From 1 October, the VMD has revised requirements for submission of mock-ups.
The changes outlined below are being adopted with the common objective of reducing administrative burden and introducing efficiencies to application procedures.
Applicants remain responsible for ensuring the labelling and package leaflet for product in the marketplace comply with the approved QRD and principles set out in VMD's Product Literature Standard.
Procedures requiring mock-up assessment
The VMD will continue to review and approve mock-ups for new product applications, including variation extension applications that result in a stand-alone marketing authorisation (MA), prior to those products being placed on the market.
The VMD will also review mock-ups for the following variation procedures:
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G.I.15.z Variation Requiring Assessment (VRA) applied for in the following scenarios:
- to introduce mock-ups for the first time prior to marketing where not submitted at the end of a new MA procedure
- to facilitate joint assessment of mock-ups between VMD and HPRA following granting of a new MA
- to assess significant changes to the design or layout of the mock-ups that are unrelated to the summary of product characteristics (SPC)
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G.I.18 VRA to align product information to the latest QRD template
What mock-ups do you need to submit
Mock-ups for all approved pack sizes need to be submitted for assessment prior to their first marketing.
Procedures no longer requiring mock-up assessment
The VMD will not routinely assess new mock-ups or annotate existing mock-ups for other variation categories, however, may request these on a case-by-case basis where we consider that the overall design and readability could be significantly affected.
If this is the case, the procedure will be closed with a condition, and you will need to submit a separate G.I.15z variation to facilitate review of the mock-ups.
Mock-ups for ongoing applications
The VMD will continue to assess mock-ups for applications that are ongoing as of 1 October where these have been requested. If you have received a request to submit mock-ups, please continue to submit these for VMD review.
