Product information

Templates for product information and guidelines on summary of product characteristics can be found on the EMA website. Guideline to the Medical Products Agency’s provisions (LVFS 2005:11) on labelling and package leaflets for medicinal products can be found on the MPA website.

The MPA's provisions (LVFS 2006:11) for approval of marketing authorisation for medicinal products regulates the design of the SmPC. The MPA's provisions (LVFS 2005:11) on labelling and package leaflets for medicinal products should be applied regarding the design of package leaflets and packaging materials.

For updating the product information in accordance with the new QRD template, a variation application type 1B (Class C.I.z in accordance with 2010 / C 17/01) should be sent to the MPA.

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information