AIFA issues a guidance for Applicant/Marketing Authorisation Holders (MAHs) in the context of an application for a marketing authorisation (MA), mutual recognition procedure (MRP) or a decentralised procedure (DCP), providing recommendations on the quality of the national translations of the final approved texts (Summary of Product Characteristics, SPC; package leaflet, PL; labelling) and on how to submit the translations to the Italian Medicines Agency.

All information is available on the "Presentation of CPR, FI and Labels translations" page (see "Related Links").