The Branded Health Service Medicines (Costs) Regulations 2018

• “virtual medicinal product pack” means an abstract representation of a relevant medicine as formulated in the medicines information standard which has any one or more of the characteristics of active ingredients, strength, excipients, pack size, method of administration or formulation in common with similar presentations which have been placed on the market for health service use by any manufacturer or supplier.

Direction to make a payment

Interest payable on late payment

Penalties

Demands and appeals

1A

Any payment required to be made under regulation 3(1AA) by a manufacturer or supplier to whom this Schedule applies must—

• (a) be paid annually at the same time as the relevant presentation report is due;

• (b) be paid by electronic transfer no later than the last day of the period within which the payment must be made; and

• (c) be calculated, where relevant, in accordance with the rules in paragraphs 3 to 9.

8

A manufacturer or supplier whose financial year does not end on 31st December must, in addition to the reports required to be provided in table 1, provide two or more audited sales reports or presentation reports to cover the period of 1st January to the last day of the relevant accounting reference period and from the first day of the subsequent accounting reference period to the end of 31st December of that calendar year so that, when taken together, the separate reports cover the entire calendar year.

9

A manufacturer or supplier must provide two or more separate sales reports, audited sales reports or presentation reports for the period the applicable report covers in which a change to the payment percentages under regulation 3 or 3A occurs so that information concerning supplies of presentations made before and after that change are contained in separate reports and, when taken together, those reports cover the entire calendar quarter, financial year and, where paragraph 8 applies, the calendar year, as applicable.