How to prepare and review a summary of product characteristics

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This page includes guidance for pharmaceutical companies 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.

Table of contents


Training presentations

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Document(s) Language Status First published Last updated Effective Date
Presentation - SmPC training presentations user guide (English only)   2013-01-21    
Presentation - Introduction to the summary-of-product-characteristics guideline (English only)   2013-01-21    
Presentation - Section 1: Name of medicinal product (English only)   2013-01-21    
Presentation - Section 2: Qualitative and quantitative composition (English only)   2013-01-21    
Presentation - Section 3: Pharmaceutical form (English only)   2013-01-21    
Presentation - Section 4.1: Therapeutic indications (English only)   2013-01-21    
Presentation - Section 4.2: Posology and method of administration (English only)   2013-01-21    
Presentation - Section 4.3: Contra-indications (English only)   2013-01-21    
Presentation - Section 4.4: Special warnings and precautions for use (English only)   2013-01-21    
Presentation - Section 4.5: Interaction with other medicinal products and other forms of interaction (English only)   2013-01-21    
Presentation - Section 4.6: Fertility, pregnancy and lactation (English only)   2013-01-21    
Presentation - Section 4.7: Effects on the ability to drive and use machines (English only)   2013-01-21    
Presentation - Section 4.8: Undesirable effects (English only)   2013-01-21    
Presentation - Section 4.9: Overdose (English only)   2013-01-21    
Presentation - Section 5.1: Pharmacodynamic properties (English only)   2013-01-21    
Presentation - Section 5.2: Pharmacokinetic properties (English only)   2013-01-21    
Presentation - Section 5.3: Preclinical safety data (English only)   2013-01-21    
Presentation - Section 6: Pharmaceutical particulars (English only)   2013-01-21    
Presentation - Sections 7 to 10 related to the marketing authorisation; Sections 11 and 12 related to radiopharmaceuticals (English only)   2013-01-21 2015-12-21  
Presentation - The summary-of-product-characteristics guideline and paediatric aspects (English only)   2013-01-21    
Presentation - The summary of product characteristics and older people (English only)   2013-01-21    
Presentation - Pharmacogenomics information in the summary of product characteristics (English only)   2013-01-21    
Presentation - Generic, hybrid and biosimilar products (English only)   2013-01-21    

Scientific guidelines with SmPC recommendations

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Document(s) Language Status First published Last updated Effective Date
Scientific guidelines with summary-of-product-characteristics recommendations (English only)   2013-01-21 2014-02-11