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The Branded Health Service Medicines (Costs) Regulations 2018
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- UK Statutory Instruments
- 2018 No. 345
- PART 3
- Regulation 20
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Small manufacturer or supplierU.K.
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20.—(1) A small manufacturer or supplier must record and keep the information required under Schedule 2 and provide that information to the Secretary of State in accordance with Schedule 2.
(2) Where a manufacturer or supplier has provided information in accordance with paragraphs 4 or 5 of Schedule 2, the Secretary of State may, for the purposes of verifying the information provided, request the manufacturer or supplier to provide that information in an audited form.
(3) A request under paragraph (2)—
(a)must be made within 12 months of receipt of the information provided in accordance with paragraphs 4 or 5 of Schedule 2;
(b)must require the audited sales report to be provided within a period of not less than 3 months and not more than 12 months of the date on which the Secretary of State made the request; and
(c)must not require the audited sales report to be provided before the completion of the first 9 months following the last day of the manufacturer's or supplier's financial year.
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