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The Medicines (Products for Human Use) (Fees) Regulations 2012
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Variation of a traditional herbal registration
3. 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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