Implementation of the updates in line with the QRD template for medicinal products

Implementation of the updates in line with the QRD template for medicinal products

Information for marketing authorisation holders

The European Medicines Agency’s Working Group on Quality Review of Documents revised the Quality Review of Documents (QRD) template for the product information for medicinal products (Summary of product characteristics, Patient information leaflet and labelling text) in April 2013.

The information regarding national reporting system of suspected adverse reactions for healthcare professionals and patients was added. Applicants were encouraged to implement the updates in line with the QRD template for medicinal products with regulatory activity until April 2015 and for medicinal products without regulatory activity until April 2016. Further information please see The Heads of Medicines Agencies website Q&A section (answers to Q 2.11.a and 2.11.b).