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Product information

Apart from documentation concerning quality, efficacy and safety a natural remedy must also have approved product information:

  • Summary of Product Characteristics (SPC)
  • Product Information Leaflet (PIL)
  • Labelling

SPC and PIL must be designed according to the Medical Products Agency’s templates.

Please refer to the Medical Product Agency Codes of statutes, LVFS 1995:14 and LVFS 2005:11 for regulations concerning product information.

 
 
 
Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | phone: +46 18 174600, fax: +46 18 548566 | Contact information