§ Lord Clement-Jones
asked Her Majesty's Government:
To what extent the requirements of European Directive 2001/20/EC, which relate to clinical trials of medicinal products, will be deemed to apply to the human testing of non-medicinal toxic agents. [HL794]
§ Lord Warner
The full title of the Clinical Trials Directive (2001/20/EC) is "Directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use". It applies only to the conduct of clinical trials with medicinal products for human use, and does not apply to the testing of substances which are not medicinal products.