OpenLegislation

Division 2.7 Clinical SummaryF1

United Kingdom

Original text. Later amendments are not shown.

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

Annotations

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).