SPC, label and package leaflet of veterinary medicinal products will change

The rules about the appearance of an SPC, label or package leaflet for veterinary medicinal products will change on 28 January 2022. All applications submitted on or after 28 January 2022 must comply with the new template. This is the instruction issued by the European Medicines Agency (EMA).

The changes are the consequence of the new Veterinary Medicinal Products Regulation, which is coming into effect on 28 January 2022.

New QRD template

The new rules are included in the new QRD template v.9. The template and an overview of the changes in this new version can be found here. At the moment only an English version of this document is available, with a Dutch version following in October.

Existing SPCs, labels and package leaflets

The QRD template v. 9.0 is obligatory for all applications that are submitted on or after 28 January 2022. What is more, all existing SPCs, labels and package leaflets must be converted to this new version before 29 January 2027 by means of a one-off variation with assessment. This is stated in the CMDv QA document on transitional arrangements.

Label-package leaflet QRD template

The European Medicines Agency (EMA) is also expected to adopt a combined label-package leaflet QRD template in the fourth quarter of this year. You should use this whenever no package leaflet is available and when all the information has to be stated on the outer packaging.

About the new Veterinary Medicinal Products Regulation

The new Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and Regulation (EU) 2019/4 on medicated feed are both coming into effect on 28 January 2022. A great deal will change as from next year due to the implementation of the Veterinary Medicinal Products Regulation (VMR). The development and further detailing of the VMR have been in progress since its publication in January 2019.

The further detailing of the VMR at European level will take place in the form of delegated and implementing regulations. Since the last update, 3 new underlying implementing regulations have been adopted, which are being drawn up by the European Commission. The other regulations are to be adopted later this year, with a number only being adopted in 2022 or later.

During the coming months the Veterinary Medicinal Products Unit will organise various online information meetings to answer your questions about the Veterinary Medicinal Products Regulation. The first meeting will be held in the afternoon of Tuesday 28 September 2021.