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?