EMA publishes Principles for QR Codes

Recommendation

5/6 October 2022

Design Controls for Drug - Device Combination Products - Live Online Training

The European Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) published a position paper in April 2014 on the use of QR codes on the outer packaging and the package leaflet of nationally authorised medicinal products. Read more in the news CMDh Position Paper on QR Codes published. QR stands here for "Quick Reponse".

Now, the European Medicines Agency (EMA) also released on 22 July 2015 details about the use of QR codes on the outer packaging and package leaflet of centrally authorised medicinal products.

Following information can - for example - be made available via QR codes:

• Package leaflet (completely or partially)
• Excerpts from the SmPC
• Training material (according to the risk management plan)
• Diverse texts for which acceptance from the EMA is available

The regulations now adopted by the EMA comply with those for nationally authorised medicinal products.

You can find EMA's tips on QR codes in the document Quick Response (QR) Codes in the Labelling and Package Leaflet of centrally authorised Medicinal Products.