PIM

Product Information Management

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Web	pim.emea.europa.eu

Introduction

PIM (Product Information Management) is a system introduced by the EMEA in the first instance in December 2005. It has been conceived as a means of:

increasing the efficiency of the management and exchange of product information (Summary of Product Characteristics, package leaflet and labelling) by all parties involved in the evaluation process through the structuring of the information and its exchange by electronic means; and
improving the quality and consistency of the published product information..

PIM may be used either within, or outside, the eCTD.

As the same document and data structures apply to product information in all languages for the Centralised Procedure, PIM is to be introduced for this procedure initially. The first live submission was therefore a New Marketing Authorisation application for the Centralised Procedure received in June 2006.

Once PIM is established for the Centralised Procedure it is anticipated that use of the system will be expanded to include the Decentralised, Mutual Recognition and National Procedures. In this context the specification phase for PIM in Mutual Recognition and Decentralised procedures (MRP/DCP) started in May 2007.

Key dates

	Date	Milestone
	December 2008	DES v2.7 for public consultation
	December 2008	LAT v4.1 production release
	December 2008	PRS v4.0.4 production release
	December 2008	Interim applicant guidance available
	December 2008	Pilot exit criteria published
	December 2008	PIM vendor engagement sessions
	July 2008	LAT v4.0 production release
	July 2008	PRS v5.0.1 production release
	June 2008	PRS v5.0 production release
	January 2008	LAT 3.4 production release
	January 2008	DES v2.6 production release
	December 2007	PRS v4.6 production release
	December 2007	DES v2.6 for public consultation
	December 2007	DES v2.5.1 production release
	December 2007	Finalisation of the specification phase for PIM in MRP/DCP
	December 2007	LAT v3.3 production release
	November 2007	PRS v4.5 production release
	October 2007	DES v2.5 production release
	August 2007	LAT v3.2 production release
	July 2007	LAT v3.1.2 production release
	July 2007	LAT v3.1.1 production release
	June 2007	DES v2.4 production release
	June 2007	LAT v3.1 production release
	May 2007	DES v2.2.3 and v2.3.2 production release
	May 2007	LAT v3.0.1 production release
	April 2007	DES v2.4 consultation release
	March 2007	LAT v3.0 production release