Article 59 of Directive 2001/83/EC requires the leaflet to be drawn up in accordance with the SmPC and to reflect consultations with target patient groups, so that it is legible, clear and easy to use. It has to be in the official language or languages of the Member State where the medicine is sold, and it can't contain any element of a promotional nature. For centrally authorized medicines, the structure and standard wording follow the QRD template. In the US, patient information reaches users through other documents, such as Medication Guides and patient labeling.
The EU's pharmaceutical reform would let each Member State decide whether leaflets can be provided electronically, with a printed copy available on request, once it is adopted (see ePI).
Why it matters for labeling
The leaflet and the carton both derive from the approved product information, so they have to agree with the SmPC and with each other, in every language. Each strength and presentation can need its own leaflet, or a combined one where that has been agreed. After a variation, the leaflet and its date of revision have to be updated, and the old version withdrawn.
Common mistakes
- Leaflet text that doesn't match the latest approved SmPC
- Language versions updated at different times
- A leaflet for one strength or presentation packed with another
- The wrong date of revision after a variation
- Printed and electronic versions that differ