EMA releases guidance on preparing product characteristic summaries

Published: 27-Feb-2013
Regulatory

Detailing the information required for each SmPC section


The European Medicines Agency (EMA) has published guidance to help pharmaceutical companies prepare and review summaries of product characteristics (SmPCs) for human medicines. It details information required for each SmPC section, plus background information, for instance on therapeutic indication, pharmacodynamic properties and undesirable effects sections.

The guidance ‘is intended to enable companies to make sure that the information in SmPCs is of high quality when they submit them to the agency’ during marketing authorisation applications, EMA said. These summaries are kept updated with new efficacy or safety data and are the basis for package leaflets informing patients about the medicines.

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