Documentation for the PIM Data Exchange Standard (DES)
*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.