With the update of veterinary regulation (EU 2019/6), QRD template version 9.1 has replaced version 9.0, which was published in October 2024. From 10 March 2025, applicants must use template version v.9.1 for new marketing authorisation applications. If the MA procedure has already started with template v.9.0, the applicant can switch to v.9.1 during the procedure if the revised product information using the new version of the template can be submitted with the responses to the D120 LoQ or with the responses to the D180 LoOI.
MAs that have not yet been updated under variation G.I.18 (QRD v.9 alignment) must be brought in line with template version 9.1 by 29 January 2027. For veterinary medicinal products already aligned with version 9.0 through a G.I.18 variation, there is no specific deadline for updating to version 9.1. This update can be made via any VRA (Variation Requiring Assessment) affecting the product information, provided that no new or additional data requiring assessment is needed. If new or additional quality-related data must be submitted, a dedicated VRA should be used. Single changes may also be implemented through the dedicated VNRA-categories (e.g. abbreviations and pictograms) and in line with the guidance and standard sentences included in QRD v.9.1. See more details for VNRA cases below.
Template v.9.1 Overview
- Template v.9.1 is available in all EU languages.
- Supports Regulation (EU) 2019/6, and implementing Regulations 2024/1159 (oral use), 2024/875 (abbreviations/pictograms), and 2024/878 (small immediate packaging).
- Includes:
- New standard statements for oral products (SPC sections 3.8 & 3.9).
- Labelling/leaflet guidance on pictograms, abbreviations, and small packaging.
- Expanded guidance (SPC sections 3.3 contraindications, 3.5 adverse events, 9. SPC revision date).
- Updated texts for MAs under limited markets or exceptional circumstances.
- New pharmacovigilance statement for centrally authorised products (Annex II).
- Updated list of CVMP and CMDv guidance.
- Expanded guidance text in many sections to improve clarity for applicants and regulators (e.g. contraindications, special precautions for use, adverse events, data of last revision, contact details).
- New green explanatory text and standard statement regarding specific pharmacovigilance requirements in Annex II (only for CAPs).
- Amendments to the standard texts for MAs granted for limited markets and under exceptional circumstances under the GtAin accordance with the requirements of Art. 23(2) and 26(2) of the Regulation.
New Implementing Regulations – Abbreviations, Pictograms and Small Immediate Packaging
- Pictograms and abbreviations: May be used to replace the written information on immediate packaging and outer packaging referred to in Article 10(1) and Article 11(1) of Regulation (EU) 2019/6.
- VNRA C.10.d replacement of information on the immediate or outer packaging by an abbreviation or pictogram; replacement of an existing abbreviation or pictogram
- Products may be placed on the market until 11 April 2029 even if the pictograms and abbreviations used in their labelling do not comply with this Regulation.
- No other abbreviations and pictograms than those listed in the Annexes to this Regulation shall be used to replace that written information.
- Abbreviations and pictograms used on the labelling must be explained in full text in the package leaflet.
Small immediate packaging: Regulation 2019/6 – Article 12
- VNRA C.10.e – alignment of labelling of the immediate packaging with the requirements laid down in Article 12 of Regulation (EU) 2019/6
- Products may be placed on the market until 11 April 2031 even if the information contained on their labelling as regards immediate packaging units is not in compliance with this Regulation.
- all containers with nominal volume up to and including 50 ml use labelling for small immediate packaging.
- shall contain the following information and shall contain no information other than:
- (a) the name of veterinary medicinal product;
- (b) the quantitative particulars of the active substances;
- (c) the batch number, preceded by the word ‘Lot’;
- (d) the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’.
How is the QRD template update done in practice?
The QRD template update is submitted as a variation type VRA-S G.I.18. If MA is updated from version 8.2 to the new template, the update according to template version 9.1 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.
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.
Timing of submissions:
- All product information texts must be updated. Texts according to template version 9.1 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 from 8.2 to the new template version 9.1 is quite a big one: this update impacts all printed package materials.
- If you are suggesting 12 month implementation schedule in your 9.1 variation application, be sure to submit your variation during July 2025 at the latest. For submission after this, the implementation timeline is less than 12 months after approval of the variation for your packaging 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 remaining time before the deadline.
Where else might QRD template updates be needed?
Updates according to template version 9.1 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 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!
Authors:
Elina Krannila
Senior Regulatory Affairs Expert
Elina has been working at Medfiles since 2011. She is part of the Veterinary Medicines Team, where she handles regulatory tasks related to marketing authorisations (MA) of veterinary medicines. The team’s daily work includes MA applications and lifecycle management for EU veterinary products approved through centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP), and national (NP) procedures. The team is well versed in veterinary legislation and relevant regulatory guidance, including the EU Veterinary Medicinal Products Regulation, UK VMD guidance, and US FDA guidance.
Annika Stigell
Regulatory Affairs Expert
Annika has been working at Medfiles since 2017. She started her regulatory career at Fimea (Finnish Medicines Agency), and has worked with pharmaceutical regulatory tasks for more than a decade. She is part of Medfiles’ veterinary and human medicines team, where she handles regulatory tasks related to marketing authorisations (MA), as well as national Scandinavian translations and labelling reviews.
Free WEBINAR: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system
In our webinar you will learn about the main changes and requirements brought about by the Veterinary Medicinal Products Regulation. In the webinar we will discuss variation management and the relationship between pharmacovigilance systems and the related quality measures.
