What is SmPC?
SmPC, or Summary of Product Characteristics, is one of the most critical regulatory documents in the European pharmaceutical industry. It forms the core scientific communication for healthcare professionals and supports the safe and effective use of medicinal products.
📌 What Is an SmPC?
The SmPC is a legally approved document that outlines detailed scientific and safety information about a medicinal product. It is approved as part of the Marketing Authorisation (MA) and is designed for use by healthcare professionals.
🎯 Purpose of the SmPC
- Provides evidence-based data on safety, efficacy, and dosage
- Supports prescribing decisions
- Forms the basis of the Patient Information Leaflet (PIL) and labelling
- Used in pharmacovigilance, inspections, and advertising claims
🏛️ Regulatory Basis for SmPC
The SmPC is mandated under Directive 2001/83/EC, Article 11 and is guided by:
- EMA SmPC Guideline (Rev. 2)
- ICH guidelines
- QRD (Quality Review of Documents) templates
🧾 SmPC Format: Standard EU Structure
The SmPC is structured into 9 main sections and 4 administrative ones. Here’s an outline:
1. Name of the Medicinal Product
Includes brand name, strength, and pharmaceutical form.
2. Qualitative and Quantitative Composition
Lists active substances and excipients. Highlight excipients with known effects.
3. Pharmaceutical Form
Describes physical characteristics of the product (e.g., tablet, injection).
4. Clinical Particulars
- 4.1 Therapeutic Indications
- 4.2 Posology and Method of Administration
- 4.3 Contraindications
- 4.4 Special Warnings and Precautions
- 4.5 Interactions with Other Medicinal Products
- 4.6 Fertility, Pregnancy and Lactation
- 4.7 Effects on Ability to Drive and Use Machines
- 4.8 Undesirable Effects
- 4.9 Overdose
5. Pharmacological Properties
- 5.1 Pharmacodynamic Properties
- 5.2 Pharmacokinetic Properties
- 5.3 Preclinical Safety Data
6. Pharmaceutical Particulars
- 6.1 List of Excipients
- 6.2 Incompatibilities
- 6.3 Shelf Life
- 6.4 Storage Conditions
- 6.5 Container Type
- 6.6 Disposal Instructions
7–10. Administrative Information
- 7. MA Holder Details
- 8. MA Number(s)
- 9. Date of Authorisation / Renewal
- 10. Revision Date
📦 When Is the SmPC Updated?
Common update triggers include:
- New clinical data (efficacy/safety)
- Changes in manufacturing or formulation
- Post-marketing surveillance (RMP, PSUR)
- Type II or IB regulatory variations
🧠 SmPC vs PIL vs Label
| Document | Target Audience | Content Type |
|---|---|---|
| SmPC | Doctors, Pharmacists | Scientific and Technical |
| PIL | Patients | Simplified, Layperson Terms |
| Label | Patients & Pharmacists | Key Use & Storage Info |
📋 Best Practices in SmPC Authoring
- Use the latest QRD templates
- Use consistent terminology and concise language
- Ensure alignment with PIL and packaging label
- Update with safety signals or regulatory changes