Official announcements
messages in brief
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23/05/2011
The "Standards for the Preparation for Use, the Application and the Disposal of Cytostatic Drugs" are quality standards according to § 2 Z 12 of the Health Care Quality Act (GQG). These standards concern health care facilities and summarize the…
Replacement
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Medicines
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11/05/2011
The marketing authorization holder informed its supplied customers in a letter dated May 11, 2011, that due to reports of an unpleasant, moldy odor, the affected batches must be recalled. This odor emanates from the primary packaging (plastic…
Replacement
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Medicines
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05/05/2011
The marketing authorization holder informed its supplied customers by letter dated May 3, 2011, that an atypically elevated value of a known, characterized degradation product was detected in the batches listed above. However, the values are within…
Medicines
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05/05/2011
Decree concerning "Standards for the preparation for use, application and disposal of cytostatic drugs" (acc. to § 2 Z 12 GQG). See related files.
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…
