EMA: Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure

Since February 2007 the European Medicines Agency (EMA) has been operating an extensive checking process of the marketing-authorisation holder’s (MAH) printed packaging materials for outer and immediate labelling of centrally authorised medicinal products as well as of the printed package leaflet (‘mock-ups and specimens’).