# The Medicines (Products for Human Use) (Fees) Regulations 2016, Regulation 19A: Fees for certification of plasma master files


(1) The fee payable by a person who submits a plasma master file to the licensing authority for scientific and technical evaluation in accordance with paragraph 1.1(c), second indent, of Part III of Annex I to the 2001 Directive, is £11,126.
(2) The fee payable by a person who submits a plasma master file to the licensing authority for re-certification in accordance with paragraph 1.1(c), third indent, of Part III of Annex I to the 2001 Directive is—
(a) £419, where there are no changes to the plasma master file other than an update to epidemiological data; or
(b) £1,593, in any other case.

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Source: https://www.legislation.gov.uk/uksi/2016/190/regulation/19A (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.