This page includes guidance for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines.
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.
Table of contents
Scientific guidelines with SmPC recommendations
|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|
- 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