OpenLegislation

Part 4 Pre-clinical and clinical trial

United Kingdom

Original text. Later amendments are not shown.

The particulars and documents, which shall accompany applications for marketing authorisations pursuant to the third indent of Article 12(3)(j) shall be submitted in accordance with the requirements below.

  1. IPre-clinical requirements
  2. IIClinical requirements
  3. IIIParticulars and documents

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.