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The Branded Health Service Medicines (Costs) Regulations 2018

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Penalties, demands and appeals

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26.—(1) If the Secretary of State considers that the information provided by a manufacturer or supplier under this Part is incomplete, he may write to the manufacturer or supplier, and where appropriate by giving an information notice, to request complete information from the manufacturer or supplier be provided within a period of 30 days.

(2) In making a determination under paragraph (1), the Secretary of State may take into account any information on medicinal products, whether or not the Secretary of State obtained the information under these Regulations.

(3) Paragraph (4) applies where a manufacturer or supplier contravenes regulation 18, 19, 20, 21, 22, 23, 24 or 25 or paragraph (1) of this regulation.

(4) Where this paragraph applies, the manufacturer or supplier is liable to pay to the Secretary of State a penalty, calculated on a daily basis in accordance with Schedule 5 read with paragraph (8) and (9), until the manufacturer or supplier complies with the relevant regulation (except to the extent that it is no longer possible to meet a deadline because the deadline has passed).

(5) Where a manufacturer or supplier is liable to pay a penalty, the Secretary of State may make a demand for payment from the manufacturer or supplier.

(6) A demand made under paragraph (5) must be made by way of issuing a written notice to that manufacturer or supplier and must state—

(a)the amount of the penalty calculated in accordance with paragraph (4) up to the date on which the demand is made;

(b)the date before which the penalty must be paid;

(c)the daily rate at which the penalty continues to accrue until the manufacturer or supplier complies with the relevant regulation (except to the extent that it is no longer possible to meet the deadline because the deadline has passed); and

(d)the manufacturer’s or supplier’s appeal rights.

(7) Where a manufacturer or supplier is liable to pay a penalty under regulation 6 and liable to pay a penalty under this regulation for failing to provide a sales report in respect of the same period in accordance with Schedule 1 or 3, as the case may be, the Secretary of State may make a demand for the payment of a penalty under regulation 7(3) or under paragraph (5) but not under both.

(8) If a manufacturer or supplier sends a notice of an appeal to the Tribunal in accordance with regulation 4 of the Health Service Medicines (Price Control Appeal) Regulations 2000(1), in respect of a demand made under paragraph (4), the period beginning on the date that the notice is received by the Tribunal to the date on which the appeal is finally determined or is withdrawn is discounted for the purposes of the calculation of the number of days in respect of which the manufacturer or supplier contravenes regulation 18, 19, 20, 21, 22, 23, 24 or 25 or paragraph (1) of this regulation, as the case may be.

(9) For the purposes of calculating the amount of penalty by reference to a number of days, the day on which the manufacturer or supplier starts to comply with the relevant regulation, does not count towards the calculation of that number of days.

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