Keywords
Summary

Keywords

1. Approximation of laws – Medicinal products for human use – Directive 2001/83

(Directive 2001/83 of the Parliament and of the Council)

2. Approximation of laws – Medicinal products for human use – Directive 2001/83

(Directive 2001/83 of the Parliament and of the Council, Art. 90(c) and (j))

3. Approximation of laws – Medicinal products for human use – Directive 2001/83

(Directive 2001/83 of the Parliament and of the Council, Arts 87(3), 88(6) and 96(1))

Summary

1. Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, brought about complete harmonisation in the field of advertising of medicinal products and lists expressly the cases in which Member States are authorised to adopt provisions departing from the rules laid down by that directive. The directive must therefore be interpreted to the effect that a Member State may not provide, in its national legislation, for an absolute and unconditional prohibition, in the advertising of medicinal products to the general public, on the use of statements from third parties, whilst their use can be limited, under that same directive, only by reason of their specific content or the type of person making the statement.

(see para. 39, operative part 1)

2. Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, requires Member States to provide, in their national legislation, for a prohibition on the use, in the advertising of medicinal products to the general public, of statements from third parties where those refer, in improper, alarming or misleading terms, to claims of recovery within the meaning of Article 90(j) of Directive 2001/83, the term ‘claims of recovery’ having thus to be interpreted as not including references to the reinforcement of a person’s well‑being where the therapeutic efficacy of the medicinal product in terms of the elimination of a particular illness is not referred to. Article 90(c) of Directive 2001/83 also requires Member States to provide, in their national legislation, for a prohibition on the use, in the advertising of medicinal products to the general public, of statements from third parties where they give the impression that the use of the medicinal product contributes to the reinforcement of general well‑being.

(see para. 52, operative part 2(a))

3. Articles 87(3), 88(6) and 96(1) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, prohibit the advertising of a medicinal product by means of a prize draw announced on the internet, inasmuch as it encourages the irrational use of that medicinal product and leads to its direct distribution to the general public and to the presentation of free samples.

(see para. 59, operative part 2(b))