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PIM (Product Information Management) Overview
The PIM initiative started in 1999 as a way to handle product information for registration of human medicines via the Centralised Procedure in Europe. European Medicines Agency (EMEA), national competent authorities and European Federation of Pharmaceutical Industries and Associations (EFPIA) jointly sponsor the PIM initiative.
The initial implementation date is November 25, 2005. Implementation is voluntary at this time. Currently, only sponsors utilizing the Centralised Procedure (EMEA) for human medicinal product registration in the EU can submit in the PIM format. Eventually, the program will be expanded to cover Mutual Recognition, Decentralised and National registration procedures.
PIM evolved as a way of managing the numerous product information documents associated with a single trade name. The large number of documents multiplied across 21 linguistic versions and multiple agencies made the management of such information extremely tedious and time consuming. The PIM model offers some relief in this area, enabling sponsors to submit only changed information, thus minimizing sponsor and agency resources required for submission and review.
To assist sponsors in the implementation process, the EMEA plans to provide a Light Authoring Tool (LAT), which can be used to create and manage PIM submissions. It is being designed for small and medium size organizations in support of EC 726/2004, a European directive that addresses small business assistance. The tool is expected to be available in late December 2005.
Currently, PIM is optional for all initial applications submitted via the Centralised Procedure. It will also be optional for variations submitted via the Centralised Procedure as of March 31, 2006.
PIM Website
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