Information to ensure the safety of Neupro. See related files.

Communication from the Federal Office for Safety in Health Care on Gardasil. You related file.

Information on the suspension of marketing of parenterally administrable drug products containing aprotinin. See related files.

Information on market withdrawal of Clobutinol-containing drugs (Silomat®) up to and including patient level. See related files.

Information on processing open registration and amendment requests submitted prior to Jan. 1, 2006. See related file.

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!

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…

According to eSubmission-Roadmap purely national variation and renewal applications have to be submitted mandatorily in eCTD/VNeeS format after January 1, 2019. Please find further information at https://www.basg.gv.at/en/eservices/ectdvnees/ .

As pubished an 29.06.2018 the Federal Office for Safety in Health Care (BASG), was obliged in an arbitration process according to § 14 of the Federal Disability Equality Act (BGStG) to request Holders of a Marketing…