Official announcements
Search narrowed by
messages in brief
|
09/07/2020
The EC has published a useful summary of applicable EU rules after the end of the transition period. You can find the link here on the website of the BASG.
messages in brief
Medicines
|
20/04/2020
Central contact points in each federal state survey needs and coordinate distribution
messages in brief
|
12/03/2020
NTA Vol. 2C: The "Guideline on the Packaging Information of medicinal products for human use authorised by the Community" - so called "Blue-Box Guideline für zentralen Zulassungen" can be found on the following website:: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/2018_packaging_guidelines_en.pdf
messages in brief
|
24/01/2020
The National Immunization Schedule 2020 is now available.
Safety warnings
|
messages in brief
|
17/09/2019
Measures at EU level At the request of the European Commission, the European Medicines Agency (EMA) has begun reviewing medicines containing ranitidine after investigations found contamination with N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen based on animal studies. It is also present in small amounts in some…
messages in brief
|
26/07/2019
Situation in Austria Imurek-50 mg Film-Coated Tablets are currently temporarily unavailable due to increased demand beyond national borders, and associated capacity constraints at the manufacturer. This information is publicly available on the website of the Federal Office for Safety in Health Care (BASG) at www.basg.gv.at in the so-called Sales…
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-products/accessible-patient-information-leaflet/ .
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 Medicines Control Laboratory) while he is still testing them himself. Complete documentation is not necessary at that point of time. By that means, a lot of time can be saved. When all necessary documents…
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 MDR. More detailed guidance on a uniform format of an implant card have now been published on the website of the European Commission. According to MDR/IVDR, manufacturers and authorised representatives…
messages in brief
|
16/07/2019
For more information on this topic, follow the link to the security features .
