Prof. Dr. Karl Broich, President of the BfArM (Federal Institute for Drugs and Medical Devices) visits the AGES Medical Market Surveillance.

contact you via email in the quarter before the intended submission slot. Applicants cannot change the active substance/therapeutic group or the time slot agreed by themselves. Applicants are advised to inform

Up-to-date information from the 12.12.-15.12.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

providing BASG with necessary resources, staff and infra- structure. When carrying out sovereign activities, the employees of AGES MEA are acting on behalf of BASG. Responsibilities of AGES MEA include providing

Referenced at:

• Annual Reports and Facts Folder

Up-to-date information from the 07.11.-11.11.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

The fees valid on the date of application at BASG after 01.01.2023.

Referenced at:

• Fees

Up-to-date information from the 10.10.-13.10.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Up-to-date information from the 12.09-15.09.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

following notification type: Annual report/activity report (Haemovigilance) To the online submission (The online reporting is only available in German.) Annual activity report From 01.1.2022, blood establishments [...] is 30.04. of the following year! The annual activity report is submitted in the eService by selecting the following notification type: Annual report/activity report To the online submission (The online [...] reaction takes place in the eService by selecting the following notification type: Annual Report/Activity Report (Haemovigilance) To the online submission (The online reporting is only available in German

product is: §1 (18) "Generic medicinal product" means a medicinal product which must contain the same active substance in the same quantity and must also have the same pharmaceutical form (e.g. tablets, solution [...] the so-called bioequivalence (i.e. the substitutability of two medicinal products with the same active substance) with the reference medicinal product through appropriate studies. §1 (19) "Reference medicinal [...] a study that compares whether the blood of the test subjects contains exactly the same amount of active substance from the generic (test product) at the same time and in the same amount as from the reference