How to prepare and review a summary of product characteristics
This page includes guidance for pharmaceutical companies and regulators on how to prepare and review summaries of product characteristics (SmPCs) for human medicines.
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.
Summary of product characteristics (SmPC) - What is it and what does it contain?
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Presentation - SmPC training presentations user guide (PDF/250.38 KB)
First published: 21/01/2013
Last updated: 21/01/2013 -
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Presentation - Introduction to the summary-of-product-characteristics guideline (PDF/307.35 KB)
First published: 21/01/2013
Last updated: 21/01/2013 -
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Presentation - Section 1: Name of medicinal product (PDF/137.54 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 2: Qualitative and quantitative composition (PDF/192.59 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 3: Pharmaceutical form (PDF/170.29 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 4.1: Therapeutic indications (PDF/177.93 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 4.2: Posology and method of administration (PDF/351.78 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 4.3: Contra-indications (PDF/174.94 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 4.4: Special warnings and precautions for use (PDF/273.37 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 4.5: Interaction with other medicinal products and other forms of interaction (PDF/185.51 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 4.6: Fertility, pregnancy and lactation (PDF/185.9 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 4.7: Effects on the ability to drive and use machines (PDF/138.37 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 4.8: Undesirable effects (PDF/390.28 KB)
First published: 21/01/2013
Last updated: 25/06/2020
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Presentation - Section 4.9: Overdose (PDF/155.24 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 5.1: Pharmacodynamic properties (PDF/261.96 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 5.2: Pharmacokinetic properties (PDF/237.37 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 5.3: Preclinical safety data (PDF/143.88 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Section 6: Pharmaceutical particulars (PDF/218.59 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Sections 7 to 10 related to the marketing authorisation; Sections 11 and 12 related to radiopharmaceuticals (PDF/190.43 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - The summary-of-product-characteristics guideline and paediatric aspects (PDF/214.1 KB)
First published: 21/01/2013
Last updated: 20/05/2019 -
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Presentation - The summary of product characteristics and older people (PDF/249.69 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Pharmacogenomics information in the summary of product characteristics (PDF/163.81 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - Generic, hybrid and biosimilar products (PDF/106.9 KB)
First published: 21/01/2013
Last updated: 04/06/2019 -
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Presentation - The summary of product characteristics of fixed combination medicinal products (PDF/208.86 KB)
First published: 04/06/2019
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.
- 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