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.