New veterinary QRD template version 9.1 published

A Summary of Product Characteristics (SPC), a label and a package leaflet are established when a marketing authorisation is granted. The SPC, the label and the package leaflet (product information) must meet various requirements. The Veterinary Medicinal Products Unit uses the European templates of the European Medicines Agency (EMA) for establishing and approving product information.

The EMA has updated the veterinary QRD template from version 9.0 to version 9.1. QRD template version 9.1 complies with the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), just like version 9.0. In addition, this template also takes into account the requirements of the following European legislation:

- on veterinary medicinal products for oral administration

- on abbreviations and pictograms

- on rules on small packaging

QRD template version 9.1 contains:

- new standard sentences;

- new or more extensive advice on completing the template;

- an updated list of CVMP and CMDv guidelines.

Some headings in the template have also been adjusted, this at the request of the stakeholders involved (marketing authorisation holders). The . Under the heading ‘Current template (v.9.1.)’ you will find:

- the ‘annotated’ template, with extensive explanation in green text on how to fill in the template;

- the ‘highlighted’ template, showing the differences between version 9.0 and 9.1 in track changes;

- empty templates in Word format in all European languages.

The updated version of the template for a combined label-leaflet can be found at the bottom of the page, under the heading ‘QRD combined label-leaflet template (v.9.1.)’. Both an annotated template and empty templates in Word format are also available, in all European languages.

What are the consequences?

The EMA website also contains an . The Veterinary Medicinal Products Unit also uses this plan. QRD template version 9.1 should be used for a new authorisation application. It can also be used to submit a VRA G.I.18 to update the QRD template from version 8 to 9. This is a variation requiring assessment. If a current application for authorisation with product information in QRD version 9.0 has been started, it can still be updated to template version 9.1 during the suspension period (clock-stop period).

Variations do not have to be submitted for veterinary medicinal products that have already been authorised with QRD template version 9.0. This also applies to veterinary medicinal products that have already completed a VRA G.I.18 to update the QRD template. In the event of a future VRA in which the product information also changes, the product information can be updated from QRD version 9.0 to version 9.1.

Please submit a variation not requiring assessment (VNRA) in a timely manner to adjust the product information. The following deadlines apply:

- Regulation (EU) 2024/1159 w.r.t. oral medication, deadline 9 May 2029

- Regulation (EU) 2024/875 on abbreviations and pictograms, deadline 11 April 2029