Definition

The legally approved document in the EU that describes a medicinal product for healthcare professionals: composition, therapeutic indications, dosing, contraindications, and safety information.

Example

The SmPC is the reference for prescribers; the PIL is the patient-friendly version derived from it.

Regulatory source

Directive 2001/83/EC, Article 11

Common mistakes

Promoting uses or dosing not in the SmPC. Updating the PIL without aligning to the approved SmPC.

Inspector question

How do you ensure promotional and medical information is consistent with the approved SmPC?

Related terms