Each year, holders of Marketing Authorisations (MA) provided by the AIFA, must pay an annual fee for each for each product with marketing authorisation as of 31 December the previous year. Fees are paid at the end of July, with exact deadlines confirmed near the time. Experts in the Italian regulatory system, Regulatory Pharma Net say:
“The annual fee has to be paid through the online system available on the AIFA institutional portal (AIFA Front-End), via the specific Company access.
A fee reduction is applied for Small-medium enterprises (SMEs) upon submission of the appropriate documentation.
The fee is not due for MAs registered through centralised procedure.”
The annual fee for AIFA Marketing Authorisations (MA) valid till 31 December 2017 is due on 31 July 2018.
To read more about product licensing in Italy, please click here.