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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'.
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