# 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 4.1: Format and Presentation

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

The general outline of Module 4 is as follows:
Table of contents
Study reports
Pharmacology
Primary Pharmaco-dynamics
Secondary Pharmaco-dynamics
Safety Pharmacology
Pharmaco-dynamic Interactions
Pharmaco-kinetics
Analytical Methods and Validation Reports
Absorption
Distribution
Metabolism
Excretion
Pharmaco-kinetic Interactions (non-clinical)
Other Pharmaco-kinetic Studies
Toxicology
Single-Dose Toxicity
Repeat-Dose Toxicity
Genotoxicity
In vitro
In vivo (including supportive toxico-kinetics evaluations)
Carcinogenicity
Long-term studies
Short- or medium-term studies
Other studies
Reproductive and Developmental Toxicity
Fertility and early embryonic development
Embryo-fetal development
Prenatal and postnatal development
Studies in which the offspring (juvenile animals) are dosed and/or further evaluated
Local Tolerance
Other Toxicity Studies
Antigenicity
Immuno-toxicity
Mechanistic studies
Dependence
Metabolites
Impurities
Other
Literature references

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/4/division/4.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-4/division-4.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.