Time to update your veterinary product information?

Time to update your veterinary product information?

From the “new” Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) came into force on 28 January 2022, the QRD template v.9 has been obligatory for all MA applications.

Furthermore, all existing SPCs, labels and package leaflets must be converted to the latest version.

Updates should be submitted as a one-off variation with assessment, VRA G.I.18. CMDv recommends grouping these variations with other G-variations affecting the product information. Update to QRD template v.9 must be finalised and implemented on the printed labelling and package leaflet before 27 January 2027.

Even if you still got time, we recommend performing these template updates continuously and not at the last minute.

Template v.9 contains a new structure with quite extensive changes to the order of sections and paragraphs in SPC, labelling and package leaflet, and updates to the text and standard terms.

Mericon has long experience with handling product information, including template updates. Do not hesitate to contact us, we would be happy to assist you!