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G-RegsTM

Pharmaceutical Marcoms Rules in Europe

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Pharma

As might be expected, the Pharmaceuticals category is arguably the most heavily regulated in Europe. Uniquely, regulation is either statutory or provided by the Pharmaceutical industry itself. The self-regulatory advertising organisations (e.g. CAP and BCAP in the UK, the ARPP in France, IAP in Italy) largely take a back seat, though in some cases they administer the regulations in terms of consumer and competitor complaint. We have assembled the rules so as to separate Prescription-only medicines, which may not be advertised to the public, and OTCs which, with heavy surrounding stipulations, can be advertised in mass media. While there is no central EU (as with, for example, cosmetics) marcoms mandate, all medicinal products must have a Marketing Authorisation in order to advertise per the SPC (Summary of Product Characteristics), a process that is managed by the European Medicines Agency based in London

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