Medicines Act 1968

96 Advertisements and representations directed to practitioners. U.K.

(1) On and after the relevant date, no advertisement relating to medicinal products of a particular description, other than a data sheet, shall be sent or delivered to a practitioner—

(a) by a commercially interested party, or

(b) by any person at the request or with the consent of a commercially interested party,

unless the conditions specified in subsection (3) of this section are fulfilled.

(2) On and after the relevant date, no representation likely to promote the use of medicinal products of a particular description referred to in the representation shall be made to a practitioner by a person carrying on a relevant business, or by a person acting on behalf of a person carrying on such a business, unless the conditions specified in subsection (3) of this section are fulfilled.

(3) Those conditions are—

(a) that a data sheet relating to medicinal products of the description in question is sent or delivered to the practitioner with the advertisement, or is delivered to him at the time when the representation is made, or that such a data sheet has been sent or delivered to him not more than fifteen months before the date on which the advertisement is sent or delivered or the representation is made, and

(b) that the advertisement or representation is not inconsistent with the particulars contained in the data sheet.

(4) For the purposes of this section the relevant date—

(a) in relation to medicinal products of any description to which neither subsection (2) nor subsection (3) of section 16 of this Act is applicable, is the first appointed day, and

(b) in relation to medicinal products of any description to which either of those subsections is applicable, is the date of expiry of the period of six months from the date (or, if more than one, the latest date) on which, by virtue of one or more orders under section 17 of this Act, those subsections cease (or, if only one of them is applicable, that subsection ceases) to have effect in relation to them.

(5) Subject to section 121 of this Act, any person who contravenes subsection (1) or subsection (2) of this section shall be guilty of an offence, and, if he contravenes that subsection by not complying with the condition specified in paragraph (b) of subsection (3) of this section, shall be liable—

(a) on summary conviction, to a fine not exceeding £400, or

(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both,

and, in any other case, shall be liable on summary conviction to a fine not exceeding [F1 level 3 on the standard scale].

(6) In this and the next following section “data sheet” means a document relating to medicinal products of a particular description, which is prepared by or on behalf of the holder of a product licence which is applicable to medicinal products of that description and which—

(a) complies with such requirements as to dimensions and form, as to the particulars to be contained in it, and as to the manner (whether in respect of type, size, colour or disposition of lettering or otherwise) in which any such particulars are to be so contained, as may be prescribed for the purposes of this subsection, and

(b) does not contain any information relating to medicinal products of that description except the particulars so prescribed.

[F2 (7) Nothing in this section applies in relation to a relevant medicinal product, as defined by paragraph (1) of regulation 2 of the Medicines (Advertising) Regulations 1994, in respect of which there is required to exist a summary of product characteristics as defined by that paragraph.]

Textual Amendments

F1 Words substituted by virtue of (E.W.) Criminal Justice Act 1982 (c.48, SIF 39:1), ss. 38, 46 and (S.) Criminal Procedure (Scotland) Act 1975 (c. 21, SIF 39:1), ss. 289F, 289G and (N.I.) S.I. 1984/703 (N.I. 3), arts. 5, 6

F2 S. 96(7) inserted (29.9.1995) by S.I. 1995/2321, reg.2

Modifications etc. (not altering text)

C1 S. 96 extended (14.2.1994) by S.I. 1994/105, reg. 19, Sch. 4

S. 96 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)