Banks). 16. What changes does the revision of Annex 1 of the GMP Guideline have for my company? On 25.8.2023, a revision of Annex 1 of the GMP Guidelines will come into force, to which reference is also made

blood and blood components 04/12/2023 Haemovigilance Report 2022 | 1 MB Only available in German 11/10/2023 Haemovigilance Report 2021 | 567 KB corrected version of 14.09.2023 (only editorial changes compared [...] includes the annual summary report of all haemovigilance data of the Member States. Haemovigilanz_Bericht_2023 | 842 KB New Only available in German 02/09/2024 Report of the European Commission 2021 | 2 MB Summary [...] compared to the publication of 29.11.2022) - Only available in German 14/09/2023 Haemovigilance Report 2020 | 7 MB Only available in German 08/10/2021 Report of the European Commission 2020 | 1 MB Summary

Gazette I No. 23/2020, only apply to clinical trials submitted to the BASG before 31 January 2023. As of 31 January 2023, initial applications for approval of clinical trials of medicinal products must be submitted [...] only additional pages with questions to sponsors / NCAs, in order to confirm that after January 30th, 2023: no new EudraCT number is created for a trial conducted in EU/EEA : sponsors will need to confirm [...] the load CTA function is allowed to sponsors only for EudraCT CTAs submitted before January 31 st , 2023 . If the sponsor needs to create a CTA for the same trial but for a different NCA, the sponsor will

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