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".
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