October 2021: EMA Update

European Medicines Agency (EMA) updated the Guide on Access to Unpublished Documents on 21 October 2021. This is the fourth revision to the original guide published on 24 November 2014.

Guide on access to unpublished documents complements Policy 43, EMA’s policy on access to documents (related to medicinal products for human and veterinary use). This guide details the Agency’s process to deal with all written requests, especially requests made electronically, for access to any document originated, received, or held by the Agency (i.e. reactive disclosure).

Following are the updates made in the fourth revision to the Guide:

  1. The ‘Access to Documents Service’ (ATD Service) replaced ‘Document Access and Publication Services’ (DAP Services) throughout the document. DAP Services was a set up to operate the process for requests for access to documents held by EMA.
  2. Guidance related to the use of radio buttons ‘Please select your type of inquiry’  and ‘I want help identifying which unpublished document I need’ in the AskEMA web form. (Please refer to Questions 1 and 4 in the guide for more details).
  3. Guidance on what the EMA considers as ‘one document’. A (non-exhaustive) list of what the Agency considers as one document is provided. (Please refer to Question 18 in the guide for more details).

More information can be found here.