The Health Service Medicines (Information Relating to Sales of Branded Medicines etc.) Regulations 2007

Information

3.—(1) Except as provided in paragraph (2), this regulation applies to any manufacturer or supplier of branded health service medicines to whom the PPRS applies (“scheme member”) who—

(a) holds either a wholesale dealer’s licence within the meaning of subsection (3) and (3A) of section 8 (provisions as to manufacture and wholesale dealing) of the Medicines Act 1968 or a marketing authorisation in respect of those branded health services medicines; and

(b) during the 12 months ending on 31st December of the year preceding that in which any quarter falls, supplied branded medicines for health service use to the value of £25 million or more.

(2) Except as provided in paragraphs (3) and (4), the obligation to provide information under this regulation shall not apply to a scheme member who has agreed as part of its obligations under the PPRS to provide within the time limits set out in paragraph (6) such information relating to the sales income in respect of each branded health service medicine as is agreed between the Secretary of State and the industry body.

(3) If the Secretary of State and the industry body fail to reach an agreement as referred to in paragraph (2), paragraphs (4) to (6) shall apply to a scheme member who falls within paragraph (1).

(4) This regulation shall continue to apply to a relevant scheme member who has received a demand for a penalty under regulation 4 until that penalty has been fully paid.

(5) A relevant scheme member shall, to the extent that the information is available to it (or would be available if it took reasonable steps to make it available), provide to the Secretary of State in respect of each branded health service medicine the following information in accordance with paragraph (6) in respect of each quarter (being a quarter falling in whole or in part after the coming into force of these Regulations) in which it has supplied branded health service medicines—

(a) the sales income in respect of each pack size and strength of a branded product sold by it to wholesalers, including the total number of products sold;

(b) the sales income in respect of each pack size and strength of a branded product supplied by it to retail pharmacists, including the total number of products sold;

(c) the sales income in respect of each pack size and strength of a branded product supplied by it to—

(i) dispensing doctors or where that doctor is part of a partnership or is employed by a person or body to provide primary medical services to that partnership, person or body;

(ii) GMS contractors; or

(iii) PMS contractors,

including the total number of products sold;

(d) the sales income in respect of each pack size and strength of a branded product supplied by it to health service hospitals, including the total number of products sold; and

(e) information about discounts given by it to wholesalers, retail pharmacists, dispensing doctors, GMS contractors, PMS contractors or health service hospitals which cannot be specifically attributed to a specific branded product or pack size or strength of a specific branded product.

(6) Information supplied pursuant to paragraph (5) in respect of a quarter shall be given no later than the time specified in the right hand column of the table below in relation to the quarter specified in the left hand column:

Quarter in which supply was made	Information to be received by the Secretary of State not later than
Ending on 31st March	30th April in the same year as the quarter falls
Ending on 30th June	31st July in the same year as the quarter falls
Ending on 30th September	31st October in the same year as the quarter falls
Ending on 31st December	31st January in the year next following the year in which the quarter falls