Following are some FAQs related to the Product Information Management Initiative (PIM). For more information and additional FAQs, please visit the PIM website
What is the difference between SPL and PIM? SPL and PIM have different objectives. SPL is designed for the provision of current prescribing information; PIM is designed for the exchange of information to support the registration process. PIM has support for multiple languages; SPL does not. PIM DES currently supports a transactional model whereas this is a future enhancement for SPL.
How will PIM be rolled out? Initially, it will be introduced in the Centralized procedure. Once it is established, it is anticipated that use will be expanded to include the Decentralised, Mutual Recognition and National Procedures.
What is the current roll out schedule for PIM? PIM will be optional for initial submissions via Centralised Procedure as of 25 November 2005. PIM will be optional for variations via Centralised Procedure as of 31 March 2006.
What is the PIM DES? The DES is the PIM Data Exchange Standard, which is based on the QRD templates and detailed in the Exchange of Product Information Specification, v. 2.0. This standard supports the exchange of PI information in all applicable languages. The DES includes all product information documents including SmPC, Annex II, Labeling and the package leaflet. Changes in the DES will be governed by the rules of the EU Module 1 change control procedure document.
Can PIM be used in the eCTD? Yes. PIM can be used in eCTD as well as non-eCTD.
If PIM is used in an eCTD, where does it go in the file structure? The “pim.xml” file should be placed in the ”13-pi” directory in place of section “131-
spclabelpl” as part of EU Module 1.
What are the benefits of PIM to my organization?
Enhanced ability for authors to focus on content and not format
Transition away from tedious paper-based processes
Responding to regulatory authority comments is simplified
Updating product information documents is simplified
Significant time and resource savings can be expected
What is the LAT? The LAT (Light Authoring Tool) is a free tool developed by EMEA that provides capability to create PIM compliant product information. It has viewing, editing and life-cycle management capabilities.
When will the LAT be available? Current plans are to make the LAT available by late December 2005.
