Information3

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 196810 or a marketing authorisation in respect of those branded health services medicines; and

b

during the 12 months ending on 31^st 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