OpenLegislation

Division CHAPTER III: PARTICULARS AND DOCUMENTSF1

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

Annotations

Textual amendments

F1

Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance).