invited to fill in this form: https://ec.europa.eu/eusurvey/runner/2023_MAHSurvey_SPCH , which may be submitted by before 31st of May 2023 . For any question regarding the form, please contact the CMDv s

– 31.12.2023 | 173 KB 29/01/2024 Berichtszeitraum 27.12.2020 – 30.09.2023 | 172 KB 20/10/2023 Berichtszeitraum 27.12.2020 – 30.06.2023 | 173 KB 01/08/2023 Berichtszeitraum 27.12.2020-31.03.2023 | 166 KB [...] KB 05/04/2023 Berichtszeitraum 27.12.2020-31.12.2022 | 165 KB 04/01/2023 Berichtszeitraum 27.12.2020-30.11.2022 | 164 KB 09/12/2022 Berichtszeitraum 27.12.2020-31.10.2022 | 169 KB 11/11/2022 Berichtszeitraum

There is an annual update of the xml file. AntibiotikaMengenstromanalyseASP_DDD_DCD.xml | 333 KB 26/09/2023 AntibiotikaMengenstromanalyseASP_DDD_DCD.xsd | 3 KB 31/03/2021

MedSafety Week 2023 "Who can report?" - a call to patients and healthcare professionals to report suspected adverse reactions during #MedSafetyWeek: November 6-12, 2023. The Federal Office for Safety in

ted, or have more frequent or severe adverse events compared to the Pegunigalsidase Alfa. NA 20.1.2023 Beendet Closed Responsible person: Chiesi Farmaceutici S.p.A Via Palermo 26/A 43122, Parma, Italy

Referenced at:

• Compassionate use/Named Patient Use

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

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

specify] (for example: refer to nic notification) Bionorica research GmbH Mitterweg 24, 6020 Innsbruck 07.2023 ic full 8 GLP Prüfeinrichtung Takeda Manufacturing Austria AG (Takeda Manufacturing Austria AG, a [...] 67, 1221 Vienna Test sites: • Benatzkygasse 2-6, 1221 Vienna • Industriestraße 67, 1221 Vienna 04.2023 ic full 9 9: Safety Pharmacology, Virus and Prion Biosafety Studies New name since 01/2022 Formerly: [...] mbH, HEALTH – Institute for Biomedicine and Health Sciences Neue Stiftingtalstraße 2, 8010 Graz 10.2023 ic full 1, 8 BASG / AGES MEA Institute Surveillance Traisengasse 5 1200 Vienna, Austria F_INS_VIE

Referenced at:

• Good Laboratory Practice (GLP)

gemäß Art. 62 Verordnung (EU) 2019/6 iVm § 14 Tierarzneimittelgesetz idgF (TAMG, BGBl. I Nr. 186/2023) für zugelassene Veterinärarzneimittel verwendet. Für Änderungen nach Art. 62 Verordnung (EU) 2019/6

Referenced at:

• Electronic application

Änderungen gegenüber der Vorversion

Referenced at:

• Electronic application