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The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023
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- UK Statutory Instruments
- 2023 No. 377
- PART 2
- Regulation 14
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New regulation 56B
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14. After regulation 56A (fees in connection with approval of coronavirus test devices), insert—
“Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
56B.—(1) Subject to paragraph (2), the fee payable by an approved body in respect of a consultation or further consultation with the Secretary of State in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device is the fee specified in regulation 56C.
(2) No fee is payable if it is the first time the Secretary of State has been consulted by any approved body in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device if the medicinal substance is an authorised medicinal product.”.
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