The Decree of 13 September 2023 of the Ministry of Health concerning “Amendments and additions to the Decree of 6 December 2016 concerning the updating of current fees and determination of fees for services not yet priced” was published in the Official Journal no. 250 of 25-10-2023.

Consequently, the fees for services rendered by AIFA at the request and convenience of the interested parties are updated as reported in Annex 1 to the aforementioned decree.

With regard to notifications/requests concerning grouping and worksharing, please note that the fees reported in Annex 1 refer to a single medicine and that the fee applicable to such type of applications is variable according to the number and/or type of variations entered and the number of medicines involved.

The calculation method of the fee applicable to grouping/worksharing applications remains unchanged, i.e:

• in grouping applications, all variations entered for each medicine involved are charged and, if the grouping contains more than 3 type II variations, the specific reduced rate applies starting from the third variation;
• in worksharing applications, a fee is levied for each variation included in the application, regardless of the number of medicines covered by the application, plus an administrative fee for each additional medicine included in the worksharing. If the worksharing contains more than 3 type II variations, the specific reduced fee applies starting from the third variation.

The updated fees apply to all applications or requests submitted on or after 9 November 2023.

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.

With reference to homeopathic medicinal products and to registrations of herbal medicinal products based on traditional use, the decree of the Minister of Health of 6 December 2012, repealing the decree of the Minister of Health of 21 December 2012, stipulates in Article 2 that the annual fee payable to AIFA by each marketing authorisation holder amounts to 20% of the fee laid down in Article 4, paragraph 5 of the Decree of the Minister of Health no. 53 of 29 March 2012.
 
Regarding allergen medicinal products, Article 3 of the Decree of the Minister of Health dated 13 September 2023, which amends and supplements the Decree of the Minister of Health dated 6 December 2016, states that the annual fee payable to AIFA by each Marketing Authorisation Holder shall be one-third of the fee specified in Article 4(5) of Decree of the Minister of Health No 53 of 29 March 2012.

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.