Advice on implementing regulation (EU) 2024/1159

News item | 27-05-2025 | 11:00

The European Medicines Agency (EMA) published a new version of the QRD template in November 2024: QRD template version 9.1. You can find the new QRD template version 9.1 of the EMA here.  New advice and standard sentences have been added to QRD template version 9.1 for the following European regulations:

• Regulation (EU) 2024/1159 on veterinary medicinal products for oral administration to food-producing animals via routes other than medicated feed
• Regulation (EU) 2024/875 on abbreviations and pictograms
• Regulation (EU) 2024/878 on regulations for small immediate packaging units

Marketing authorisation holders must ensure that the product information of existing authorisations complies with the implementing regulation (EU) 2024/1159 on veterinary medicinal products for oral administration to food-producing animals via routes other than medicated feed by 9 May 2029 at the latest. The MEB Agency (VMPU) has received reports that marketing authorisation holders are not sure how to approach the implementation.
 

How do I approach the implementation?

When filing a variation to update the product information to QRD template version 9.1, the implementing regulation can be implemented immediately, if only standard sentences from QRD template version 9.1 are used. 

If an update for a veterinary medicinal product has already been filed for QRD 9.0, the marketing authorisation holder must file the Variation Not Requiring Assessment (VNRA) C.10.f “Alignment of the product information with the requirements laid down in article 9 of Commission Delegated Regulation (EU) 2024/1159” to add the necessary standard sentences to comply with the implementing regulation. 

A Variation Requiring Assessment (VRA) is only necessary if claims are being added to the SPC stating, for example, that a veterinary medicinal product for oral administration to food-producing animals can be used mixed with certain biocidal products or feed additives in drinking water/liquid feed, as this must be supported with data.

For more information, read the implementation plan of the EMA for QRD version 9.1.
 

What products does this apply to?

The delegated regulation (EU) 2024/1159 on veterinary medicinal products for oral administration to food-producing animals via routes other than medicated feed applies to the following veterinary medicinal products:

• Antimicrobial and antiparasitic veterinary medicinal products that are administered through or over solid feed to food-producing terrestrial animals.
  A standard sentence has been added in QRD 9.1 in SPC section 3.9. This standard sentence can be added to the SPC with an update to QRD 9.1 or with a VNRA.
• All veterinary medicinal products that are administered via drinking water or liquid feed.
  This applies for all medication administered to food-producing animals via drinking water or liquid feed, including vaccines. Standard sentences have been included in QRD template version 9.1 for this purpose in SPC section 5.1: one that can be used to display available information (from studies) on incompatibilities in combination with standard sentences from the relevant guideline,  and another that indicates that there have been no studies and that therefore no multiple products (including biocidal products and additives) can be mixed in the drinking water/liquid feed. The standard sentence that no information is available can be added to the SPC with an update to QRD 9.1 or with a VNRA. The standard sentence on whether or not the veterinary medicinal product can be mixed in the drinking water/liquid feed with specific biocidal products, feed additives or other substances can only be added to the SPC by filing a VRA with supporting data.