The Italian Medicines Agency announces the publication in the Official Gazette, General Series n. 39 of 16/02/2021, of the Determinazione DG n. 164 of 09/02/2021 of "Definition of the classification for supply and of specialists for medicinal products containing the active substance diclofenac sodium, pharmaceutical form "gel", indicated in the treatment of actinic or solar keratosis (AKs)".

The Technical-Scientific Commission, in the meeting of the Meeting of 9, 10 and 11 December 2020 Minutes no. 35, decided to harmonize the classification for supply and definition of specialists for medicinal products containing the active substance diclofenac sodium, pharmaceutical form "gel", indicated in the treatment of actinic or solar keratosis (AKs) as follows: Medicinal products under restricted medical prescription, which may be delivered to the public on prescription from hospitals or specialists (RRL)/specialist: dermatologist.