2. European Legislation – Directive 2001/83

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1. European Legislation – Directive 2001/83

1.1. Definition with inclusions - exemptions


Article 86

1) defines advertising for Title VIII as:
‘any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products’; it includes in particular the following topics:

  • 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,
  • 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,
  • information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products.

[Information can be categorised as ‘promotional’ or ‘non-promotional’. From paragraph 2 of article 86 it can be inferred that those certain items are specifically exempt from the rules set by the directive, but only if they are non-promotional in nature. ‘Promotional information’ includes advertising and sales materials and/or activities related to specific products. ‘Non-promotional’ information in the directive covers legally mandated information (in the directive PL and labelling; but also consider what is mentioned in lesson 1 in this course, e.g., EPARs), and other items, which are, however, defined by restrictive wording such as ‘non-promotional nature’, ‘no product claims’ ‘no reference, even indirect, to medicinal products’ thus distinguishing them from ‘promotional’. Regulatory Authorities are observant of press releases and/or other material to ensure that they are not promotional. Regulators are also vigilant of any methods that may be used to promote medicinal products indirectly.Moreover, it is common practise for pharmaceutical companies within their framework of self-regulation to monitor the ‘scene’ and take action when violations . (see also 2.4 measures to monitor).]


Article 87

States that:

1)  a medicinal product without a marketing authorisation cannot be advertised; all parts of an advertisement must comply with the particulars listed in the summary of product characteristics (SmPC)

2)  advertising shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties and shall not be misleading