Information
7.—(1) The following regulation shall be substituted for regulation 3 of the Health Service Medicines (Information Relating to Sales of Branded Medicines etc.) Regulations 2007(1).
“Information
3.—(1) Except as provided in paragraph (2), this regulation applies to any manufacturer or supplier of branded health service medicines who—
(a)holds either a wholesale dealer’s licence within the meaning of subsections (3) and (3A) of section 8 (provisions as to manufacture and wholesale dealing) of the Medicines Act 1968(2) or a marketing authorisation in respect of those branded health services medicines; and
(b)during the 12 months ending on 31st December of the preceding year, supplied branded medicines for heath service use to the value of £25 million or more.
(2) Except as provided in paragraph (4), the obligation to provide information under this regulation shall not apply to a manufacturer or supplier of branded health service medicines to whom a voluntary scheme applies (“scheme member”) who has agreed as part of its obligations under the scheme to provide within the time limits set out in paragraph (6) such information relating to the supply income in respect of each branded health service medicine as is required by the scheme.
(3) For any period during which there is no voluntary scheme, paragraphs (5) and (6) shall apply to a manufacturer or supplier who falls within paragraph (1).
(4) This regulation shall continue to apply to a scheme member who has received a demand for a penalty under regulation 4 until that penalty has been fully paid.
(5) A manufacturer or supplier of branded health service medicines 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 the following information in accordance with paragraph (6) in respect of each branded health service medicine which it supplies for the purposes of the health service—
(a)the supply income in respect of each pack size and strength of a branded product supplied by it to wholesalers, including the total number of products supplied;
(b)the supply 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 supplied;
(c)the supply income in respect of each pack size and strength of a branded product supplied by it to—
(i)dispensing doctors or, where a dispensing doctor is part of a partnership or is employed by a person or body to provide primary medical services to a partnership, that partnership, person or body;
(ii)GMS contractors; or
(iii)PMS contractors;
including the total number of products supplied;
(d)the supply 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 supplied; 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 required by paragraph (5) shall be supplied in accordance with the following table so that in respect of each month specified in the left hand column information will be supplied no later than the corresponding date in the right hand column.
| Month in which supply was made | Information to be received by the Secretary of State not later than |
|---|---|
| September 2008 | 31 October 2008 |
| October 2008 | 30 November 2008 |
| November 2008 | 31 December 2008 |
| December 2008 | 31 January 2009 |
| January 2009 | 28 February 2009 |
| February 2009 | 31 March 2009 |
| March 2009 | 30 April 2009 |
| April 2009 | 31 May 2009 |
| May 2009 | 30 June 2009 |
| June 2009 | 31 July 2009” |