Scandinavian Regulatory Services

User testing

We perform Readability testing of Patient Leaflets.
The test is performed in accordance with current and appropriate standards, e.g.:

  • EFPIA. General Recommendations for Readability User Testing of Package Leaflets for Medicinal Products for Human Use.
  • MHRA Guidance on the User Testing Patient Information Leaflets.
  • A Guideline on the Readability of the Label and Package leaflet of Medicinal Products for Human Use.

Our readability studies have been used and accepted by Member States in Mutual Recognition and Decentralised Procedures throughout Europe.