Change to procedure for joint label assessment for new Marketing Authorisation applications
From 13 May 2024 we are introducing a change to the procedure for new Marketing Authorisation (MA) applications, where a joint assessment of labels is requested.
Joint assessment is the term used for a procedure where the Irish National Competent Authority (HPRA) and VMD will collaborate on the assessment of a shared mock-up, for use on veterinary medicines marketed in their countries.
For new MA applications, upon completion of the assessment phase, applicants are asked to submit mock-ups reflecting the approved QRD text for VMD assessment.
From 13 May, if you respond to this request advising that joint assessment is required, the new MA procedure will be closed, and a condition applied to your MA to submit mock-ups for assessment prior to marketing.
You will then be responsible for submitting a parallel national G.I.15.z variation requiring assessment (VRA) to both the VMD and HPRA to facilitate joint assessment of your mock-ups. This variation is subject to the appropriate fee.
Alternatively, if you respond to this request by submitting mock-ups and advising that joint assessment is not required, the new MA procedure will proceed with a VMD assessment of mock-ups, independent of HPRA.