Patient information leaflets for medicines: Information for marketing authorisation holders

Changes to the assessment process in the Patient Information Quality Unit - April 2008
In the light of the large volume of applications currently in the system and the timeframe for compliance of all marketing authorisations, changes to the assessment procedure for patient information leaflets accompanied by data demonstrating compliance with article 59(3) of Council Directive 2001/83/EC [user testing] have been put in place. These are set out below:

• Assessment is focussed on key areas of the leaflet to ensure that key messages for safe use in line with current clinical practice are included and displayed prominently.
• Assessors are working in therapeutic areas to make best use of assessor experience.
• Compliance with the summary of product characteristics (SPC) is no longer part of the assessment process.
• The time to assessment will be prioritised according to known variables (particular test houses, companies or products).

We have taken a risk-based approach to these changes. Focussing assessment on key safety issues ensures that the most important elements of safe use are prioritised. We have analysed the value of the SPC compliance check and determined that few checks result in compliance issues and those that do, do not impact on safety or raise public health issues (this is, in any case, the responsibility of the marketing authorisation holder rather than the MHRA).

Where key information is not included in the proposed patient information leaflet because it does not appear in the summary of product characteristics, applicants should consider what variation applications should be made subsequently in order to ensure the SPC reflects current clinical knowledge.

Compliance with legal requirements on consultation with target patient groups: 30 June 2008 deadline for applications
A reminder was sent to all marketing authorisation holders to submit applications to update marketing authorisations (MAs) with an approved patient information leaflet to comply with the new legal requirements in articles 59(1) [information to be shown] and 59(3) [consultation with target patient groups] of Council Directive 2001/83/EC. It is a legal requirement that all products have an updated MA by 1 July 2008.