UK MCA Proposes Changes To Fee Levels

The UK Medicines Control Agency has announced proposals to cut capital fee levels relating to human-use medicines, and adds that periodic fees for 1995-96 will remain at 1994-95 levels. The Agency also says that it will be able to absorb, without extra fees, the cost of certain additional work expected to arise from the new European Union licensing arrangements. The MCA points out that in 1993-94 and 1994-95 it kept overall fees at 1992-93 levels.

Following an analysis of its time recording system, the MCA plans to reduce capital fees relating to applications for all types of licenses, variations, inspections, etc and for the registration of homeopathic medicines by 5%. This analysis also suggests that some specific capital fees could be cut still further. To this end, it plans to cut application fees for a product license containing a new active substance by a total of 15% to L71,950 ($112.601), and for parallel imports by 15% to L1,700, and fees for change of ownership applications and renewals of Clinical Trial Certificates by 25% (subject to all fees being rounded to convenient whole numbers). Although the analysis suggests that certain other fees are too low, the MCA does not plan to adjust these at present.

New Type Of Capital fee The agency also proposes to introduce a new type of capital fee to cover certain work relating to the EU decentralized licensing scheme covering applications in the UK for which marketing authorizations (ie product licenses) have already been granted in another EU member state, and for which recognition by the UK licensing authority is sought. These fees are to be set initially at 70% of the equivalent national fee. The MCA says it does not for now propose to introduce an increase over and above the equivalent national application fee to cover the extra work to be done to assist in the recognition elsewhere in the EU of a UK marketing authorization; the fees for work in connection with the decentralized licensing system will have to be reviewed in the light of experience.