Joint Committee on Statutory Instruments Fifteenth Report


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 Use—Fees) 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

previous page contents next page

House of Lords home page Parliament home page House of Commons home page search page enquiries index

© Parliamentary copyright 2001
Prepared 21 June 2001