| Date |
Title |
Link |
| 30.12.2009 |
AMG-Submission Ordinance
On 1 January 2010, the BfArM published the new BfArM key. The validity of which expires on 12 July 2010.
Note: The validity period of the key published on 1 July 2009 will expire on 10 January 2010. |
 to article |
| 09.10.2009 |
Medicinal properties of skin and hand disinfectants for human use
According to the German Medicines Act (AMG) – also since the 15th Amendment of July17th 2009 – skin antiseptics and hand disinfectants are medicinal products, .... |
to article |
| 31.08.2009 |
Article 45 and 46 Regulation (EG) No. 1901/2006
Variations based on the assessment of paediatric clinical trials with authorised medicinal products
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 Worksharing). |
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| 30.03.2009 |
Safety risk concerning dental unit PROPHY RELAX
The patient chair of the dental unit PROPHY RELAX could suddenly drop down from the selected position. BfArM recommends all users to check on the bearings in the spindle drive. |
to article |
| 13.01.2009 |
Presentation of documentary evidence pursuant to Article 7 of the European Paediatric Medicines Regulation (EC) no. 1901/2006, mandatory from 26 July 2008 |
to article |
| 17.09.2008 |
FAQ Variations
FAQ regarding the sunset clause notification procedure - legal issues |
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| 07.08.2008 |
Information regarding confirmations of receipt in connection with clinical trials
Please note that until further notice we will not be sending out confirmations of receipt for the following documents in connection with clinical trials:
- notifications of non-substantial amendments
- final clinical trial reports
- annual safety reports
|
to article |
| 30.05.2008 |
Meeting report
The BfArM published the report of the “International Expert Meeting on Exploratory Clinical Trial Applications and Microdosing”
15 September 2007, BfArM, Bonn (Germany) |
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| 14.03.2008 |
Guide to the Submission of Applications for Marketing Authorisation of Medicinal Products
The Guide has been translated into English and is now available in addition to the updated German version. |
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| 22.02.2008 |
New navigation structure on our “Drugs” web pages
The navigation structure of the “Drugs” section of our web pages has been reorganised.
The previous pages and their contents have been sorted into new folders depending on the type of application. |
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| 05.09.2007 |
Australian expert at BfArM-Dialogue about usable package leaflets
The most appropriate preparing of package leaflets will be again the focus of a conference which is organised by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) taking place on Tuesday, September 11th, 2007, at the Wissenschaftszentrum of Bonn within their series of events „Das BfArM im Dialog“ actually announced as „User Testing – alternative methods and assessment in Europe“. |
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| 03.08.2007 |
Remote controlled X-ray systems: risk of collision in case of vertical diagnostic procedures
BfArM considers corrective measures concerning remote controlled X-ray systems mandatory in oder to reduce the risk of collision between moving parts and patients or users in case of vertical diagnostic procedures. |
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| 22.06.2007 |
RSS feeds available for field corrective actions concerning medical devices
The Federal Institute for Drugs and Medical Devices now gives the opportunity to obtain information about field corrective actions via RSS feed. Field Corrective Actions include the removal of medical devices from the market or any other corrective action on medical devices in use. |
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| 20.04.2007 |
Modifications of BfArM's email-system
The Federal Institute for Drugs and Medical Devices (BfArM) modified its e-mail system on 20 April 2007. Should you experience any difficulties when contacting the BfArM by e-mail please do not hesitate to call our helpdesk at +49-228-207-5555. |
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| 22.02.2007 |
Templates for Product Information and Package Leaflets
The Template for Product Information has been updated in chapter 4.8 (definition for frequency of adverse drug reactions). |
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| 11.01.2007 |
E-mail loss at BfArM - please resend e-mails
A technical malfunction in the BfArM's e-mail system has lead to a partial loss of incoming emails during the period from 2006/12/28 to 2007/01/02. Should you have sent e-mails to the institute during this time we kindly ask you to resend these mails because we cannot ensure that they have been delivered. |
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