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4.—(1) Subject to the following provisions of these regulations, no advertisement shall be issued relating to any medicinal product which is for use by being administered to human beings, not being a medicinal product of a description or falling within a class specified in regulation 3 of these regulations, which is likely to lead to the use of such a medicinal product—
(a)for the purpose of the treatment of human beings for, or the prevention in human beings of—
(i)any disease of a description specified in column 1 of Part I of Schedule 2 to these regulations, except a purpose specified in column 2 of that Part of that Schedule, subject to the restrictions (if any) specified in column 3 of that Part of that Schedule, or
(ii)any disease of any system or part of the body specified in column 1 of Part II of that Schedule, except a purpose specified in column 2 of that Part of that Schedule, subject to the restrictions (if any) specified in column 3 of that Part of that Schedule, or
(iii)any adverse condition specified in column 2 of Part III of that Schedule opposite a system or part of the body specified in column 1 of that part of that Schedule, except a purpose specified in column 3 of that Part of that Schedule;
(b)for the purpose of the treatment of human beings for any physical injury specified in column 1 of Part IV of that Schedule except where the medicinal product is in a form and used for a purpose specified in column 2 of that Part of that Schedule;
(c)for any purpose specified in Part V of that Schedule.
(2) The restrictions imposed by paragraph (1) of this regulation shall not apply in relation to the issue of an advertisement in a newspaper or journal or to the transmission of any advertisement by the Independent Broadcasting Authority under the Independent Broadcasting Act 1973 where the holder of a product licence has, as soon as is reasonably possible, complied with or taken all necessary steps to ensure compliance with any direction in writing given by the licensing authority to the effect that an advertisement relating to medicinal products of the particular description to which such product licence relates ought not to be issued for any of the purposes to which paragraph (1) relates.
(3) For the purposes of this regulation the following shall be included among the acts taken to constitute the issue of an advertisement, that is to say—
(a)the sale or supply, or offer or exposure for sale or supply, of a medicinal product in a labelled container or package;
(b)the supply, with a medicinal product of any description, of a leaflet relating solely to medicinal products of that description.
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