Header graphic for print
Focus on Regulation

Access to documents held by EMA: access requests by non-EU applicants to cease

The EMA has announced that, from 15 June 2018. The Agency will cease to accept requests for access to documents by non-EU applicants. The EMA announced that the Agency’s decision was a result of the high volume of access requests and the related excessive administrative workload.

Article 2(1) of Regulation 1049/2001, governing access to documents, permits applicants from the EU to request access to documents held by the EU institutions and agencies, including the EMA. The EU institutions and agencies have, however, the discretion to extend these rights to applicants from third countries.

Relying on this discretion, the EMA extended the possibility to request access to document held by the Agency to non-EU applicants. A significant increase in access to document requests in recent years has meant that the EMA has been obliged to change its approach.

The EMA Annual Report 2017 described how the number of requests for access to documents received by the EMA had increased from 377 in 2014 to 844 in 2017.

Faced with this major increase in requests, the EMA has announced a change of its policy “in order to avoid EMA’s core business tasks and performance being jeopardised by the administrative workload” related to the access to documents procedures.

The change in policy by EMA may limit the right of applicants from the UK to request access to documents held by the Agency following Brexit.