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
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
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
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
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
koenig
Hervorheben
08.07.2025
Datei
PD
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
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
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
��������
��
��������������������������� !�"#����$%������"��&��'������(�������)*+,-./0123145+*4/623*1474..1-38-,//8*9:$��;<�:�=���'"�������>�"�?@"�@#�'���������>�������AB�CDEFGHIEJGKLGM�NOB�PQ�RDSK�
07.07.2025
Datei
PD