OpenLegislation

Division 1.1 Plasma-derived medicinal productF1

United Kingdom

Original text. Later amendments are not shown.

For medicinal products derived from human blood or plasma and by derogation from the provisions of Module 3, the dossier requirements mentioned in ‘ Information related to the starting and raw materials ’ , for starting materials made of human blood/plasma may be replaced by a Plasma Master File certified in accordance with this Part.

  1. a)Principles
  2. b)Content
  3. c)Evaluation and Certification

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).