Official announcements
messages in brief
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24/04/2019
Article 54 of the MDR regulates the consultation procedure related to the clinical evaluation of certain class III and class IIb devices. Regarding the exemption provisions to this procedure, an interpretative document has been published. Devices…
messages in brief
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23/04/2019
The purpose of the ‚Draft guideline on the non-clinical requirements for radiopharmaceuticals‘ (EMA/CHMP/SWP/686140/2018) is to provide guidance on the required nonclinical data needed to support clinical development and marketing authorisation of…
Safety warnings
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Blood & Tissue
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17/04/2019
Only available in German
Safety warnings
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Blood & Tissue
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17/04/2019
Only available in German
Safety warnings
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Blood & Tissue
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17/04/2019
Only available in German
Safety warnings
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Blood & Tissue
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09/04/2019
Only available in German
Enforcement
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06/04/2019
The opportunities of stem cell and other cell-based therapies raise great hopes in physicians as well as patients. Due to novel therapies, major progress is expected particularly in the areas of difficult-to-treat, chronic and incurable diseases. In order to prevent illegal profiteering, it is important for authorities to monitor this quickly evolving therapeutic area.
Recall
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Medicines
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05/04/2019
The marketing authorisation holder informed its customers on April 4, 2019 that there is a risk that "Parkemed - Suspension zur oralen Anwendung" will likely contain levels of Lead (Pb) and Lithium (Li) which exceed the Permitted Daily Exposure (PDE) levels.
Recall
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Veterinary Medicines
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26/03/2019
The marketing authorisation holder and its distribution partner informed their customers on March 25, 2019 that particles had been detected in individual batches.
Recall
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Medicines
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11/03/2019
The marketing authorisation holder informed its customers on March 6, 2019 that the marketing of „Tetraspan 60 mg/ml Infusionslösung“ and „Venofundin 60 mg/ml Infusionslösung“ is ceased permanently for economic reasons.
