ENLI drafts guidance on documentation

The Danish Ethical Committee for the Pharmaceutical Industry (ENLI) receives several inquiries from companies who seeks advice regarding use of documentation in their marketing, and therefore a new guide on this topic will be drafted.

The new guidance will supplement the Promotion Code and will clarify which documentation the companies may use in their marketing, including use of recommendations from the Danish Medicines Council and Real World Data etc. Focus will be on the distinction between factual information and marketing claims related to a company's own product.

The guidance is intended to be useful in practice and should be able to answer what a company should do in a given situation. The guide will therefore contain specific examples as well as a list of frequently asked questions and answers. ENLI encourages everyone to send any questions or examples that should be addressed in the guide to sekretariat@enli.dk.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2018 Issue (Thomson Reuters).