OpenLegislation

Division 20.4

United Kingdom

Original text. Later amendments are not shown.

‘Legislation satisfying Union requirements’ also includes any international requirement, which at the same time satisfies Union requirements (such as testing to ICHf1, VICHf2, OECD guidelines, European Pharmacopoeia monographs).

Annotations

Footnotes

f1

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

f2

The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products