Supplements can be classified as either “food supplements” or “traditional herbal medicines”. Food supplement registration is voluntary, while traditional herbal medicine registration is mandatory. The EU Directive is followed for the former.
In the UK, Directive 2002/46/EC is implemented by the Food Supplements (England) Regulations 2003, with equivalent regulations in Scotland, Wales and Northern Ireland.
“Food supplements” mean foodstuffs, the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in a discrete or measured dosage forms.
A product with active ingredients that are herbal substances and/or herbal preparations (e.g., extraction, distillation, expression) are classified as “traditional herbal medicines”. The Traditional Herbal Medicines Directive (Directive 2004/24/EC) was published on 30 April 2004 and implemented by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005, which for the most part came into force on 30 October 2005 (Part 7 of the Human Medicines Regulations from 14 August 2012).
NHP Consulting will prepare the required regulatory documentation to achieve market compliance for food supplements in the United Kingdom.