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

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)   21/01/2013 11/02/2014