OpenLegislation

Chapter III Particulars and documents

United Kingdom

Original text. Later amendments are not shown.

The dossier on efficacy shall include all pre-clinical and clinical documentation and/or results of trials, whether favourable or unfavourable to the veterinary medicinal products, in order to enable an objective overall assessment of the risk/benefit balance of the product.

  1. 1Results of pre-clinical trials
  2. 2Results of clinical trials

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.