The Pharmaceutical Journal
Vol 275 No 7356 p5
2 July 2005

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News summary

PIL user testing mandatory

Guidance on user testing of patient information leaflets was published by the Medicines and Healthcare products Regulatory Agency this week.

User testing of PILs became mandatory on 1 July following a review of European Medicines legislation in 2001. The guidance is aimed at marketing authorisation holders, who will now have to submit the results of user testing of PILs to the MHRA with all marketing authorisation applications for new drugs. By 2008 all PILs will need to have been tested on potential users.

The guidance describes how and when to apply a user test, provides an illustration of one way to undertake user testing and offers advice on who should be involved in the process. The guidance is available via PJ Online (www.pjonline.com/links/pj).
News feature, p12