# The Medicines (Products for Human Use — Fees) Regulations 1991, Paragraph 1: Product licences


Subject to paragraphs 2, 3, 4 and 5, the fee payable under regulation 4(a) in connection with an application for a product licence of a kind described in Column 1 of the following Table shall be the fee specified in the corresponding entry in Column 2 of that Table:
TABLE
Column 1
Column 2
Kind of Application
Fee Payable
1 Major application
(a) in respect of any such application—
1 (a) £17,000
(i) to which paragraph 5 of Chapter III of Part 3 of the Annex to Council Directive 75/318/ EEC applies; or
(ii) which relates to an article or substance in relation to which Part II of the Act has effect by virtue of an order made under section 104 or 105(1)(a) of the Act;
(b) in any other case
1 (b) £92,000
2 Complex application
2 £17,000
3 Standard application
3 £7,000
4 Simple application
4 £2,000
5 Application for a product licence (parallel import)
5 £1,750

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Source: https://www.legislation.gov.uk/uksi/1991/1474/schedule/1/part/II/paragraph/1 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1991/schedule-1/part-II/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.