EMA: The Revised Checking Process of Mock-Ups and Specimens of outer/immediate labelling and package leaflets in the Centralised Procedure for Veterinary Medicinal Products

The Agency operated an extensive checking process of the Marketing Authorisation Holder’s (MAH) printed materials for outer and immediate labelling of centrally authorised medicinal products as well as of the printed package leaflet in all EU languages (‘mock-ups and specimens’). The process largely consisted of a detailed linguistic check of the printed materials of all authorised product presentations for all Member States, against the adopted product information annexes to the Community Marketing Authorisation (MA).