Messages in brief
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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Information on the introduction of safety features in the form of individual identification marks on each individual drug package. (Update)
messages in brief
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21/02/2019
For more information on this topic, follow the link to the security features.
Valsartan / Sartan-containing drugs: Pharmaceutical companies to review manufacturing processes to avoid occurrence of nitrosamine-containing impurities
Safety warnings
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messages in brief
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14/02/2019
During the transitional phase, strict limits are already in place for these impurities.
Valsartan / Sartan-containing drugs: Pharmaceutical companies to review manufacturing processes to avoid occurrence of nitrosamine-containing impurities
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