Product information requirements

This section of the website provides information on the linguistic aspects of the product information (summary of product characteristics, labelling and package leaflet) for a medicine, the content of the information to be supplied (sets out the standard headings and indicate the most commonly used standard statements and terms in the 22 official EU languages (with addition of Icelandic and Norwegian) and defines the format and layout for the product information.

The templates are intended to provide applicants with practical advice on how to draw up the product information, but without prejudice to any final position of the European Medicines Agency, Committee for Human Medicinal Products (CHMP) and European Institutions as to the contents of the document. Similarly, the templates and guidance are without prejudice to the binding nature of the relevant legislation, or as to any legal interpretation to be given by the European Commission or the Court of Justice of the European Communities

The Working Group on the Quality Review of Documents (QRD) was established in June 1996 and is composed of representatives from Member States' national authorities, the European Commission and the Agency.

The group provides assistance to the Agency's scientific committees and to companies on linguistic aspects of the product information (summary of product characteristics, labelling and package leaflet) for medicines.

Important note on document formats: All Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with MS Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted.