Please note that all pharmaceutical companies must submit to the Italian Medicines Agency by and no later than 30 April 2023 the self-certification of the total amount of expenditure incurred in 2022 for promotional activities, net of personnel expenses employee, on the basis of the scheme approved with the Decree of the Minister of Health dated 23.04.04 and pay, by the same date on a special fund set up at the Agency, the relative contribution of 7% pursuant to paragraphs 17 and 18 of art. 48 of law 326/2003, and of paragraph 1 of art. 11 of law 175/2021.
The self-certification must be sent to the following PEC address protocol@pec.aifa.gov.it indicating in the subject the reason "Self-certification 7%" and the name and SIS code of the pharmaceutical company.
Source: AIFA