Spring Intro 2023

Common reasons for RFI and feedback

RFI Reason

Common name too small Statutory warnings incorrect (such as paracetamol warnings) Statutory text on carton or immediate label too small Mock-ups include technical overlay Mock-ups not to scale Consolidated artwork file not provided Extra-statutory information too prominent (such as recycling information) Excipients of known effect incorrect Manufacturer details omitted from carton (label/leaflet) Side effect reporting details incorrect Straplines not supported by SmPC (OTC medicines) Straplines too prominent – size and colour (OTC medicines) Repetition of straplines on more than one face of the carton (OTC medicines) Branding portion of product name given undue prominence (OTC medicines) Age of child in image queried (OTC medicines)

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Self-certification changes submitted for full assessment

Change proposed Introduction of artwork for a registered pack size, where mock-up for smaller pack is approved. Design and layout similar or identical to approved artwork Change in cutter guides, dimension changes with minimum impact on carton and /or PIL layout Addition or removal of information relevant to other countries Registration of artwork for an additional manufacturing site where label and leaflet profiles are similar of identical Correction of error in Braille, repositioning of Braille Removal of information from multiple faces of carton (e.g flavour) Information swapped on end flaps Removal of new formulation flash Update to MAH details on label and PIL following variation (mock-ups not provided with variation) Correction of spelling errors

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