The package leaflet is derived from the Summary of Product Characteristics (SmPC). This package leaflet is intended for the patient or the consumer, so medical terms are translated in a patient-friendly manner in this document. The package leaflet is evaluated and approved by the MEB.
A new version of the QRD template, in which the package leaflet was amended, was published at the initiative of the MEB on 4 January 2010. The revision of the QRD template was brought about because of research done at Utrecht University, which formed part of a larger study dealing with the creation of more patient-friendly and clearer package leaflets.
The new template for the package leaflet will first be used for new applications and for full revisions (for renewals, for example). Marketing authorisation holders will only be asked to amend the texts for full revisions.
The following documents are of importance when drafting of a good package leaflet:
- Package leaflet of pharmaceutical products (MEB 5) provides an explanation of the conditions of the Medicines Act in terms of the package leaflet.
- To help improve the readability of the package leaflet, the MEB has drawn up a patient-friendly term list with patient-friendly translations of medical terms used in package leaflets.
- The Schrijfadviezen voor de geneesmiddelenbijsluiter is a supplement to the Europese Guideline on the Readability of the Labelling and Package Leaflet for Medicinal Products for Human Use.
- When applying for marketing authorisation or in the case of a variation to the package leaflet, the Declaration concerning the technical aspects of readability must be submitted.