Compliance with the summary of product characteristics (SPC) is no longer part of the UK Medicines and Healthcare products Regulatory Agency (MHRA) assessment procedure for patient information leaflets (PIL) which are accompanied by data showing they are compliant with new European Union (EU) regulation.

By July 1, all products must, legally, have an updated marketing authorization (MA) with an approved PIL to comply with the new legislation but, by the beginning of April, a “significant minority” of firms had failed to submit applications, and enforcement action may be necessary, the MHRA has warned. It had hoped to avoid a peak of work in the run-up to the deadline, both for itself and for industry but, despite a three-year transition period and guidance calling for submissions by the end of December 2007 at the latest, there is now a significant risk that compliance action will need to be taken, it says.

To deal with the large volume of applications now in the system and the timeframe for compliance, the MHRA has made other changes to the procedure. For example, it says that assessment will now be focused on key areas of PILs to ensure that key messages for safe use, in line with current clinical practice, are included and displayed prominently, while the time to assessment will be prioritised according to known variables, eg, particular test houses, companies or products. Assessors are working in therapeutic areas, to make best use of their experience, it adds.

The agency says it has 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,” it goes on, pointing that this, in any case, is the responsibility of the MA holder.

- The new EU legislation appears in articles 59(1) [information to be shown] and 59(3) [consultation with target patient groups] of Council Directive 2001/83/EC.