To ask the Secretary of State for Health whether the targets for granting marketing authorisations detailed in the Medicines and Healthcare Products Regulatory Agency's business plan for 2005 are being met for over-the-counter medicines; and how many application files were open on the last date for which figures are available.
holding answer
In the published business plan for the Medicines and Healthcare products Regulatory Agency (MHRA) for 2005–06, assessment time targets are given for various types of licensing work, including variations to licences and new licences based on abridged dossiers. Specific targets are not given for over-the-counter medicines because these would be included with the abridged dossier applications.
On
I am aware that the MHRA's performance regarding licence and variation approval times during the last nine months has been affected by a combination of adverse factors, including increases in work load, difficulties in recruiting professional assessment staff, especially medically-qualified staff, and transitional implementation problems during the introduction of a new information management system. Though statistics for the full year 2005–06 are not yet available, it is likely that some of the target assessment times given in the plan will not be met.
The MHRA is taking a number of steps to improve service levels. These include organisational restructuring, additional recruitment, re-training of staff, voluntary schemes for extended working hours, and information system performance enhancements.
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