# The Medicines (Products for Human Use) (Fees) Regulations 2016, Regulation 19E: Fee for assessment of periodic safety update reports


(1) This regulation applies where—
(a) a periodic safety update report has been submitted to the licensing authority under regulation 191 or 192 of the Human Medicines Regulations; and
(b) that periodic safety update report relates to a medicinal product which has a UK reference date within the meaning of regulation 193 of the Human Medicines Regulations.
(2) Where this regulation applies, the fee payable by the holder of a marketing authorisation or traditional herbal registration to which the periodic safety update report relates is—
(a) £1,066, in the case where no other periodic safety update reports relating to medicinal products with the same UK reference date are submitted; and
(b) £534, in any other case.

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