# The Medicines (Products for Human Use — Fees) Regulations 1995, Paragraph 2


Where, at the specific written request of the licensing authority, an application is made for the variation of a marketing authorization so as to—
(a) restrict any one or more of the indications, dosage or target population, or
(b) add a contraindication or a warning or both of these,
as a consequence of new information having a bearing on the safe use of the product, the fee payable under regulation 7(1) shall be refunded or, if it has not yet been paid, shall be waived.

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Source: https://www.legislation.gov.uk/uksi/1995/1116/schedule/5/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-5/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.