PIM

PIM Introduction

 * PIM (Product Information Management) ** is a system introduced by the EMEA as a means of:

**[28-Mar-2011]** The [|PIM Project] was closed by the European Medicines Agency (EMA) effective March 28, 2011.
 * 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.

**[23-Dec-2009]** **Controlled Vocabulary [European Union]**

[|EUTCT]

**[Sept 2009]** **EMEA Implementation of PIM... Statement of Intent:** []

For more comprehensive information on PIM, please see []

PIM Business Problem
For the Centralized Procedure in the EU, separate documents are needed for each trade name, formulation, strength and presentation. These documents must also be translated into the official EU languages.

Key Differences between SPL and PIM
SPL || PIM ||
 * ** Purpose ** || To facilitate the timely distribution of authoritative, up-to-date information about regulated products in electronic form for direct use by health care professionals or programmatic use by e-prescribing decision support systems. || To facilitate the exchange of information between sponsors and regulators in aid of improving the quality of the human readable text. ||
 * ** Information Flow ** || One way, from sponsor to agency to NLM, though invalid or non-conformant instances may be rejected by the agency,

The SPL standard includes provision for comment exchange and tracking so it could in principle be used for information exchange between the sponsor and the agency during labeling negotiations. || Bi-directional. Initially supplied by sponsor but used for exchange of comments. ||
 * ** XML Standard ** || Based on the ANSI-HL7 SPL (Structured Product Labeling) Standard, a XML schema-based instance of W3C XML. || Based on what the EMEA calls the Data Exchange Standard (DES), which is based on their QRD templates and is a DTD based instance of W3C XML ||
 * ** Mandatory ** || Yes || No ||
 * ** Other differences ** || The SPL standard includes provision for coded knowledge representation of both product characteristics and clinical application. Coded clinical information is not permitted under the current implementation rules, and is to be provided by the FDA in separate instances to ‘index’ the product instances.

The SPL standard also includes provisions for carrying coded information about corporate entities in the instance header, and so can be (and soon will be) required for reporting labeler information and registering establishments. || Content of the text of labeling documents is more granular to facilitate re-use across documents, but PIM has no provision for coded knowledge representation pertaining to the product or its clinical application ||