Exchange of unbuffered and weakly buffered infusion solutions. See associated files.

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.

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…

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.…