EUDRAC attended the recent EMA/DIA meeting where the philosophy and key points of the change to the RMP template were explained and discussed.
The use of RMP Rev.2 for all RMP submissions becomes mandatory for all RMP submissions as of 31 March 2018. Therefore marketing authorisation holders who require an update to their RMPs, e.g. via variation, will be required to update the RMP to Rev.2. Transitioning an RMP to Rev.2 is not a trivial process. Although many of the sections in the RMP Rev.1 mirror those in RMP Rev.2, there are several sections which require additional information and re-writing.
The updates to RMP Rev. 2 are substantial and many of the changes have been received positively by the industry. One of which is the reduction / removal of duplicated information; this has removed much of the administrative burden of maintaining an RMP. Other major updates include:
Please see a link to an overview training presentation of the main changes to RMP Rev. 2.
EUDRAC has transitioned several RMPs to the new RMP Rev.2 template and will continue to write and review RMPs into their new (and improved) format. For more information or support in writing or reviewing RMPs please contact us here.