Implementation of new QRD templates
The product information must comply with the QRDv9 before the 30th of January 2027.
The new versions of the QRD templates (v.9) taking into account the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6 are available here:
German templates for PDF with unlimited access (PDF/UA)
The BASG has updated the accessible versions, which are available for download at
National Requirements
According to the Austrian Fachinformationsverordnung (SPC decree, BGBl. II Nr. 175/2008) and the Austrian Gebrauchsinformationsverordnung (Package Leaflet decree, BGBl. II Nr. 176/2008) the product name must be completed with the target species or with the term “for animals” and must therefore be stated as such in SPC and package leaflet.
The deletion of the target species from the name of a medicinal product in the framework of a QRDv9 implementation is not permitted!
Please note that the final national product information texts have to be uploaded at the end of a procedure via the eService “Marketing Authorisation & Lifecycle Management of Medicines” for the respective procedure number, separated into SmPC, package leaflet and labelling.
For further information please refer to FAQ online services - BASG.
Based on the final package leaflet, an accessible PDF document has to be created and also uploaded via eService.
For further information please refer to Accessible patient information leaflet - BASG, resp. FAQ Accessible patient information leaflet - BASG.
CMDv - call for early submission and statistics
Please find the call for submitting the variation to update the product information according to QRDv.9 and the current statistics on these variations from the CMDv here:
Dear Marketing Authorisation Holders,
According to article 152 of the Regulation (EU) 2019/6, all marketing authorisation of VMPs granted according to the Directive 2001/82/EC, as amended, require an update of the product information in line with the QRD template version 9. The MAs should be updated before the 30th of January 2027, after which all products on the market should have product information compliant with QRDv9.
With reference to the tabulated data below, the % of currently updated MAs is not sufficient to guarantee that all VMPs will have an updated marketing authorisation before the 30th of January 2027.
The % of G.I.18 VRAs submitted (currently awaiting or under review) is also critically low. This low number of VRA applications submitted in the Member States will not allow for all changes to be implemented in the EU market before the 30th of January 2027.
As a matter of urgency MAHs are kindly invited to plan for and start submitting the required G.I.18 VRAs to the NCA/RMS as soon as possible, to guarantee compliance with Article 152 of Regulation 2019/6 by the required deadline. To speed up submission and processing time for these variations the MAHs are furthermore encouraged to submit the VRA G.I.18 as stand-alone applications.
In addition, MAHs are kindly recommended to provide, as far as possible, their schedules for remaining submissions to the relevant national competent authorities to support the timely allocation of necessary resources.
Consequently, I kindly invite you to circulate this e-mail amongst the members of your associations.
Laetitia Le Letty
Cheffe de mission affaires européennes et internationales – Présidente du CMDv
Head of European and international affairs – Chair of CMDv
Tel : (+33)6 10 25 60 72 – (+33)2 99 94 78 31
Agence nationale du médicament vétérinaire (ANMV) – French agency for veterinary medicinal products
AGENCE NATIONALE DE SÉCURITÉ SANITAIRE de l’alimentation, de l’environnement et du travail – FRENCH AGENCY FOR FOOD, ENVIRONMENTAL AND OCCUPATIONAL HEALTH AND SAFETY
14 rue Claude Bourgelat – PA de la Grande Marche – Javené - CS 70611 – F-35306 FOUGERES Cedex
www.anses.fr
Further information:
https://www.hma.eu/veterinary-medicines/cmdv
