The SmPC can be viewed as a contract between the marketing authorisation (MA) holder of a medicinal product, who drafts the document, and the regulatory agency, who reviews the document. It contains all the relevant product-specific efficacy and safety information and thus provides the very basis for safe and effective use of a medicinal product. It also provides the reference of information for the package leaflet and sets the limits on what can be legally communicated about the medicinal product in advertising.
Due to its important function, it is paramount for regulators to ensure every SmPC is of very high quality, both in terms of scientific information and lingual clarity. National competent authorities review SmPCs on the basis of the European Commission’s 2009 guideline on the SmPC. This document specifies the SmPC’s overall structure, and outlines how information should be presented in each section. In addition, the language in which the SmPC is written should be clear and concise, with consistent use of terminology throughout. Particularly in the light of EMA’s ongoing digitisation efforts, the importance of consistent use of terminology cannot be stressed enough.
Compliance with the standards set in the EC guideline is mandatory, in order to ensure optimal use of the medicinal product. It is often forgotten that it is not only health care professionals who rely on information from the SmPC. Equally so do patients who obtain information on their medicines from the package leaflet, which essentially represents a ‘lay language translation’ of the SmPC.
The EMA has recently updated twenty distinct presentations on certain SmPC sections and sub-sections. Better communication of the Agency’s expectations and what it regards to be essential should help achieving high quality SmPCs upon first MA submission. These documents, alongside equally helpful presentations which have not been updated, are collectively stored here. Our labelling team at EUDRAC has extensive experience in writing SmPCs, both as standalone projects or within the context of preparing an entire MA application. For more information please contact one of the EUDRAC offices.