hese questions and answers deal with questions related to how to submit a request for access to official European Medicines Agency documents. They are complementary to the Agency’s policy on access to documents.


Posted on the EMA website on 11 February 2013

What can I ask for under Regulation (EC) No 1049/2001?
How do I make a request?
Can I request access to marketing-authorisation dossiers under Regulation (EC) 1049/2001?
I know what to ask for. What do I do next?
How should I phrase the request?
What happens after I have made a request?
What happens if my request is not clear enough?
What is the procedure for examining applications for access to documents?
Does the system of exceptions always justify not granting access to the whole document?
What is redaction?