null 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