Summary of Product Characteristics (SmPC)
What is the SmPC?
The Summary of Product Characteristics (SmPC) is a legally required regulatory document in the European Union that provides healthcare professionals with authoritative information on the safe and effective use of a medicinal product.
It is a core component of the marketing authorisation for medicinal products in the EU and is governed by the European Medicines Agency (EMA) for centrally authorised products and by National Competent Authorities (NCAs) for nationally authorised products.The SmPC serves as the primary reference for prescribing decisions, product information systems, and downstream formats such as patient leaflets and electronic Product Information (ePI).
Why it Matters in Pharma Today
- Regulatory compliance — Required under EU law for all medicinal products, with defined format and content standards.
- Clinical guidance — Provides healthcare professionals with detailed product characteristics, indications, dosing, safety information, and contraindications.
- Foundation for other formats — Feeds directly into patient information leaflets (PILs), ePIs, and electronic health record systems.
- Consistency across markets — When linked to the Core Company Data Sheet (CCDS) in a structured content environment, ensures alignment with the global safety profile.
- Rapid update capability — Enables targeted updates to specific sections in response to new safety, efficacy, or manufacturing data.
Global Landscape
|
Region/Body |
Governing Entity |
Status |
| EU (Centrally Authorised Products) | EMA | SmPCs reviewed and approved centrally; published on EMA website. |
| EU (Nationally Authorised Products) | NCAs | SmPCs approved and published at national level. |
| Global Context | WHO, ICH | SmPC structure informs labeling harmonisation efforts internationally. |
How the SmPC Works in a Component-Based Authoring Model
- Author — Draft SmPC content from the CCDS and applicable EU regulatory guidance (QRD templates).
- Govern — Medical, regulatory, and legal review to ensure compliance with EMA/QRD formatting and content requirements.
- Approve — Submit for agency review and secure approval for initial marketing authorisation.
- Publish — Make SmPC publicly available via EMA or NCA websites and integrate into HCP-facing digital channels.
- Maintain — Update individual sections (e.g., contraindications, adverse events) as new data emerges, with updates validated against CCDS to ensure global alignment.
Structure of the SmPC (per EU QRD template)
- Name of the medicinal product
- Qualitative and quantitative composition
- Pharmaceutical form
- Clinical particulars (therapeutic indications, posology, contraindications, etc.)
- Pharmacological properties
- Pharmaceutical particulars
- Marketing authorisation holder
- Marketing authorisation number(s)
- Date of first authorisation/renewal
- Date of revision of the text
Example: SmPC in Practice
- New adverse event signal → CCDS updated → SmPC Section 4.8 revised → EMA/NCA submission for variation → update cascades to ePI and PIL.
- New formulation approval → SmPC Sections 2 and 3 updated → changes automatically reflected in digital channels.
FAQs
No. The SmPC is a region-specific regulatory document approved by EU authorities; the CCDS is a company-owned master document from which the SmPC is derived.
Whenever significant new safety, efficacy, or manufacturing data becomes available, and at intervals defined by regulatory obligations.
While the SmPC format is EU-specific, its structure and content often influence labeling in other jurisdictions.
