The European Medicines Agency operates a checking process of the printed materials used in the packaging and labelling of centrally authorised medicines.
The aim of this checking process is to improve the quality of the printed materials that patients and healthcare workers receive with a medicine. This includes the outer and inner packaging of the medicine, and the printed package leaflet.
The Agency reviews mock-ups and specimens of the packaging and labelling of medicines authorised via the centralised procedure, both before the medicine is marketed and following certain changes to the medicine's authorisation:
- Mock-ups are copies of the flat artwork design in full colour, presented so that, following cutting and folding where necessary, it provides a replica of both the outer and immediate packaging so that the three
dimensional presentation of the label text is clear.
- Specimens are samples of the actual printed outer and immediate packaging materials and package leaflet, i.e. the 'sales presentation'.