Definition

The leaflet supplied with a medicinal product for the patient, written in lay language and based on the SmPC. Must be approved as part of the marketing authorisation.

Example

The PIL explains how to take the medicine, possible side effects, and when to see a doctor, in language understandable to patients.

Regulatory source

Directive 2001/83/EC, Article 59

Common mistakes

Using a PIL that has not been approved or that deviates from the SmPC. Not updating PIL when SmPC is varied.

Inspector question

Show the process for keeping PIL in sync with SmPC after variations.

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