With the veterinary regulation (EU 2019/6), also the QRD template 9.0 has been updated and will be used for all new marketing authorisations. For existing marketing authorisations, texts according to QRD template version 8.2 are allowed until the end of the transition period. However, by 29 January 2027, the product information texts of all veterinary medicines in Europe must be accordant with template version 9.0. Although the deadline may seem far in the distance, now is a good time to make a plan on how to implement the template update on time for all your products.
Why plan the QRD template update now?
- All product information texts must be updated. Texts according to template version 9.0 must be implemented in all printed materials by 29 January 2027, which means that after that date, a veterinary medicine cannot be released on the market with text according to template version 8.2. The leap to the new template version 9.0 is quite a big one: this update impacts all printed package materials.
- Variations take time. Making the update, submitting it and having it approved all take time. The QRD update is submitted as a VRA-S variation, which takes approximately 6 months, additional questions included. For marketing authorisations in the centralised procedure, EMA must be notified of the variation two months before submission, and at this point, EMA will provide more detailed instructions to the marketing authorisation holder. After a positive opinion by CVMP, the approval of the European Commission may take another 1 to 2 months. In addition, the national phase for products in DCP and MRP procedures takes its time.
- Variations may pile up. In 2026, the authorities may have quite a few of these variations on their table, which means that submissions should not be left to the last minute. If you have lots of products in your portfolio, it may be wise to divide the workload for the four years before the deadline.
How is the QRD template update done in practice?
The QRD template update is submitted as a variation type VRA-S G.I.18. The update according to template version 9.0 must always be done as a variation of its own, and it can’t be done as a part of a text variation. But the variation can be grouped – and it may be smart to do so – with another type G variation. However, it can’t be grouped with VNRA variations.
Template version 9.0 has already been updated after its publication, and the last update was in November 2022, but the update did not change the template version number. So, before you start updating the texts, be sure to use the latest version from the EMA’s website. There, you can also find the updated Appendix I with the required contact details for reporting adverse reactions, which you can then easily add to the package leaflet.
Finally, don’t forget to check the latest national requirements for the labelling and package leaflet. This guidance also provides instructions on the additional information acceptable on outer packages (Article 13), such as information about local representatives.
Where else might QRD template updates be needed?
Updates according to template version 9.0 may also be needed in SRP processes. In this case, the texts in countries already in the process must be updated before the submission. Therefore, the need for text updates should be considered well in advance.
With the new veterinary regulation (EU 2019/6), the texts of national marketing authorisations in United Kingdom of Great Britain and Northern Ireland no longer follow the same templates as the marketing authorisations in the EU, but there is a separate national template for the summary of product characteristics and the QRD texts. The QRD texts for these national marketing authorisations include both the package leaflet and the labelling texts. These templates are used for all national marketing authorisations in these countries. The transition period for currently valid marketing authorisations transferring to this national template is yet to be established. It may be good to keep an eye on any news from the authorities.
Do you need help or extra hands for your text updates? Our experienced veterinary medicines team regularly monitors authority guidelines and communication and participates in training on current topics. We are happy to help you!
