Clarification of AIFA Administrative Sanctions
The law recognises in AIFA - as the Drug Regulatory Authority - the power to apply pecuniary sanctions in the event of violation of specific sector regulations (see, among these, the sanctions provided for in Article 42(1) of Legislative Decree No. 200/2007 and Article 2(7) of Legislative Decree No. 17/2014).
But how exactly does this process work?
Here are the main steps involved.
The first phase of the process
Following a challenge by AIFA, the person concerned may decide to:
– Paying the penaltyThe person concerned may choose to pay the penalty in a reduced amount, within 60 days from receipt of the objection.
– Contesting the sanctionIf the person concerned considers that the sanction is unjustified, he/she has 30 days to send defence papers, documents and a request for a hearing.
Hearing of the parties: Hearing
After receiving the complaint, the competent office of AIFA will examine the file, evaluate the defence and, if necessary, hear the person concerned.
Finalisation of the file: the decision
Once the file has been completed, the relevant office of AIFA will make a decision, and if it considers:
– the finding to be well-founded: the competent office determines the amount of the sanction and orders its payment;
– the unfounded findingorder is issued.
Execution of the sanction
The payment order constitutes an enforcement order. If payment is not made within 30 days (60 days for residents abroad), AIFA will initiate compulsory collection through the Agenzia delle Entrate - Riscossione.
Opposition by the interested party
It is always possible to oppose the injunction order before the ordinary court.
⬇️ Below is an illustrative diagram of the entire process.
You can read the AIFA press release of 6 June.
More news about AIFA
Pharma Value is always at the forefront in disseminating the main news concerning the Italian Medicines Agency, such as the Update on the new CSE (Scientific and Economic Commission) and the AIFA reorganisationon the basis of the amendments requested by the State-Regions Conference and the Council of State.
In another article we also wrote about the "Technical Table for the revision of AIFA Notes and Therapeutic Plans (PT)" in support of the Scientific and Economic Commission for Medicines (CSE).
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