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 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.


PDF iconPresentation - 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.

Wording of therapeutic indication - A guide for assessors of centralised applications

When is it relevant to include a bodyweight limit in the wording of a paediatric indication?

Scientific guidelines with SmPC recommendations

Scientific guidelines with summary-of-product-characteristics recommendations

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