Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (c. 83)

[F1ANNEX I U.K. ANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS

Textual Amendments

F1 Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance).

PART I U.K. STANDARDISED MARKETING AUTHORISATION DOSSIER REQUIREMENTS

5. MODULE 5: CLINICAL STUDY REPORTS U.K.

5.1. Format and Presentation U.K.

The general outline of Module 5 is as follows:

Table of contents for clinical study reports
Tabular listing of all clinical studies
Clinical study reports
- Reports of Bio-pharmaceutical Studies
  - Bio-availability Study Reports
  - Comparative Bio-availability and Bio-equivalence Study Reports
  - In vitro — In vivo Correlation Study Report
  - Reports of Bio-analytical and Analytical Methods
- Reports of Studies Pertinent to Pharmaco-kinetics Using Human Bio-materials
  - Plasma Protein Binding Study Reports
  - Reports of Hepatic Metabolism and Interaction Studies
  - Reports of Studies Using Other Human Bio-materials
- Reports of Human Pharmaco-kinetic Studies
  - Healthy subjects Pharmaco-kinetics and Initial Tolerability Study Reports
  - Patient Pharmaco-kinetics and Initial Tolerability Study Reports
  - Intrinsic Factor Pharmaco-kinetics Study Reports
  - Extrinsic Factor Pharmaco-kinetics Study Reports
  - Population Pharmaco-kinetics Study Reports
- Reports of Human Pharmaco-dynamic Studies
  - Healthy Subject Pharmaco-dynamic and Pharmaco-kinetics/Pharmaco-dynamic Study Reports
  - Patient Pharmaco-dynamic and Pharmaco-kinetics/Pharmaco-dynamic Studies Study Reports
- Reports of Efficacy and Safety Studies
  - Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
  - Study Reports of Uncontrolled Clinical Studies
  - Reports of Analyses of Data from More than One Study including any formal integrated analyses, meta-analyses and bridging analyses
  - Other Study Reports
- Reports of Post-marketing Experience
Literature references]