# The Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989, Paragraph 2: Fees


Subject to paragraphs 3 to 5 below, the fee payable in respect of an inspection under these Regulations shall be —
(a) except in the case of an inspection falling within sub-paragraphs (b) to (d) below —
(i) in respect of a minor inspection, £750;
(ii) in respect of a standard inspection, £1,500;
(iii) in respect of a major inspection, £3,000;
(b) where the site inspected is wholly or partly concerned with the manufacture of sterile products or the filling of the containers directly in contact with such products —
(i) in respect of a minor inspection, £1,250;
(ii) in respect of a standard inspection, £2,500;
(iii) in respect of a major inspection, £5,000;
(c) except in the case of an inspection falling within sub-paragraph (b) above or sub-paragraph (d) below, where the site inspected is concerned only with the assembly of medicinal products —
(i) in respect of a minor inspection, £500;
(ii) in respect of a standard inspection, £1,000;
(iii) in respect of a major inspection, £2,000;
(d) where the site inspected is limited solely to the manufacture or assembly of medicinal products, the sale or supply of which does not require a product licence and to which Article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies, £50.

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Source: https://www.legislation.gov.uk/uksi/1989/418/schedule/2/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-regulations-1989/schedule-2/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.