These new performance measures are intended to provide guidance to marketing authorisation holders on workload in the Patient Information Quality Unit (PIQU). This follows feedback from the medicines trades associations that separate metrics were required to enable planning for companies. The data will be updated monthly.
Quarterly data for 2004 - 2009
These figures represent the number of submissions under Article 61(3) of Council Directive 2001/83/EC received by the MHRA per financial quarter beginning April 2004 and ending June 2009.
The data represent actual quarterly data. Prior to July 2005, the average number of Article 61(3) submissions received was 1500 to 1600 per annum.
The data indicate that the number of submissions did not increase significantly from the baseline level until the quarter ending December 2007, which was when the MHRA had expected to receive all leaflet submissions with supporting user test data in respect of compliance with the new legal provisions set out in Article 59(3). In the subsequent six months to 30 June 2008 deadline for compliance with this new provision, the MHRA received the equivalent of nearly five years' work compared to baseline.
The data also indicate that there is a decreasing trend in the number of submissions such that they now appear to be returning to the previous baseline level.
NB. These data do not include the 1,100 Mutual Recognition Procedure (MRP) patient information leaflet harmonisation variations (with appropriate supporting user test data) which have been assessed to date by the Patient Information Quality Unit or the other 3,400 BROMI self-certification Article 61(3) notifications submitted to date.
The data for July to December 2005 do not accurately reflect the MHRA workload since during this period the submission data were migrated from the former ‘PLUS’ system to its replacement ‘Sentinel’ and a processing backlog developed.
Article 61(3) submissions to MHRA April 2004 onwards
(13Kb)
Cumulative Article 61(3) notifications to MHRA April 2004 onwards (13Kb)
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Monthly data on applications handled by PIQU from July 2010 until March 2011
These figures represent the actual monthly numbers of applications submitted under article 61(3) of Council Directive 2001/83/EC handled by the Patient Information Quality Unit from July 2010 until March 2011.
Data include actual numbers of applications received, assessed and determined in each monthly period. Data show that the PIQU are continuing to assess and determine a greater number of applications than those received as the large influx of work received in 2008 moves through the assessment area.
Applications to the Patient Information Quality Unit (PIQU) per month (13Kb)
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