Quality review of documents (QRD) template ‘Particulars to appear on the immediate package – combined label and package leaflet’ for veterinary medicinal products authorised via the centralised, mutual recognition and decentralised procedures.

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Download document Quality review of documents (QRD) template ‘Particulars to appear on the immediate package – combined label and package leaflet’ for veterinary medicinal products authorised via the centralised, mutual recognition and decentralised procedures.
Reference number EMA/195158/2017
Status draft: consultation open
First published 2017-04-03
Last updated 2017-04-03
Consultation start date 2017-04-03
Consultation end date 2018-10-31
Email address for submissions qrd@ema.europa.eu

Summary

This template is designed for applicants who plan to put all labelling and leaflet information on the immediate packaging instead of printing a package leaflet. This is in line with Article 61(1) of the Veterinary Directive. The aim is to harmonise existing initiatives at the national level (driven by the need for such a template) and to ensure that critical elements are prominently located on these types of packs. An 18-month pilot phase will enable applicants and competent authorities to gain experience in using the template within pre- or post-authorisation applications. The aim after the pilot is to incorporate the combined label-leaflet within the main set of QRD veterinary templates. Please send comments using the comments form to qrd@ema.europa.eu until 31 October 2018.