EMA releases practical guidance on access-to-documents requests

By William Chin, PhD, Scientific Coordinator, EUCRAF

Do you know that according to EMA's 2010 access-to-documents policy, citizens can have access to all documents held by EMA. The Agency has reviewed its process for handling access-to-documents requests to provide a tailored service for requesters. An EMA coordinator will be assigned to each request to liaise with the requester in order to better understand their needs. The guide contains a set of 12 questions which give you an overview of the request procedure:

Q1. How can I request a document? 

Q2. Who can request a document?

Q3. What type of documents can I request? 

Q4. What if I am not sure which document I want? 

Q5. In what language may I submit a request for a document? 

Q6. How will my request be processed? 

Q7. If access is granted how will I receive my document?

Q8. What can I do if I am refused access to documents? 

Q9. When is it most likely that the Agency will refuse access? 

Q10. Will the Agency grant access to documents produced by others? 

Q11. Can I copy, publish or sell the documents that are obtained from the Agency? 

Q12. What if I do not receive the document I have requested on time? 

To see the answers to the questions above, the full document is available on the following link at EMA website: EMA guide on access to its unpublished documents

Source: EMA News & Event, 24 Nov 2014