At the end of June 2019 EMA published new QRD template (v10.1) for centrally authorized products.
Marketing Authorization Holders are strongly encouraged to update the product information in the next regulatory procedure which affects the summary of product characteristics (SmPC), labelling or package leaflet.
The product information of new MA applications submitted to EMA should follow the new template at latest by Day 181 of the procedure.
For more information and new QRD templates in all European languages visit https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-templates
If you need support from Asphalion, we can help you with the change or revision of the QRD version in your texts. Please contact us [email protected]