Official announcements
messages in brief
|
17/07/2019
Manufacturers of an implantable device shall provide information for identification of the device on an implant card in accordance with Article 18 MDR. More detailed guidance on a uniform format of an implant card have now been published on the…
messages in brief
|
16/07/2019
For more information on this topic, follow the link to the security features .
Recall
|
Medicines
|
03/07/2019
The marketing authorisation holder informed its customers on July 3, 2019 that below mentioned batch of „Elotrace - Infusionszusatz“ show black visible particles.
Recall
|
Medicines
|
14/05/2019
The marketing authorisation holder informed its customers on May 13, 2019 that overweight capsules may be packed and distributed to the market.
messages in brief
|
10/05/2019
The authorisation status of allergen products, both for diagnosis and therapy, in the European Union is heterogeneous. In order to facilitate harmonisation throughout the EU, the CMDh Drafting Group on harmonisation of the regulatory approaches for…
messages in brief
|
07/05/2019
The Commission Implementing Decision is published. Further information can be found under:…
Recall
|
Medicines
|
26/04/2019
"MEDIKUS medizintechnische und pharmazeutische Vertriebs GmbH" informed its customers on April 26, 2019 that metallic particles were detected in the infusion bags.
messages in brief
|
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
|
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…
Recall
|
Medicines
|
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.