The following was agreed:
· The European Commission and Heads of Medicines
Agency have agreed with the phased wise implementation of ISO IDMP.
·Implementation
will start in July 2016, with an update of current Controlled Vocabularies to
ISO IDMP CV´s, release of Regional ISO implementation guide, etc.
·EMA
will update the information on their website about the deadline and phased wise
approach.
·The first phase is Iteration 1, in which additional data for the product
has to be submitted. The exact data fields are still to be defined. For now
these are 33 additional fields for ISO IDMP compared to xEVMPD.
· Industry is requested to provide real life
examples of the issues for the implementation of ISO IDMP. We are working on
these examples, but if you have any issue that you would like to have
clarified, please contact us: [email protected]
