# 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, Division 5.1: Format and Presentation

Extent: E+W+S+N.I.

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

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/5/division/5.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-5/division-5.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.