OpenLegislation

Division Module 3F1

United Kingdom

Original text. Later amendments are not shown.

The provisions of Module 3, including compliance with monograph(s) of the European Pharmacopoeia, shall apply to the authorisation of herbal medicinal products. The state of scientific knowledge at the time when the application is lodged shall be taken into account.

The following aspects specific to herbal medicinal products shall be considered:

  1. (1)Herbal substances and herbal preparations
  2. (2)Herbal 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).