European Union Pharma Regulation and Directive and the Patient Information Leaflet

ACR Malta had a discussion with the European Consumer Organisation (BEUC) and the Kunsill Nazzjonali ta L-Anzjani (KNA) to discuss the current discussions at EU level where there may be the introduction of a QR code to replace the paper information leaflets that accompany packaged medicines.     At the moment there are ongoing discussions at EU level on Pharma Regulation and Directive. We wished to check out the Maltese Authorities’ position.  

Following communication with the Minister of Health and Active Aging, Dr Jo E Abela, he clarified that, “My direction of a few months ago is that leaflets in the English language shall be supplied along with the QR code you mention. This is precisely because I’m worried about the digital divide still inherent to ageing.”

We the ACR and the KNA shall continue to insist that eliminating the information leaflet completely will impact negatively on a section of the population not digitally savvy.

The situation has now reached the Trialogue stage whereby the institutions will now discuss the adoption and implementation.