Following the EMA Management Board confirmation and announcement in May 2017 that the database has achieved full functionality, the new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and…

BASG-Dialogue "Quality Day" on 29 May 2018 and 13 June 2018 During this event you will hear a lot about relevant documentation in Module 3. Furthermore you have the possibility to meet the Quality Assessors and to address your questions directly to…

The OMCL of the Austrian Medicines and Medical Devices Agency has due to automation of analytical methods and optimization of processes significantly increased the capacity for official control authority batch testing of plasma products and vaccines.…

In February 2017 an updated version of the eSubmission-Roadmap was published, setting implementation dates for mandatory use of eCTD/VNeeS format in purely national new applications (01.07.2018) respectively for purely national variation and renewal…

The new RMS Flyer 2018 has been published on the BASG website: https://www.basg.gv.at/en/news-center/public-information-campaigns/austria-as-rms/rms-flyer/ . Looking forward to be the RMS for your products in the upcoming future!