Explanatory note
(This note is not part of the Order)
This Order amends the Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989 (“the 1989 Order”) which prescribes the functions and matters which are to be taken into account in fixing fees under the Medicines Act 1971 (“the 1971 Act”). Those fees relate to applications for licences and certificates under Part II of the Medicines Act 1968, the variation, renewal or holding of such licences and inspections relating to them.
Article 2(a) of the Order substitutes a new paragraph for paragraph 4 of the 1989 Order to take account of the disestablishment of—
the Committee on Review of Medicines by the Medicines (Committee on the Review of Medicines) (Revocation) Order 1992 (S.I. 1992/606); and
the Committee on Dental and Surgical Materials by the Medicines (Committee on Dental and Surgical Materials) (Revocation) Order 1994 (S.I. 1994/3120).
Article 2(b) and (c) of this Order extends the 1989 Order so that, in fixing fees under the 1971 Act, account is taken of the functions of the licensing authority under the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144) and of persons appointed under Schedule 2 to those Regulations and of functions relating to the enforcement of those Regulations.