1. No Medical Product may be traded or marketed unless the information and data recorded on the internal and external card and the paper or electronic leaflet for the Medical Product are identical to the information and data for the package included in the Annex to the Marketing Approval issued for it or similar to the details approved in the State of origin if the Medical Product is exempt from obtaining Marketing Approval. The EDE shall determine the data that shall be recorded on both the internal and external card and the information leaflet for the Medical Product. 2. At least Arabic and English shall be used in the internal leaflet, whether printed or electronic, for the Medical Product, except in cases where a decision is issued by the Chairman or his delegate.
Interpretation and application must be checked against the official text and current version.