Unlicensed herbal remedies: finished, manufactured and over-the-counter products

Most manufactured, finished, over-the-counter (OTC) herbal remedies, like the ones available in high street health food stores or super markets, are supplied as unlicensed herbal remedies through Section 12(2) of the Medicines Act 1968.

Specific exemption conditions
Herbal remedies placed on the market through Section 12(2) of the Medicines Act must:

  • be made from only herbal active ingredients. The inclusion of vitamins, minerals, animal derivatives or any other non-herbal active ingredient are not permitted;
  • make no medicinal claims or recommendations for use;
  • hold no brand names. The remedy can only be sold or supplied under a designation which only specifies the plant or plants and the process by which it was made, for example, Echinacea extract; 
  • comply with any restrictions on specific herbal ingredients.

Problems with the current regime
Section 12(2) does not require herbal remedies supplied under it to meet any specific standards of safety or quality. Also, there is no requirement for these products to be accompanied by the necessary information for their safe use, such as safety warnings.  A number of safety concerns (highlighted in our 'Herbal Safety News' section) have a arisen as a result.

As a result, it is the Government’s intention that Section 12(2) of the Medicines Act 1968, following a transitional period (see below) will cease to provide a regulatory route by which manufactured OTC herbal remedies can reach the market place.

Eligibility
It is intended that Section 12(2) of the Medicines Act will ultimately be replaced by the Traditional herbal Medicines Registration Scheme, which was introduced on 30 October 2005

Transitional arrangements for the new scheme mean that if your product was on the market on 30 April 2004 you have until 30 April 2011 to ensure your product complies with the requirements of the new scheme. However, if your product was placed on the market after 30 April 2004, you will not be permitted to place any further supplies of that product on the UK market until the product meets the requirements of the new scheme. The Agency has produced a guidance note, 'MHRA guidance on provisions of the Directive that will determine dates of introduction', on the transitional arrangements for the Traditional Herbal Medicines Registration Scheme.

Contacts for further information
For further information on Section 12(2) of the Medicines Act 1968 or general enquiries about the Traditional Herbal Medicines Registration Scheme contact Judith Thompson: judith.m.thompson@mhra.gsi.gov.uk, telephone 020 3080 6945.


Page last modified: 30 October 2005