human use intended to be placed on the market in
MS and either prepared industrially or manufac-
tured by a method involving an industrial process’,
whereas, according to article 3, the following
products are not included in the scopes of the
Directive:
- Any medicinal product prepared in a pharmacy
in accordance with a medical prescription for an
individual patient (commonly known as the
magistral formula). - Any medicinal product which is prepared in a
pharmacy in accordancewith the prescription of
a pharmacopoeia and is intended to be supplied
directly to the patients served by the pharmacy
in question (commonly known as the officinal
formula).
- Medicinal products intended for research and
development trials, but without prejudice to the
provisions of Directive 2001/20/EC. - Intermediate products intended for further pro-
cessing by an authorized manufacturer. - Any radionuclides in the form of sealed sources.
- Whole blood, plasma or blood cells of human
origin.
Module I
Regional
Administrative
Information
1
1.1 Submission
Table of Content
CTD Table of Contents
2.1
CTD Introduction
2.2
Module 3
Quality
3
3.1 Table of Content
Module 4
Nonclinical
study reports
4
4.1 Table of Content
Module 5
Clinical
study reports
5
5.1 Table of Content
Quality
Overall
Summary
2.3
Clinical
Overview
2.5
Clinical
Summary
2.7
Nonclinical
Overview
2.4
Nonclinical written
and tabulated
Summaries
2.6
Not part of the CTD
CTD
Module II
Figure 34.2 The organization of the ICH common technical document (CTD)
456 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION