Payment of fees and annual duties

As of 1 April 2020 the fees indicated in Annex 1 of Ministerial Decree dated 6 December 2016, concerning the update of existing fees and the pricing of not-yet-charged services, are automatically updated on the basis of the ISTAT (Italian National Statistical Institute) index of the cost of living referred to December 2019, according to article 3, paragraph 1 of the same decree.

The updated fees shall apply to all requests and applications submitted as of 1 April 2020.

Fees paid before 1 April 2020 relating to requests or applications submitted from that date onwards must be supplemented by the difference between the amount already paid and the new amount introduced.

Fee payment forms

Annual fee

As established by AIFA Board of Directors’ decision no. 21 dated 30 May 2012, marketing authorisation holders (MAHs) are required to pay an annual fee for each marketing authorisation (6 digit code) valid at 31 December of the previous year. Such fee should be paid to the Italian Medicines Agency through the online payment system available on the institutional website no later than July.

Self-certification of compliance for micro, small and medium-sized enterprises

In order benefit from the reductions established introduced by article 4, paragraph 6, of Health Ministry decree no. 53 dated 29 March 2012, by paragraph 3 of resolution no. 21 of 30 May 2012 as well as by article 6, paragraphs 1 and 2, of Health Ministry decree dated 6 December  2016 for public bodies and micro, small and medium-sized enterprises, referred to in Commission Recommendation 2003/361/EC, the company shall demonstrate compliance with the requirements established therein, by producing appropriate documentation or a self-certification pursuant to articles 46 and 47 of Presidential Decree 445/2000, using the available forms.

To benefit from the reductions in the current year, the documentation or self-certification  should refer to information/data relating to 31 December of the previous year.
The above-mentioned documentation or self-certification must be sent to the certified e-mail address  before or when the request for reduction is submitted, by specifying whether the documentation (a) or self-certification (b) is being sent in the subject matter.

If conditions are still met, such documentation or self-certification must be re-submitted for the following year by 30 June, under penalty of forfeiture from the benefit.
The Italian Medicine Agency reserves the right to carry out appropriate controls aimed at verifying that the company in question actually possess the self-certified requirements.