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Version 110.3, 09/2022
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
[NOTE: the following are those items of informatio
15.04.2025
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Feasibility and value of a
possible “key information
section” in patient information
leaflets and summaries of
product characteristics of
medicinal products for human
use
The PILS-BOX stu
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1
Consultation on a potential Key Information
Section in the Package Leaflet of centrally
authorised medicinal products
Fields marked with * are mandatory.
Introduction
Background
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WF Neu I 2025:
Beschlussvorlage des BfArM
zu den Anträgen zu neuen Messzahlen
im Rahmen der Allgemeinen Verwaltungsvorschrift
auf Basis der Empfehlungen des BfArM vom
28.02.2025
und
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koenig
Hervorheben
koenig
Hervorheben
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TEAM-NB Ref.: Press-Release-TEAM-NB-COVID-test-classification-change-20250404.docx Page 1/3
The European Association of
Medical devices Notified Bodies
TEAM-NB A.I.S.B.L.
Rue Bawepuce 20
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Page 1 of 16
Team NB-IVDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
Editor: Team-NB Adoption date 09/04/2025 Ver
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The European Association of
Medical devices Notified Bodies
Team-NB Position Paper
TEAM-NB Ref.: Team-NB-PositionPaper-EU-AI-Act-V2-20250409.docx Page 1/9
Editor: Team-NB Adoption da
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The European Association of
Medical devices Notified Bodies
Team-NB Position Paper
TEAM-NB Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V3-20250409.docx Page 1/79
Editor: Team-N
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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 Deutschlan
15.04.2025
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