# The Medicines (Products for Human Use) (Fees) Regulations 2016, Regulation 19D: Fee for carrying out a major safety review


(1) Where the licensing authority conducts a major safety review of a United Kingdom marketing authorisation or traditional herbal registration, or a set of such marketing authorisations or traditional herbal registrations, under regulation 196 of the Human Medicines Regulations, a fee is payable in accordance with Part 6A of Schedule 2.
(2) Unless paragraph (3) applies, the fee referred to in paragraph (1) is payable by the holder of the marketing authorisation or registration to which the review relates.
(3) Where the review relates to two or more authorisations or registrations the fee referred to in paragraph (1) is to be divided by the number of authorisations or registrations forming part of the review (“relevant authorisation or registration”) and each holder of a relevant authorisation or registration must pay that reduced fee in respect of each relevant authorisation or registration it holds.

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