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1.For the purposes of this Title, ‘advertising of medicinal products’ shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular:
the advertising of medicinal products to the general public,
advertising of medicinal products to persons qualified to prescribe or supply them,
visits by medical sales representatives to persons qualified to prescribe medicinal products,
the supply of samples,
the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,
sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,
sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.
2.The following are not covered by this Title:
the labelling and the accompanying package leaflets, which are subject to the provisions of Title V,
correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product,
factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims,
[F1information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products.]
Textual Amendments
1.Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorization has not been granted in accordance with Community law.
2.All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.
3.The advertising of a medicinal product:
shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties,
shall not be misleading.
1. Member States shall prohibit the advertising to the general public of medicinal products which:
(a) are available on medical prescription only, in accordance with Title VI;
(b) contain substances defined as psychotropic or narcotic by international convention, such as the United Nations Conventions of 1961 and 1971.
2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.
3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed.
4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
5. The prohibition referred to in paragraph 1 shall apply without prejudice to Article 14 of Directive 89/552/EEC.
6. Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes.]