OpenLegislation

Annex I ANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTSF1

United Kingdom

Original text. Later amendments are not shown.

  1. Introduction and general principles
  2. ISTANDARDISED MARKETING AUTHORISATION DOSSIER REQUIREMENTS
  3. IISPECIFIC MARKETING AUTHORISATION DOSSIERS AND REQUIREMENTS
  4. IIIPARTICULAR MEDICINAL PRODUCTS
  5. IVADVANCED THERAPY MEDICINAL PRODUCTS

Annotations

Textual amendments

F1

Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance).