the eService. In case you want to submit product information texts before the procedure has been activated, please attach them in a MS-word format (*.doc, *.docx) and if applicable, in a pdf-UA format for

Referenced at:

• FAQ online Service

Up-to-date information from the 06.11.-09.11.2023 meeting on new approvals, extensions of indication, newly published EPAR's 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

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

Up-to-date information from the 09.10.-12.10.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

CHESSMEN Board meets in Rome to discuss shortage prevention.

The Federal Office for Safety in Health Care (BASG) informs about new developments concerning counterfeits of the medicinal product Ozempic® (manufacturer: Novo Nordisk A/S). The existing BASG warnings of 12/10/2023, 19/10/2023 and 23/10/2023 remain valid. The manufacturer's mailing is supplemented with comprehensive patient information.

BASG informs about current developments and necessary measures in case of counterfeiting of the medicinal product Ozempic® in German presentation.

Up-to-date information from the 11.09.-14.09.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

is required. If the physician sample labelling is carried out by a qualified manufacturer as an activity on behalf according to Section 29 AMBO 2009, approval of this manufacturer in the dossier of the [...] the establishment (including inventory number). - Premises and, if applicable, equipment (coolers, active transport boxes, etc.) shall be qualified and maintained in accordance with GMP/GDP requirements [...] item 1.4.3 "Other" in the scope of authorisation of drug manufacturers, or under item 2.5 "Other activities" in the scope of authorisation of drug wholesalers. A list of overused equipment/compartments is