# The Medicines (Products for Human Use) (Fees) Regulations 2012, Paragraph 3: Variation of a traditional herbal registration


Where at the specific written request of the licensing authority, or in response to the imposition of an urgent safety restriction under regulation 8 of the Herbal Regulations, an application is made for the variation of a traditional herbal registration so as to—
(a) restrict any one or more of the indications, dosage or target population; or
(b) add a new 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 18(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/nisr/2012/134/schedule/7/paragraph/3 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-7/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.