What is PIM?
PIM stands for “product information management”, a new XML format for pharmaceutical product information (SPCs, labels, patient information leaflets etc) in Europe that is expected to replace Microsoft Word product information eventually. PIM is still in the testing stage for the EU Centralised Procedure at present. The Data Exchange Standard (the structure of the XML) is still evolving, and the EMEA reviewing system is still under active development. Like eCTD, PIM submissions are made as “sequences” – only changed information is submitted in each sequence, However, unlike eCTD, PIM is “bi-directional” – after the initial submission, agencies will respond with comments and queries in the PIM XML format.The rationale for PIM is best illustrated by giving an example. Product X has two forms (tablet and injection), and three strengths of each i.e. a total of 6 strengths. There is a separate patient information leaflet for each strength, each of which is avalable in 23 European national l
