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null Perforated blisters

Perforated blisters

What information should be given for the perforated blister in the application and in the product information?

Perforated blisters should be registered as unit-dose blisters in accordance with the EDQM definition for the standard term ”unit-dose blister “. In the application form, the summary of product characteristics, the package leaflet and on the outer carton the pack size should be stated as e.g. “20 x 1 tablets”. All the labelling information required for the blister packs should appear on each unit dose presentation.

14 Nov 2016