ABSTRACT
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission,
In co-operation with the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas Directive 84/450/EEC4 harmonised the laws, regulations and administrative provisions of the Member States concerning misleading advertising; whereas this Directive is without prejudice to the application of measures adopted pursuant to that Directive;
Whereas all Member States have adopted further specific measures concerning the advertising of medicinal products; whereas there are disparities between theses measures; whereas these disparities are likely to have an impact on the establishment and functioning of the internal market, since advertising disseminated in one Member State is likely to have effects in other Member States;
Whereas Council Directive 89/552/EEC of 3 October 1989 on the co-ordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities prohibits the television advertising of medicinal products which are available only on medical prescription the Member State within whose jurisdiction the television broadcaster is located; whereas this principle should be made of general application by extending it to other media;
Whereas advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered; whereas advertising of medicinal products to the general public, where it is permitted, ought therefore to satisfy certain essential criteria which ought to be defined;
Whereas, furthermore, distribution of samples free of charge to the general public for promotional ends must be prohibited;
Whereas the advertising of medicinal products to persons qualified to prescribe or supply them contributes to the information available to such persons; whereas, nevertheless, this advertising should be subject to strict conditions and effective monitoring, referring in particular to the work carried out within the framework of the Council of Europe;
Whereas medical sales representatives have an important role in the promotion of medicinal products; whereas, therefore, certain obligations should be imposed upon them, in particular the obligation to supply the person visited with a summary of product characteristics;
Whereas persons qualified to prescribe medicinal products must be able to carry out these functions objectively without being influenced by direct or indirect financial inducements;
Whereas it should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them;
Whereas persons qualified to prescribe or supply medicinal products must have access to a neutral, objective source of information about products available on the market; whereas it is nevertheless for the Member States to take all measures necessary to this end, in the light of their own particular situation;
Whereas advertising of medicinal products should be subject to effective, adequate monitoring; whereas reference in this regard should be made to the monitoring mechanisms set up by Directive 84/450/EEC;
Whereas each undertaking which manufactures or imports medicinal products should set up a mechanism to ensure that all information supplied about a medicinal product conforms with the approved conditions of use,
HAS ADOPTED THIS DIRECTIVE:
Chapter I
Scope, definitions and general principles
Article 1
1 This Directive concerns the advertising in the Community of medicinal products for human use covered by Chapters II to V of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products.
