What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
For the RSS feed with daily notification of updates, use the link: RSS feed to "what's new".
Search narrowed by
to mid-2023, the BASG provided the current, German-language Summary of Product Characteristics for centrally approved COVID-19 vaccines in Europe. This service was discontinued in November 2023. For the [...] Catalogue " list. Vaccination recommendations of the Austrian NIG . Current vaccine list | 157 KB 14/12/2023 List of vaccines no longer authorised If you find a vaccine name in your vaccination pass that does [...] been used in Austria since 1950 are included in this list. Vaccine list since 1950 | 123 KB 19/09/2023 Official Vaccination Recommendations in Austria The " Austrian Vaccination Plan " contains all current
(F_L381) | 44 KB 01/11/2018 Released Products 2006-2023 Plasma derived products 2006-2023 (diagram) Plasma pools 2006-2023 (diagram) Vaccines 2006-2023 (diagram) Special Services to Shorten and Simplify
medicinal products - in German only Arzneispezialitäten Übersicht 2023 | 110 KB 02/02/2024 Zulassungen Registrierungen Zusatzdaten 2023 | 99 KB 02/02/2024 MRP/DCP AT RMS The CMDh publishes bi-annual/annual
will also be made available as a recording. BASG fee schedule for clinical studies As of 01 January 2023 , an updated fee tariff of the BASG was put into force. From this date, index-adjusted tariffs will
the requirements for medicinal products for human use in the document 'Blue-box' requirements may 2023 published on the CMDh website in the section „ Procedural Guidance – Application for MA “. The Blue
ongoing, the amended PL will be authorised as part of the dossier. Reference: CMDh/258/2012/Rev.May 2023 8. Do these new provisions apply to parallel-imported medicinal products? Yes. 9. If the regulation
II National fees Appeal procedure National contact point and concerned ethics committees March 28, 2023 The national legislation supplementing Regulation (EU) 536/2014 ("Clinial Trials Regulations", "CTR") [...] an agreement. This agreement will be published shortly. Decision by the Federal Office December 14, 2023 The decision on an application (initial application or substantial modification) is made by the Federal [...] authorised, the negative decision is the basis for any appeal proceedings. National Applicant March 28, 2023 Regulation (EU) 536/2014 no longer provides for a national applicant. The applicant according to the
30 Dec 2023, which defines the implementation of the Veterinary Medicinal Products Regulation (EU) 2019/6 and supplementary provisions at national level ( https://www.ris.bka.gv.at/eli/bgbl/I/2023/186/20231230
application at BASG after 01.01.2024. 19/12/2023 Archive of Fees Fees 01.01.2023 | 297 KB The fees valid on the date of application at BASG after 01.01.2023. 16/12/2022 Gebührentarif 15.08.2022 | 560 KB
Safety of Medicinal Products (MSSG) Provision of data on the availability of antibiotics during winter 2023/24 for the EU-wide assessment of the situation via EMA and HERA Develop and implement the national [...] of the European Shortages Monitoring Platform (ESMP) by February 2025. The ESMP roadmap as of June 2023 is publicly available on the EMA website. The BASG is also working in this area to be able to provide [...] and EMA have published the first version of the Union list of critical medicines on the 12 December 2023. It contains more than 200 active substances of medicines for human use considered critical for healthcare