Package leaflet: patient information leaflet in the pack

Article 58 of Directive 2001/83/EC makes a package leaflet obligatory in the packaging of every medicinal product unless all the required information appears directly on the outer or immediate packaging. Article 59 sets the content and its order: identification of the product and its therapeutic indications, the information a patient needs before taking it, instructions for proper use, a description of undesirable effects and what to do if they occur, a reference to the expiry date and storage, the names of the holder and manufacturer, the date of the last revision and, for products authorised under a mutual recognition or decentralised procedure, the name used in each Member State. The leaflet must be drawn up in accordance with the SmPC, written in terms that are clear and understandable to the patient, and, under Article 59(3), reflect the results of consultation with target patient groups. Article 63 requires it in the official language or languages of the Member State where the product is marketed.

In practice the leaflet is Annex IIIB of the product information on the QRD template, which fixes its headings and many standard sentences. It is reviewed in every procedure that changes the SmPC, and the readability guideline expects a user test for a new leaflet and a bridging justification where an existing test can be reused. Article 63(3) allows the authority to exempt a product from carrying certain particulars, or from the national language, where it is not intended to be delivered directly to the patient or where severe availability problems exist, which is used for hospital-only and some orphan products.

What goes wrong: the leaflet is translated from the English version instead of being adapted to the approved national SmPC, so the two disagree; standard QRD statements are paraphrased; updates from PSUSA outcomes are made to the SmPC but not carried into the leaflet; the Member State names required by Article 59(1)(f) are missing or out of date after a name change in one country; and readability is treated as a one-off test rather than a property to keep when later changes add warnings. Pack size and font size also fight for space, and a leaflet that passes review on screen can fail at print.

Under the new pharma package (not yet in force), the leaflet must be provided on paper and electronically, and Member States may allow electronic-only leaflets for some products; see ePI changes.