Messages in brief

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BREXIT Top-News

messages in brief | 03/02/2020
Updated information on Brexit and the transition period can be found here on the BASG website.
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Creating Accessible Documents New

messages in brief | 13/02/2020
According to § 14 of the Federal Disability Equality Act (BGStG) Marketing authorization holders are obliged to provide their Package Leaflets in an accessible format
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National Immunization Schedule 2020

messages in brief | 24/01/2020
The National Immunization Schedule 2020 is now available.
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Round table on "Availability of medicines in Austria" (2)

messages in brief | 21/10/2019
The second round table discussing the availability of medicines in Austria took place on October 15, 2019.
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Accessible patient information leaflet

messages in brief | 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…
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Time savings due to parallel submissions in batch release

messages in brief | 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…
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Medical devices: New information on implant card and person responsible for regulatory compliance

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…
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The authorisation status of allergen products

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…
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News

Update Community Referral Sartans

messages in brief | 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…
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Revision of the EMA “Guideline on the non-clinical requirements for radiopharmaceuticals”

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…
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