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EU medicine reports get clinical

25 February 2015

At the beginning of 2015 the European Medicine Agency (EMA) decided that for the future they will publish each clinical report that underpins their decision making on certain medicines. These reports will be released as soon as a decision on an application to centralise marketing authorisations for a medicine has been taken.

Whilst the reports are available to the public they cannot be used for commercial purposes nor should they contain commercially confidential information.

The EMA will phase in their publications during 2015 and it is interesting to note that the EMA is considering in the future making available individual patient data as part of their reports. Naturally privacy professionals amongst others will have concerns about how data protection and data privacy of patients will be achieved.  

For further information please contact Robert Bond on 0207 427 6660 or robert.bond@crsblaw.com