Memorandum by the Department of Health
Medicines for Human Use and Medical Devices
(Fees and Miscellaneous
Amendments) Regulations 2001 (S.I. 2001/795)
1. The Joint Committee on Statutory Instruments has
asked the Department the following question:
Explain the reason for the 30%
increase in the fee for export certificates, referred to in the
penultimate paragraph of the explanatory note.
2. These Regulations include, amongst other amendments,
change to the fees set out in the Medicines (Homoeopathic Medicinal
Products for Human Use) Regulations 1994, the Medical Devices
(Consultation Requirements) (Fees) Regulations 1995 and the Medicines
(Products for Human UseFees) Regulations 1995 (collectively
referred to in this memorandum as "the Amended Regulations").
The changes comprise an average increase of 5% to the fees set
out in the Amended Regulations with the exception of the fee for
export certificates which is increased by 30%.
3. This 30% increase for the fee for export certificates
is well above the level of other increases because of a change
in the style and content of the certificate to comply with WHO
guidelines and the increased cost of producing this new style
certificate. In practice, this means that the fee will be increased
by £11 from £34 to £45 for each set of certificates.
4. The WHO certification scheme for export certificates
was introduced in April 1998. Prior to that date the Medicines
Control Agency (MCA) had operated its own certification scheme.
The introduction of the WHO scheme necessitated a number of changes
which increased the costs associated with issuing certificates:
(i) The WHO certificate
comprises an average of seven pages whereas the previous certificate
was only one page. Furthermore, the WHO certificate also has a
copy of the Summary of Product Characteristics (SPC) which averages
eight pages but can be as many as twenty pages. Stationery and
postage costs alone are significantly higher as a result.
(ii) The WHO certificate is more complex
and requires MCA verification of a significant amount of user
supplied information. Processing time for the new WHO applications
is much longer than previously. Time recording data indicates
this to be over 30% more. Additional staff resources of 40% have
been provided to the export certificates section to deal with
the additional work.
6 April 2001