Working Group on Quality Review of Documents

The Working Group on Quality Review of Documents (QRD) provides assistance to the Agency's scientific committees and to companies on linguistic aspects of the product information for medicines (summaries of product characteristics, labelling and package leaflets).

The QRD's tasks include:

• ensuring linguistic clarity, consistency and accuracy of the product information;
• verifying the terminology used in translations and their consistency with the original versions;
• promoting legibility of product information;
• reviewing and updating templates for opinions of the scientific committees and for product information, to ensure compliance with European Union (EU) rules on medicinal products and taking practical experience into account;
• contributing to the development of a common understanding on the implementation of legislation and guidelines in relation to product information and labelling.

Meeting dates

The QRD's meeting dates are available in this document:

• QRD plenary and sub-group meeting dates

Composition

The QRD is composed of two European experts per Member State, one for human and one for veterinary medicinal products, selected by the national competent authorities. They all have appropriate expertise in regulatory and linguistic areas, as well as in product information and labelling for medicines.

In addition, one representative each from the European Commission, the Translation Centre for the Bodies of the EU (CdT) and the Agency secretariat participates in the work of the QRD.

The Agency chairs the group and provides secretarial support.

Members

Below (in alphabetical order of surname) are the current members of the QRD. The members' declarations of interests are available in the European expert list.