Directive 2001/83/EC, as amended by Directive 2004/24/EC, requires each European Union member state to establish a simplified registration scheme for traditional herbal medicinal products. The provisions of Directive 2004/24/EC were transposed into United Kingdom law principally through the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005.
Article 13 of Directive 2001/83/EC, as amended, also requires EU member states to set up a special simplified registration procedure for homeopathic products. Products registered under this long-standing scheme are not permitted to have specific therapeutic indications on their labels. Homeopathic medicinal products in the UK may also be authorised under Article 16, which permits a member state to introduce specific rules for pre-clinical and clinical trials of homeopathic medicinal products in accordance with the principles and characteristics of homeopathy as practised in that member state. Such products may be labelled with a range of strictly limited therapeutic indications. This scheme was introduced to the UK through the Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006.
The European Food Supplements Directive 2002/46/EC sets down requirements for food supplements marketed in the EU. The directive is implemented in England by the Food Supplements (England) Regulations 2003, as amended.
A draft European Commission regulation, intended to effect amendments to the Food Supplements Directive to add vitamin and mineral substances to the list of those permitted for use in food supplements, received a favourable vote at the meeting of the general food law section of the Standing Committee on the Food Chain and Animal Health on 15 July 2009. The draft regulation will now be considered by the European Parliament and European Council.
Work on setting maximum levels for vitamins and minerals in food supplements is ongoing at European level and the timing for finalising any proposals is uncertain.