In April 2014, the European Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) published a position paper on the use of QR codes on the outer packaging and the package leaflet of medicinal products.
Basically, there is the possibility to use symbols and pictograms as part of the identification to highlight and clarify significant facts.
In the future, the use of QR codes will be possible and will apply to both prescription and over-the-counter medicinal products.
According to the position paper of the CMDh, the QR codes can deliver product information as well as additional risk minimisation indications. Thanks to the QR code, the patient always has access to the latest update of the package leaflet. Yet, a corresponding note should appear to avoid eventual irritation among the patients because of discrepancies between the different versions of the package leaflet.
The position paper only refers to QR codes to access websites containing information about the medicinal products. It clearly distinguishes from other barcodes like those used as measures against counterfeits.
The paper also includes indications about the position of the QR code.
The use of a QR code must be declared in the marketing authorisation application; for authorised products, a notification must be sent to the regulatory authorities.
For further information please see the complete CMDh position paper entitled "Position Paper on the Use of QR Codes to provide Information about the Medicinal Product."