Spain

Policy

Spain does not have national policies, laws or regulations regarding use and practice of TM/CAM and to date, there are none expected to be developed.

Contact

Ministry of Health and Consumption                   

Website: http://www.msc.es/

 

Ministry of Agriculture, Fisheries and Food                             

Website: http://www.mapa.es/

 

Laws & Regulations

Food supplements are unregulated and do not require notification or authorization.

Herbs - There is a positive list of herbs considered salable as food.  Most botanical supplements made up of a single herbal ingredient are classified as medicines.  Some supplements comprised of a botanical and nutrient combination are classified as foods.  There is a larger list of traditional herbs that do not require registration so long as they are used singularly and not in extract form.  For combinations of traditional herbs there is a simplified pharmaceutical registration process so long as the herbs are in a whole form.  Other botanical supplements must undergo a full pharmaceutical registration process.  The Royal Spanish Pharmacopoeia is considered legally binding.  GMP's are the same as for conventional drugs.

Fortified and functional foods are only allowable in very specific cases.  Most fortified and functional foods cannot be sold in Spain.  Food with added botanicals are unregulated and do not require notification or authorization.

A post-market surveillance program exists that is the same as that used for conventional drugs.

Spain does not have national policies, laws or regulations regarding use and practice of TM/CAM and to date, there are none expected to be developed.

Contact

Ministry of Health and Consumption                   

Website: http://www.msc.es/

 

Ministry of Agriculture, Fisheries and Food                             

Website: http://www.mapa.es/