08.09.2011 TitelNew pack inserts – EMA creates new templates
The European Medicines Agency (EMA) has presented its new templates for pack inserts. The new templates are designed to make patient information more comprehensible.
The advantages of the medicine and its correct application will be more strongly emphasised and the effects of the medicine on children explained in greater detail. The pack inserts will be more legible thanks to a larger font.
In the five years preceding the launch, the EMA consulted patients, pharmaceutical companies, consumer associations, academics and national regulators. The aim was to improve safety and efficacy in the use of medicines.
The new templates contain fewer standard formulations and give the manufacturer scope to emphasise the benefits of the medicine more strongly than previously. The texts should be as vivid as possible. The EMA provided the following examples:
“It has been demonstrated that taking this medicine can lead to reductions in blood sugar levels, especially in diabetes patients. This medicine can also help you to avoid complications.
This medicine can reduce your arthritis-linked pain.”
A special section is now intended to provide more detailed explanations of the specific risks involved when medicines are taken by children. Overall, the focus of the pack insert will be shifted from possible side effects to the symptoms to be treated.
“The new templates were presented in the context of the Quality Review of Documents human product-information template” on 22 July and can be accessed in all EU languages from the EMA website. They should be taken into account when a new preparation is licensed or the next time the pack insert is amended.
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