The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC.
It is intended to enable companies to make sure that the information in SmPCs is of high quality when they submit them to the Agency as part of applications for new marketing authorisations or updates to existing marketing authorisations. It also aims to raise awareness of the information provided in SmPCs among healthcare professionals.
SmPCs
SmPCs are a key part of the marketing authorisation of all medicines authorised in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively. They are kept updated throughout the lifecycle of a medicine as new efficacy or safety data emerge.
SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients.
Presentation - Summary of product characteristics: What is it and what does it contain?
Training presentations
Presentation - SmPC training presentations user guide
Presentation - Introduction to the summary-of-product-characteristics guideline
Presentation - Section 1: Name of medicinal product
Presentation - Section 2: Qualitative and quantitative composition
Presentation - Section 3: Pharmaceutical form
Presentation - Section 4.1: Therapeutic indications
Presentation - Section 4.2: Posology and method of administration
Presentation - Section 4.3: Contra-indications
Presentation - Section 4.4: Special warnings and precautions for use
Presentation - Section 4.5: Interaction with other medicinal products and other forms of interaction
Presentation - Section 4.6: Fertility, pregnancy and lactation
Presentation - Section 4.7: Effects on the ability to drive and use machines
Presentation - Section 4.8: Undesirable effects
Presentation - Section 4.9: Overdose
Presentation - Section 5.1: Pharmacodynamic properties
Presentation - Section 5.2: Pharmacokinetic properties
Presentation - Section 5.3: Preclinical safety data
Presentation - Section 6: Pharmaceutical particulars
Presentation - Sections 7 to 10 related to the marketing authorisation; Sections 11 and 12 related to radiopharmaceuticals
Presentation - The summary-of-product-characteristics guideline and paediatric aspects
Presentation - The summary of product characteristics and older people
Presentation - Pharmacogenomics information in the summary of product characteristics
Presentation - Generic, hybrid and biosimilar products
Presentation - The summary of product characteristics of fixed combination medicinal products
Guidance for assessors (new)
The committee for human medicines (CHMP) has adopted guidance for assessors to follow a consistent approach in the process of defining therapeutic indications during the assessment of centralised applications for new active substances or new indications.
Scientific guidelines with SmPC recommendations
Scientific guidelines with summary-of-product-characteristics recommendations
- Guideline on SmPC
- SmPC Advisory Group
- Guideline: Excipients in the label and package leaflet of medicinal products for human use
- Annex II: Advanced-therapy regulation
- European Union legislation: Eudralex
- Quality Review of Documents: Product-information templates
- European public assessment reports
- Human medicines highlights
- Coordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) – product information
- Herbal medicines for human use