Official announcements
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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…
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07/05/2019
The Commission Implementing Decision is published. Further information can be found under:…
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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…
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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…
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21/02/2019
For more information on this topic, follow the link to the security features .
Safety warnings
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14/02/2019
During the transitional phase, strict limits are already in place for these impurities.
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04/02/2019
The National Immunization Schedule 2019 ("Österreichischer Impfplan") is now available. link: https://www.sozialministerium.at/site/Gesundheit/Krankheiten_und_Impfen/Impfen/Oesterreichischer_Impfplan_2019
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04/02/2019
In December 2018 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a guideline on the assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products. The calculated threshold values are intended to…
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04/02/2019
The EMA published a revision of the “Guideline on the environmental risk assessment (ERA) of human medicines” on 30 November 2018. The guideline is now open for public consultation until 30 June 2019. The purpose of the ‚Guideline on Environmental…
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22/01/2019
A team from the Austrian Federal Office for Safety in Health Care (BASG) was a guest at the Paul Ehrlich Institute (PEI) on Jan. 14, 2019. The aim was to cooperate more closely in the future in the regulation of medicinal products for the diagnosis…