Advertising of medicinal products for human use

1) OBJECTIVE

To lay down common rules relating to the advertising of pharmaceuticals.

2) COMMUNITY MEASURES

Council Directive 92/28/EEC of 31 March 1992 regarding advertising of medicinal products for human use.

This Directive was repealed by the Community code relating to medicinal products for human use.

3) CONTENTS

Generally speaking, all advertising relating to a medicinal product:

• is forbidden if the medicinal product has not been granted a marketing authorization;
• must be compatible with the information listed in the summary of the product's characterisitics;
• must encourage the rational administration of the medicinal product;
• must not be misleading, within the meaning of Council Directive 84/450/EEC (Official Journal L 250, 19.09.1984).

The following are prohibited:

• advertising to the general public of medicinal products which are only available on medical prescription;
• mentioning, when advertising to the general public, therapeutic indications where self-medication is not suitable;
• the distribution of free samples to the general public, as well as offers of gifts and bonuses.

Where authorized, advertising to the general public:

• must be set out in such a fashion that it is clear that the message is an advertisement, and that the product is clearly identified as a medicinal product;
• must include all the necessary information for correct administration of the medicinal product;
• must include an express invitation to read the instruction leaflet carefully;
• must not include elements incompatible with the rational administration of the medicinal product.

Any advertising to professionals and any documentation transmitted to them as part of the promotion of a medicinal product must include:

• essential information compatible with the summary of the product's characteristics;
• the classification of the medicinal product for supply purposes.

During each visit, medical sales representatives must provide the persons visited with the summaries of product characteristics in respect of each medicinal product which they present.

Inducements to prescribe or supply medicinal products (such as gifts, pecuniary advantages or benefits in kind, including invitations to travel or to congresses, with the exception of objects of an insignificant intrinsic value) are prohibited.

The supply of free samples to persons qualified to prescribe or supply medicinal products is subject to strict controls.

Pharmaceutical companies are required to establish within the company a scientific service in charge of information relating to medicinal products.

Provisions relating to the monitoring of pharmaceutical advertising are similar to those provided for in Directive 84/450/EEC on misleading advertising.