UK MCA Fees "Down 2% In 1996-97"

The overall effect of changes made to the UK Medicines Control Agency's fees for human-use medicinal products from April 1 has been a reduction of around 2%, says the MCA's current MAIL publication. This has been achieved through adjustments to certain individual fees based on analysis of time recording data, says MAIL, adding that many fees remain at 1995-96 levels.

Late last year, the MCA invited comments on proposals to modify the fee structure (Marketletter December 4, 1995); MAIL says 16 responses were received and all points made have been considered carefully. For 1996-97, certain capitation fees have been reduced by 5%-20%, but, following analysis of the time recording system, the fee for complex abridged applications has gone up 7.5%. Most periodic fees remain at 1994-95 levels, but initial fees for new active substances and complex abridged authorizations have been reduced by 5% and 20% repectively. The periodic fee for Prescription-Only Medicines has gone up 5%.

Fees charged to Notified Bodies in connection with assessments requested for drug-device combinations under the Medical Devices Directive go down 15%.