EU: Traditional Herbal Medicinal Products Directive

Earl Howe
asked Her Majesty's Government:

Whether manufacturers of products registered under the Traditional Herbal Medicinal Products Directive will be able to indicate on the label whether the products comply with organic standards of production; and, if not, what steps they will take to ensure that consumers of products registered under the directive are able to identify whether they comply with organic standards of production.[HL6840]

The Minister of State, Department of Health (Lord Warner)
Article 62 of Directive 2001/83/EC provides that, in addition to other mandatory information, the outer packaging and the package leaflet of a medicinal product covered by the requirements of the directive may include other information compatible with the summary of product characteristics which is useful for the patient, to the exclusion of any element of a promotional nature. The Medicines and Healthcare products Regulatory Agency is investigating the issue raised and in particular whether there are circumstances in which references to organic production could be compatible with the summary of product characteristics.

[The following Written Answer should have been printed on 14 July 2006]