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Scandinavian Regulatory Services

User testing

We perform Readability testing of Patient Leaflets.
- The test is performed in accordance with:

•EFPIA. General Recommendations for Readability User Testing of Package Leaflets for Medicinal Products for Human Use – Version March 2003.
•MHRA Guidance on the User Testing Patient Information Leaflets- Version June 2005.
•A Guideline on the Readability of the Label and Package leaflet of Medicinal Products for Human Use (European Commission, January 2009).


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

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