Messages in brief
Review of ranitidine-containing drugs due to possible contamination with NDMA.
Safety warnings
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messages in brief
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17/09/2019
Measures at EU level
At the request of the European Commission, the European Medicines Agency (EMA) has begun reviewing medicines containing…
Supply bottleneck Imurek
messages in brief
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26/07/2019
Situation in Austria
Imurek-50 mg Film-Coated Tablets are currently temporarily unavailable due to increased demand beyond national borders, and…
Accessible patient information leaflet
messages in brief
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18/07/2019
Please find new and updated FAQ's regarding "Accessible Patient Information Leaflet" at
https://www.basg.gv.at/en/medicines/faqs-about-medicinal-pro…
Accessible patient information leaflet
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Time savings due to parallel submissions in batch release
messages in brief
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18/07/2019
The concept of parallel submission in official control authority batch release means that the applicant sends samples to the BASG-OMCL (Official…
Time savings due to parallel submissions in batch release
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Medical devices: New information on implant card and person responsible for regulatory compliance
messages in brief
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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…
Information on the introduction of safety features in the form of individual recognition features on drug packages. (Update 2 - Stabilization phase until 09.02.2020)
messages in brief
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16/07/2019
For more information on this topic, follow the link to the security features.
The authorisation status of allergen products
messages in brief
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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…
The authorisation status of allergen products
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In order to facilitate…
Update Community Referral Sartans
messages in brief
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07/05/2019
The Commission Implementing Decision is published.
Further information can be found under: https://www.basg.gv.at/de/news-center/news/news-detai…
Update Community Referral Sartans
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Medical devices: Information on consultation procedures, registration of guideline products and registration deadlines published
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…
Revision of the EMA “Guideline on the non-clinical requirements for radiopharmaceuticals”
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…
Revision of the EMA “Guideline on the non-clinical requirements for radiopharmaceuticals”
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