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Chapter I Pre-clinical requirements

United Kingdom

Original text. Later amendments are not shown.

Pre-clinical studies are required to establish the pharmacological activity and the tolerance of the product.

  1. APHARMACOLOGY
  2. BTOLERANCE IN THE TARGET ANIMAL SPECIES

Notes on Annex II

Footnotes

f1

This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.