# 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 2.7: Clinical Summary

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

A detailed, factual summary of the clinical information on the medicinal product included in Module 5 shall be provided. This shall include the results of all bio-pharmaceutics studies, of clinical pharmacology studies, and of clinical efficacy and safety studies. A synopsis of the individual studies is required.
Summarised clinical information shall be presented in the following order:
Summary of Bio-pharmaceutics and Associated Analytical Methods
Summary of Clinical Pharmacology Studies
Summary of Clinical Efficacy
Summary of Clinical Safety
Synopses of Individual Studies

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/2/division/2.7 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-2/division-2.7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.