OpenLegislation

Division 2.6 Non-clinical summaryF1

United Kingdom

Original text. Later amendments are not shown.

The results of pharmacology, pharmaco-kinetics and toxicology studies carried out in animals/in vitro shall be provided as factual written and tabulated summaries which shall be presented in the following order:

  • Introduction

  • Pharmacology Written Summary

  • Pharmacology Tabulated Summary

  • Pharmaco-kinetics Written Summary

  • Pharmaco-kinetics Tabulated Summary

  • Toxicology Written Summary

  • Toxicology Tabulated Summary.

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).