Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
In the last 12 months the Patient Information Quality Unit (PIQU) has received a huge volume of applications for approval of user tested patient information, amounting to around the number the Unit would usually deal with in six years. In total, some 10,000 applications have been received and 8,000 assessed in little over one year. All applications received by 31 December 2007 were assessed before the June deadline, and 97% of applications received by the deadline were assessed within 90 days. We are working to clear the peak of applications received after the deadline and once this has been achieved, hope to reduce patient information leaflet (PIL) clearance times to well under the 90 day application timetable.
Profile of submissions to MHRA
The deadline for compliance with Article 59 (3) of Council Directive 2001/83/EC (consultation with target patient groups) was 30 June 2008. Despite a three year transition period following consultation and a call for submissions by the end of December 2007, relatively few applications had been made. By 1 January 2008 less than 2000 user testing applications had been received. From the beginning of 2008 until the end of June deadline a further 5,000 applications were made, and from the deadline to the beginning of November 2,500 applications have been made. In all, 25% of all applications were received after 30 June deadline.
Encouraging compliance
In addition to communications though the MHRA website, a letter was sent to all marketing authorisation (MA) holders (dated 2 April 2008) as a reminder of the deadline, providing advice on how to submit approvable applications and reiterating the alternative requirement to submit a notification that the product will not be marketed if they were to be considered compliant.
Enforcement action
As the deadline of 30 June passed, the Agency sought to identify MAs which had not been the subject of an application or a notification of non-marketing. More than 4,500 MAs were identified and letters were sent to 268 MA holders in September/October instructing them to submit within 14 days in order to avoid enforcement action. The Agency is still following up some of these letters but from those responses received, the large majority (over 60%) are not marketed, and the MAH had not submitted a notification. A sizeable number (around 10%) had applications made after the end June deadline. A number of companies have now provided plans for submission. We are following up those MAs which continue to appear to be non-compliant.
Apology
A small minority of MAs (around 5% of the total) were incorrectly included in the letters for various reasons relating to how data had been held and updated. We are very sorry about those cases where these issues have resulted in inaccurate letters to MA holders and apologise for any concern caused. We would like to assure companies involved that steps have been taken to address these issues and we are grateful for your co-operation and patience during highly unusual circumstances.
