Regulatory information - EMA releases practical guidance on access-to-documents requests

The European Medicines Agency (EMA) has released a practical guide detailing the process for requesting access to unpublished documents held by the Agency.

As foreseen by European Union law and detailed in the EMA's 2010 access-to-documents policy, citizens can have access to documents held by EMA.

As part of its reorganisation initiated in 2013, the Agency has reviewed its process for handling access-to-documents requests to provide a tailored service for requesters. Each request is now assigned to an EMA coordinator who liaises with the requester to understand their needs.

The guide details in particular:

• how a request is processed;
• how the documents are provided;
• in which cases access can be refused;
• how a requester can appeal EMA's decision to refuse access to documents.

Access-to-documents requests should be sent to the Agency using the online form.