Definition

The EU official document describing a medicinal product's properties and approved conditions of use, serving as the basis for healthcare professional information.

Example

The SmPC Section 4.8 lists 'Very common (≥1/10): headache; Common (≥1/100): nausea' providing expectedness reference and frequency information for adverse reactions.

Regulatory source

EU Directive 2001/83/EC

Common mistakes

Using the US PI for EU expectedness assessment or vice versa. Regional documents must be used for their respective regions.

Inspector question

Do you maintain current SmPCs for all your EU-marketed products? How do you track updates?

Related terms