Improved QRD template for human medicines

messages in brief | 13/09/2011

The QRD (Quality Review of Documents) working group of the European Medicines Agency (EMA) published the new version of the QRD template for central procedures at the end of July 2011. The template for MR/DC or referral procedures followed at the end of August 2011.


In the changes to the template, the main focus was on the package leaflet. The experience gained over the past five years in the course of the readability tests, which are mandatory for marketing authorization, was directly incorporated into the new version. Representatives from patient organizations, the pharmaceutical industry, academia and national authorities were involved in the creation of the updated version.


The new version of the QRD template for medicinal products for human use is available on the EMA website.


Implementation will take place for centralized procedures according to the EMA's "Implementation Plan"; for DC approval procedures, adaptation is possible until day 120. No adaptation is foreseen for ongoing MR procedures, variation procedures or renewal procedures.

For existing marketing authorizations, the adjustment should be made as part of the next text-relevant Type II Variation, Renewal or Line Extension within the next two years. For existing approvals without variations, deferral to three years is possible. No conversion is planned via Type IA or minor text-relevant IB Variations (e.g., package sizes). No additional user testing is required.


Further information:

Implementation Plan


Further inquiry note