|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.|
|Status||draft: consultation open|
|Consultation start date||2017-04-03|
|Consultation end date||2018-10-31|
|Email address for email@example.com|
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 firstname.lastname@example.org until 31 October 2018.