OpenLegislation

Division 1.2 VaccinesF1

United Kingdom

Original text. Later amendments are not shown.

For vaccines for human use and by derogation from the provisions of Module 3 on ‘ Active substance(s) ’ , the following requirements when based on the use of a Vaccine Antigen Master File system shall apply.

The marketing authorisation application dossier of a vaccine other than human influenza vaccine, shall be required to include a Vaccine Antigen Master File for every vaccine antigen that is an active substance of this vaccine.

  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).