Support from knoell for QRD9
Calling all companies with EU Marketing Authorisations! The clock is ticking towards January 2027 - when the QRD9 template must be fully implemented for the SPC, labelling and package leaflet texts for all veterinary medicinal products.
It would be easy to make the mistake of waiting too long to manage the transition comfortably, and as the saying goes – ‘failing to plan is planning to fail’! The most recent CMDv meeting report states that the number of QRD9 update variations submitted so far is critically low.
Getting knoell on board can give you peace of mind: our regulatory affairs team are perfectly positioned to step in and support with this work. With decades of cumulative experience and a keen eye for detail, our well-organised, co-operative team can help you plan the best way to tackle your QRD9 workload. We can manage the whole process, or tailor support to meet your company's specific needs:
- Updating texts to the new QRD template, in all EU languages;
- Arranging translations of new wording, if needed;
- Revising adverse events information in SPC section 3.6/PL section 7 - in line with recent pharmacovigilance data;
- Preparing, submitting and overseeing the G.I.18 Variation Requiring Assessment;
- Reviewing updated mock-ups and other national administration.
Get in touch with us if you’d like to know more.
