QRD template: EMA template for product information

The Working Group on Quality Review of Documents (QRD) brings together EMA, national competent authorities and the Commission to keep product information consistent across the EU. Its product information templates set the order, headings and standard statements for Annex I (the summary of product characteristics), Annex II (manufacturers, conditions of the authorisation and the risk management plan), Annex IIIA (labelling) and Annex IIIB (package leaflet). The templates exist in all official EU languages plus Norwegian and Icelandic, with annotated versions that explain what each section must contain, and appendices that list standard terms, for example the statements for storage conditions and the headings that may be omitted. The content requirements themselves come from Articles 11, 54, 55 and 59 of Directive 2001/83/EC; the template is how those requirements are presented.

Use of the QRD template is mandatory for centrally authorised products, where EMA's QRD review checks every language version before the CHMP opinion and after each variation that touches the text. The CMDh has adopted templates for mutual recognition, decentralised and national procedures that follow the same structure, and most national authorities require them. Templates are revised from time to time, and each revision comes with a transition period during which holders bring their product information into line, usually at the next variation affecting the text rather than through a stand-alone submission.

What goes wrong: product information drafted on an old template version is sent back for reformatting, which delays the opinion or the national phase; translators change standard statements that must be reproduced verbatim from the language version of the template; the leaflet headings drift from the template because they were adapted for readability; and companies with large portfolios cannot say which products are on which template version, so a template update becomes a portfolio-wide audit. For generics the problem is doubled, because the text must also follow the reference product's SmPC wherever it is not patent-protected.

Under the new pharma package (not yet in force), the leaflet must be provided on paper and electronically, and Member States may allow electronic-only leaflets, which will need the structured ePI standard alongside the current template; see ePI changes.