On October 9, 2019, the Italian Medicines Agency (“AIFA”) issued an information notice to provide useful information to medicine marketing authorisation holders (“MAH(s)”) on the obligation to notify AIFA of any temporary or permanent interruption in the marketing of medicines (“AIFA Note”).
This obligation for the MAHs is provided for by Article 34, Paragraph 6, of Legislative Decree no. 219 of April 24, 2006 (“Code of Drugs”), as amended by Decree Law no. 25 of April 30, 2019 (Decree Calabria, converted into Law no. 60 of June 25, 2019).
Specifically, Article 34, Paragraph 6, establishes that:
the MAH shall notify AIFA about the temporary or permanent interruption in medicine marketing in Italy no less than four months before the interruption;
the term of four months before the interruption in marketing does not apply where the interruption is due to unforeseeable circumstances or to reasons of product safety.
This communication is important because the interruption in marketing may lead to a state where there is a deficiency in the supply of the medicinal product which occurs when the availability of a medicine does not meet the demand at the national level.
Mandatory contents of the communication
The AIFA Note implements Article 34, Paragraph 6, by providing details on how this communication should be undertaken by the MAHs.
In particular, according to the AIFA Note, the communication must report certain mandatory information, including the following:
the trade name of the medicine, its active substance(s), the pharmaceutical form and strength, the packaging, the number of marketing authorisations and the corporate name of the MAH;
the date of the interruption in marketing or the anticipated shortage situation;
the estimated duration of the shortage situation and the date of the intended restarting of the marketing in the event of a temporary interruption.
Meaning of “unforeseeable circumstance”
The AIFA Note lists, by way of example, some events that may be qualified as “foreseeable” (i.e., equipment replacement) and others that may be qualified as “unforeseeable” (i.e., quality defects) and specifies the cases in which the circumstance of the unforeseeability of the event shall be documented.
As specified above, in the case of interruption due to unforeseeable circumstances, the four-month term provided for by Article 34, Paragraph 6, does not apply. However, the communication of such unforeseeable circumstances and of the subsequent interruption in the medicine’s marketing shall be transmitted without delay with all the required mandatory elements.
Failure to notify or late communication: penalties
The Code of Drugs (Article 148) provides for a fine in cases where there is: (i) failure to notify, and (ii) late communication.
An incomplete communication, i.e,. without one or more of the mandatory elements, unless a timely integration is made, is equivalent to the failure to notify, thus resulting in the relevant fine.
The maximum fine for failure to notify is Euros 18,000. While, in the case of late communication, the sanction of Euros 6,000 is applied.
Moreover, the AIFA Note reminds us that the communication of false declarations to public authorities is considered a crime and entails the loss of the benefit obtained through the communication itself, i.e., the exemption from the payment of the fine provided for by the mentioned Article 148 of the Code of Drugs.