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Documentation for the PIM Data Exchange Standard (DES)

Version DES 2.5 DES 2.5.1 DES 2.6 DES 2.6.1 DES 2.7 DES 2.7.1 DES 2.8 Beta***
QRD Template* 7.2 7.2 7.2 7.2 7.3 7.3.1 7.3.1
Release Notes View View View View View View View
Specifications View View View View View View View
Specs with Tracked Changes         View   View
DTD and
Style-sheets
Download Download Download Download Download Download Download
Example 1 ** EX1.zip EX1.zip EX1.zip EX1.zip EX1.zip EX1.zip EX1.zip
Example 2 EX2.tgz EX2.tgz EX2.tgz EX2.tgz EX2.tgz EX2.tgz EX2.zip
Example 3 EX3.zip EX3.zip EX3.zip EX3.zip EX3.zip EX3.zip EX3.zip
Example 4 EX4.tgz EX4.tgz EX4.tgz EX4.tgz EX4.tgz EX4.tgz EX4.zip
Example 5 EX5.zip EX5.zip EX5.zip EX5.zip EX5.zip EX5.zip EX5. zip
Example 6 EX6.tgz EX6.tgz EX6.tgz EX6.tgz EX6.tgz EX6.tgz EX6.zip
Feature Coverage View View View View View View View
Unit Testing UT UT UT UT UT UT UT
Upgrade Procedure 2.4 -> 2.5 2.4 -> 2.5.1 2.5 -> 2.6 2.5 -> 2.6.1 2.6->2.7 2.6->2.7.1 2.7x->2.8
Erratum      
Erratum to the Specifications of DES 2.6.1.pdf
     
Work Plan         View   View
Beta Validation Rules
            View

*QRD Implementation Guidance: http://www.ema.europa.eu/htms/human/qrd/qrdtemplate.htm

** PIM Examples: Any resemblance between the example medicinal products used in this documentation (PIM EX1 - PIM EX6) and real products is not entirely coincidental. However, the examples of regulator comments, applicant responses, and activities at certain procedural steps do not relate to real evaluation procedures for these products.

*** DES 2.8 Beta: The Beta release is provided so that stakeholders can plan its implementation in systems. It cannot be used to exchange submissions. It contains most of the changes planned for v2.8, and the Work Plan contains details of outstanding changes. Note that headings.xml is distributed as part of the Beta release, though it will be separately versioned and distibuted by the time of the official release.

For the status of DES versions, see the DES Version Status page.

Browser plug-ins to display TIFF, SVG and MathML can be downloaded here.
An open source software that manages zip, tar and gzip formats can be downloaded here.

The Change Control Process document can be used in tandem with the EMA EU Change Request/Q&A Form to suggest enhancements to the PIM Data Exchange Standard.

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© 1995-2010 European Medicines Agency
Last update: 13-12-2010
Contact: pim@ema.europa.eu