadequate risk-benefit …

Should a separate protocol be prepared for an extension phase of a clinical trial in which all subjects will receive verum or should the extension phase be submitted as an amendment to the protocol already authorised? Date: 02. December 2008 Topics: Licensing Type: FAQ

Whether the extension “treatment” is an amendment to the protocol or whether it is considered an “open-label extension study” depends on the objective and on the design of the previous study.

  • If the primary and secondary objectives …

How often shall the Investigator’s Brochure be updated? Date: 02. December 2008 Topics: Licensing Type: FAQ

Pursuant to Directive 2005/28/EC of the Commission dated 8 April 2005 Article 8 (3), the sponsor shall validate and update the Investigator’s Brochure, if necessary, at least once a year. If an update of the Investigator’s Brochure is not considered …

Which requirements should a trial protocol fulfil from the BfArM's point of view? Date: 02. December 2008 Topics: Licensing Type: FAQ

The trial protocol should contain information regarding the following issues, in compliance with the Guideline for Good Clinical Practice (CPMP/ICH/135/95), Chapter 6. Clinical trial protocol and protocol amendment(s):

  • table of …