A draft version of ISO 11615 Medicinal Product and ISO 11616 Pharmaceutical Product has been published which features an updated Full Data Model figure.

The Figure shows numerous changes, most notably in the Medicinal Product and Marketing Authorisation classes. It features the addition of new data elements, a lot of changes in cardinality and reclassification of data elements. Iperion can help in the preparations for the changes featured in this draft update and assess the impact on Business. In the upcoming ISO/TC 215 meeting in Lillehammer there will be a vote on the finalisation of changes before publication.