Module 6

04/10/2024

Patient Information

The Organisation for Professionals in Regulatory Affairs

23

Package leaflet/Patient Information Leaflet

What is the Package Leaflet?

The leaflet in every pack of medicine that contains information on the medicine for end-users, such as patients and animal owners.

• Product information (PI) of a medicine includes the package leaflet for patients.

• Provided in each pack of the medicinal product or provided at time of receipt (e.g. COVID-19 vaccines) can also be found on the websites of EU regulators.

• Must be written in accordance with the SmPC.

• Both SmPC and PL must align to ensure that the information provided to healthcare professionals and patients is coherent and accurate. Discrepancies between the two can lead to confusion, misuse, or non-compliance with medication guidelines.

• Audience for the package leaflet is the patient/carer

• Written in layperson’s language, how the information is worded is important in making sure the key messages for safe use can be understood.

• Any updates/versioning of SmPC should be considered for package leaflet too

• Previously called patient information leaflet (PIL)

• Precise templates to be followed – QRD

The Organisation for Professionals in Regulatory Affairs

24

12