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.
Presentation - Summary of product characteristics: What is it and what does it contain?
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.