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Paragraph 3 Variation of a traditional herbal registration

Original text. Later amendments are not shown.

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.