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".
Informationsbeauftragte | 56 KB Formular zur Meldung eines Informationsbeauftragten gemäß § 56 AMG 14/02/2023 Information on inspection preparation L_I66_Pre_Inspection_Package_GMDP | 195 KB Informationen zur
medicines agencies. The Austrian Medicines and Medical Devices Agency had its BEMA V visit in March 2023. For more information please visit HMA .
responsibility, as applicable. Customer information on complaints and appeal management | 191 KB 01/02/2023 Emergency Contact Number Tel.: +43 (0) 664 831 28 43 Please note: The emergency number should only
Authorisation and Lifecycle Management of Medicines (L_Z34) | 1 MB 05/12/2023 Guidance Notes Medicine Shortages (L_I242) | 1 MB 07/04/2023 Further information regarding electronic application forms (eAFs) and
processing of renewals in the Mutual Recognition and Decentralized Procedures” , version dated February 2023, the submission of an “Addendum to the clinical overview” is no longer required. AT=RMS: routinely
12/10/2023 103. Anlage der Geschäftsordnung des BASG | 345 KB 05/05/2023 102. Anlage der Geschäftsordnung des BASG | 341 KB 13/03/2023 101. Anlage der Geschäftsordnung des BASG | 156 KB 20/01/2023 100.
website at this link . MRP/DCP statistics for 2023. The CMDh has presented its annual statistics on DC/MR procedures for 2023 according to the CTS database. In 2023, Austria as RMS was in 7th place for finalised [...] The update takes into account the new standard renewal procedure, which was introduced in February 2023 and specifies whether the requirements for a renewal, a variation or both apply. It also lists those [...] of committees and working parties RMS flyer Allocation scheme Current slot matrix NEWSTICKER 31.10.2023 RECENT COMMITTEE NEWS Overview of EU safety assessment outcomes. Marketing authorisation holders are
Regulation New Transition of clinical trials of medicinal products - the countdown is on! January 31, 2023 All ongoing clinical trials in the EU need to be converted to the Clinical Trials Information System
improve the usability and transparency of the CEP. The resulting CEP 2.0 was implemented on September 1, 2023. Further Information Database for information on CEPs granted by the EDQM: Search Certification Database [...] product Changes necessary due to performed the risk assessment had to be submitted by October 1st, 2023. CAVE: Please note that set deadlines for risk assessment (Step 1, 2 and 3) as described above for [...] medicinal product Changes necessary due to the performed risk assessment had to be submitted by July 1st, 2023. CAVE: Please note that set deadlines for risk assessment (Step 1, 2 and 3) as described above for