Official announcements
messages in brief
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04/05/2011
Based on recent follow-up requests from the Drug Quality and Regulatory Affairs National Procedures Divisions, a list of the most frequently submitted complaints was compiled. In each case, the "Top Five" for new and renewal requests are summarized…
messages in brief
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03/05/2011
On May 3, 2011, the Ordinance of the Federal Office for Safety in Health Care on the Electronic Transmission of Applications and Notifications (Electronic Submission Ordinance 2011 - EEVO 2011) was published in the Official Gazette of the Federal…
messages in brief
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02/05/2011
Hip joint endoprostheses are medical devices of the highest risk class (class 3). These medical devices must undergo a development program with clinical studies. If the benefit-risk profile is appropriate, the device is certified by a notified body…
messages in brief
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02/05/2011
Before using the web portal for the first time, registration of the organization is required. In the process, the authorization within the meaning of §§ 4 and 13 AWEG is verified. After successful registration, the applicant receives a user name and…
messages in brief
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29/04/2011
On possible radioactivity
Replacement
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Medicines
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29/04/2011
In a letter dated April 29, 2011, the marketing authorization holder informed its customers that the two batches had to be exchanged because routine stability tests had revealed that the test values for active ingredient release and disintegrability…
Replacement
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Medicines
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28/04/2011
The marketing authorization holder has informed its supplied customers by letter dated April 28, 2011, that a small piece of glass has been detected in a vial of the above mentioned batch. As a precaution, Mallinckrodt/Covidien (NL) is recalling the…
Replacement
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Medicines
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27/04/2011
Baxter Healthcare has identified elevated levels of endotoxin in some batches of the above peritoneal dialysis solutions at its manufacturing facility in Castlebar, Ireland, posing a risk of aseptic peritonitis. Since December 2010, five batches have…
messages in brief
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26/04/2011
The background to the recent discussions is not a 'new' document from the European Commission, but the 2004 Directive 2004/24 EC, which defines traditional herbal medicinal products and sets the regulatory framework for them across the EU. This…
