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The aim of this article is to consider the nature of mandatory genres (legally regulated genres) emanating from European Union directives and point to the challenges that such genres pose due to their legal origin and complex text production and text reception processes. Taking its point of departure in one of the most recent mandatory genres within an EU medicinal assessment and approval context (the European Public Assessment Report [EPAR] summary) the article presents the results of an empirical study of 15 EU-approved, Danish EPAR summaries, testing whether the respondents believe the EPAR summaries live up to their declared purpose. The article concludes that the majority of the respondents do not think the EPAR summary fulfills its communicative purposes of providing information about The Committee for Medicinal Products for Human Use's review and recommendation of the product and providing information that is understandable and useful to laypersons, respectively. The article points to some of the reasons why, in spite of careful preparation, and extensive guidelines prior to its ‘launch’ into the discourse community, the EPAR summary apparently fails to fulfill its communicative purposes.

Mandatory genres: The case of European Public Assessment Report (EPAR) summaries