Principles and Practice of Pharmaceutical Medicine

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:

1. Any medicinal product prepared in a pharmacy
   in accordance with a medical prescription for an
   individual patient (commonly known as the
   magistral formula).


2. 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).

3. Medicinal products intended for research and
   development trials, but without prejudice to the
   provisions of Directive 2001/20/EC.


4. Intermediate products intended for further pro-
   cessing by an authorized manufacturer.


5. Any radionuclides in the form of sealed sources.


6. 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