United Kingdom

Policy

Policy to oversee use and practice of TM/CAM is under development by the Medicines and Healthcare Products Regulatory Agency and the Department of Health.  These agencies are assisted by the Prince of Wales Foundation for Integrated Health.  Research into the use of TM/CAM is under the auspices of the Department of Health.

Contact

Medicines and Healthcare Products Regulatory Agency 
Website: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=5 
 
United Kingdom Department of Health
Website: http://www.dh.gov.uk/Home/fs/en

 

Laws & Regulations

Food supplements are not regulated if they are safe and make no medicinal claims.  Foreign companies importing products into the UK bear full responsibility for their safety.  The Medicinal Control Agency reviews products considered to be borderline to determine if their claims or ingredients qualify as medicinal.

Most herbal supplements are not regulated if they are known to be safe, not considered medicinal and make no medicinal claims.   Products considered medicinal must undergo a full pharmaceutical process unless a similar product has already been through that process, at which point an abridged pharmaceutical process is possible. There is no simplified pharmaceutical registration process for new botanical products considered medicinal. However, herbal medicines may bypass the registration and notification process so long as they don't carry an expressive trade name, make neither claims nor recommendations, and are not indicated to be food supplements. More than one botanical may be used in combination in unlicensed herbal medicines; however they may not contain non-herbal ingredients.  There is a negative list of botanicals not permitted in unlicensed herbal medicines and food supplements. The British Pharmacopoeia is legally binding.

Fortified and functional foods are generally not regulated so long as they are considered safe and comply with the Food Safety Act of 1990.  This is inclusive of foods with added botanicals.

A post-marketing surveillance program which covers adverse events has been expanded to cover both botanical medicines and botanical supplements.

Legal guidelines for regulation of chiropractic and osteopathic practices are in place under the Osteopaths Act of 1993 and the Chiropractors Act of 1994.

A traditional herbal registration (THR) must be applied before market any herbal medicines in the UK. However, a THR is only approved if the medicine is used to treat minor health conditions where medical supervision is not required such as cold. If the herbal medicine is used for major health condition, a marketing authorisation must be applied before placing it on the market. 

Contact

Medicines and Healthcare Products Regulatory Agency
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=5
 
United Kingdom Department of Health
http://www.dh.gov.uk/Home/fs/en