Revision 1 of EMA GVP Module V on risk management system was published on 25 April 2014, mainly to amend the requirements of part VI of the RMP as EMApublished already in the updated RMP templates, to introduce amendments in line with the new requirements for variation applications and to align the definitions of Missing information and Safety concern and their explanatory notes with legal requirements, as well as to amend the definition for Risk minimisation activity.