OpenLegislation

Division 5.2.5 Reports of efficacy and safety studiesF1

United Kingdom

Original text. Later amendments are not shown.

  1. 5.2.5.1Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
  2. 5.2.5.2Study reports of uncontrolled clinical studies reports of analyses of data from more than one study and other 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).