Messages in brief
BREXIT Top-News
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03/02/2020
Updated information on Brexit and the transition period can be found here on the BASG website.
BREXIT
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Creating Accessible Documents New
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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
Creating Accessible Documents
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National Immunization Schedule 2020
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24/01/2020
The National Immunization Schedule 2020 is now available.
National Immunization Schedule 2020
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Round table on "Availability of medicines in Austria" (2)
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21/10/2019
The second round table discussing the availability of medicines in Austria took place on October 15, 2019.
Round table on "Availability of medicines in Austria" (2)
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Accessible patient information leaflet
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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
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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
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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…
The authorisation status of allergen products
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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
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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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Revision of the EMA “Guideline on the non-clinical requirements for radiopharmaceuticals”
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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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