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mp_vol4_chap4_annex22_consultation_guideline_en.pdf
Page 1 of 6 Annex 22: Artificial Intelligence 1 Reasons for changes: Not applicable (new annex). 2 Document map 3 1. Scope 2. Principles 3. Intended Use 4. Acceptance Criteria
08.07.2025 Datei PD
Stakeholder_Comments_-_Annex_11_EMA_PICs.xlsx
Compilation - EMA publication <Date of submission> Submission of comments on Annex 11 Computerised Systems Please note that these comments and the identity of the sender will be published
08.07.2025 Datei PD
mp_vol4_chap4_consultation_guideline_en.pdf
Page 1 of 17 Chapter 4: Documentation 1 Reasons for changes: The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly 2 recommended that the current version of Chapter 4, on docum
08.07.2025 Datei PD
Stakeholder_Comments_-_Chapter_4_EMA_PICs.xlsx
Compilation - EMA publication <Date of submission> Submission of comments on Chapter 4 Documentation Please note that these comments and the identity of the sender will be published unles
08.07.2025 Datei PD
mp_vol4_chap4_annex11_consultation_guideline_en.pdf
Page 1 of 19 Annex 11: Computerised Systems 1 Reasons for changes: The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly 2 recommended that the current version of Annex 11 on Co
08.07.2025 Datei PD
agenda-prac-meeting-7-10-july-2025_en.pdf
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-u
08.07.2025 Datei PD
20250708_OJ_L_202501324_DE_TXT.pdf
DURCHFÜHRUNGSBESCHLUSS (EU) 2025/1324 DER KOMMISSION vom 7. Juli 2025 zur Änderung des Durchführungsbeschlusses (EU) 2019/1396 hinsichtlich bestimmter administrativer Aspekte im Zusammenhang mit E
08.07.2025 Datei PD
AG-Info-28-2025.pdf
BERLIN Friedrichstraße 134 10117 Berlin T. 030 | 308 75 96 - 0 F. 030 | 308 75 96 - 111 BONN Ubierstraße 71–73 53173 Bonn T. 0228 | 957 45 - 0 F. 0228 | 957 45 - 90 Pharma Deutschl
08.07.2025 Datei PD
Pharma_Deutschland_aktuell_128_2025.pdf
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07.07.2025 Datei PD
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