Guide on access to unpublished documents

On 9 December 2019 the EMA updated the guide on access to unpublished documents.

This document complements Policy 43: European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use). Policy 43, which applies in the context of the Agency’s activities in the fields of medicinal products for human and veterinary use, has a two-fold approach. The present guide describes how the Agency deals with all written requests, especially requests made electronically, for access to any document originated, received or held by the Agency (i.e. reactive disclosure). The second one concerns proactive disclosure of EMA documents, either through the Agency’s website or other sources of publication.

This guide, developed by the ATD team within the Documents and Publication (DAP) Service, should be read in conjunction with the information already provided by the Agency on the dedicated webpage on Access to Documents.

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