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Division PART 4: PRE-CLINICAL AND CLINICAL TRIALF1

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. CHAPTER I:PRE-CLINICAL REQUIREMENTS
  2. CHAPTER II:CLINICAL REQUIREMENTS
  3. CHAPTER III:PARTICULARS AND DOCUMENTS

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).