Sweden

Policy

There is presently no national policy, program or regulations regarding practice of TM/CAM and there are no plans for development in this area.

Contact

Swedish National Food Administration                   
Website: http://katalogen.sunet.se

 

Laws & Regulations

There is no notification system for food supplements.  The Swedish National Food Administration uses its draft rules on vitamins and minerals for regulation.

Supplements containing botanicals are either classified as natural remedies or pharmaceuticals and must be registered with the Medical Products agency.  Natural remedies containing traditional herbs may be registered through a simplified pharmaceutical registration process.  There are presently over 2,275 registered herbal medicines, though none of these appear on an essential drug list.

Fortified and Functional Foods - The National Food Administration's regulation on food enrichment of 1983 allows some foods to be fortified with specific nutrients without authorization.  Other foods and nutrients require individual authorization.  The fortification of foods that are non-nutritional is usually not allowed.  Foods with added botanicals are unregulated and do not require notification or authorization.  Botanicals considered foods may be added to foods so long as they are safe.

The post-market surveillance program that covers adverse events for all drugs now carries a special category of herbal remedies.

There is presently no national policy, program or regulations regarding practice of TM/CAM and there are no plans for development in this area.

Contact

Swedish National Food Administration                  

http://katalogen.sunet.se/reginfo.html?id=4347&lang=englishl.