OpenLegislation

Part I STANDARDISED MARKETING AUTHORISATION DOSSIER REQUIREMENTSF1

United Kingdom

Original text. Later amendments are not shown.

  1. 1MODULE 1: ADMINISTRATIVE INFORMATION
  2. 2MODULE 2: SUMMARIES
  3. 3MODULE 3: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL INFORMATION FOR MEDICINAL PRODUCTS CONTAINING CHEMICAL AND/OR BIOLOGICAL ACTIVE SUBSTANCES
  4. 4MODULE 4: NON-CLINICAL REPORTS
  5. 5MODULE 5: CLINICAL STUDY REPORTS

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).