Regulatory information - EMA releases practical guidance on access-to-documents requests
NewsCorporate
The European Medicines Agency (EMA) has released a Guide on access to unpublished documents detailing the process for requesting access to unpublished documents held by the Agency.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.