2. European Legislation – Directive 2001/83

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1. European Legislation – Directive 2001/83

1.5. Pre-marketing and scientific information


The European regulation makes clear that any advertising of a medicinal product is prohibited until it has been granted a marketing authorisation. Only approved medicinal products can be advertised in accordance to the terms of its marketing authorisation (no off-label use may be advertised). However, the exchange of medical and scientific information during the development of a medicine is not prohibited unless it constitutes promotion. Only technical and purely scientific information can be presented. Therefore, scientific information material, such as copies of reports on the outcome of clinical studies, or scientific presentations and publications, may be made available at scientific meetings or conferences by using the non-proprietary name of the active ingredient(s) (INN) as long as the anticipated new product name is not mentioned or otherwise identified.