Art. 118: Se la pubblicità presso il pubblico e’ effettuata in violazione delle disposizioni del presente decreto, il Ministero della salute:
- a) orders the immediate cessation of advertising;
- b) orders the dissemination, at the offender's expense, of a correction and clarification press release, according to methods established by the same Ministry, without prejudice to the provisions of article 7 of law no. 175.
Article 119: Se l’informazione promozionale presso gli operatori sanitari e’ effettuata in violazione delle disposizioni e dei criteri e delle direttive adottate dall’AIFA ai sensi del comma 2, l’Agenzia stessa:
- a) orders the immediate cessation or suspension of the promotional information;
- b) orders the dissemination, at the offender's expense, of a correction and clarification press release, the drafting of which will be handled according to the methods established by AIFA. This press release may be inserted by AIFA in the Bulletin of information on drugs and on the institutional website of the same and, by and at the expense of the Company, on the latter's website or even in national newspapers.
- 7. The provisions of paragraphs 1, 3, 4 and 5 and the provisions of articles 121 and 125 are applied without prejudice to what is regulated by the regions pursuant to paragraph 21 of article 48 of the decree-law of 30 September 2003, n. 269, converted, with amendments, by law 24 November 2003, n. 326.
Article 120: AIFA may, at any time, with a motivated provision, also taking into account the guidelines referred to in paragraph 2 of article 119, prohibit or suspend the disclosure of the documentation referred to in paragraph 1, if it considers it to be in conflict with the provisions and principles of this decree.
Article 127: In caso di pubblicità irregolare svolta presso gli operatori sanitari, l’AIFA adotta, se del caso, i provvedimenti indicati all’articolo 118, comma 13.
Art. 147: Chiunque, in violazione dell’articolo 123, comma 1, concede, offre o promette premi, vantaggi pecuniari o in natura, e’ punito con l’arresto fino ad un anno e con l’ammenda da diecimila euro a centomila euro. Le stesse pene si applicano al medico e al farmacista che, in violazione dell’articolo 123, comma 3, sollecitano o accettano incentivi vietati. La condanna importa la sospensione dall’esercizio della professione per un periodo di tempo pari alla durata della pena inflitta. In caso di violazione del comma 2 dell’articolo 123, si applica la sanzione dell’ammenda da quattrocento euro a mille euro.
Article 148:
- 16. Chiunque viola il disposto del comma 8 dell’articolo 125 soggiace alla sanzione amministrativa da diecimila euro a cinquantamila euro. In caso di violazione delle restanti disposizioni dello stesso articolo 125 si applica il disposto dell’articolo 127.
- 17. Whoever violates the provisions of article 126 is subject to an administrative fine ranging from fifty thousand to three hundred thousand euros.
- 18. Violation of the provisions of this decree on advertising to healthcare professionals entails the application of an administrative fine ranging from two thousand six hundred to fifteen thousand six hundred euros.
- 19. For medicines included in the list of medicines which can be dispensed at the expense of the National Health Service, the violation referred to in paragraph 18 may also lead to the suspension of the medicine from the aforementioned list for a period of time from ten days to two years, taking into account the seriousness of the fact. The suspension provision is adopted after contesting the fact to the MA holder, who can send counter-arguments to AIFA within fifteen days of the contestation itself.
- 20. The marketing authorization holder for medicinal products who violates the obligations set out in article 130 is subject to a payment sanction ranging from thirty thousand to one hundred and eighty thousand euros. The amount of the fine is increased by a variable amount from 0.1 percent to 1 percent of the turnover of the medicinal product for which the violation has been found.
- 21. The marketing authorization holder for medicinal products who violates the obligations set out in article 130 is also obliged, in the event of news of significant interest to patients, to publish, at his own expense, for three consecutive days in the main national newspapers corrections, agreed with AIFA, of previously disclosed information.
- 22. The pharmacovigilance manager of the pharmaceutical company, who violates the obligations of article 131, is subject to the sanction of payment of the sum from twenty thousand euros to one hundred and twenty thousand euros.
- 23. Whoever violates the obligation provided for by article 130, paragraph 12, is subject to the sanction of payment of the sum from ten thousand euros to sixty thousand euros.
- 24. Failure to comply with the provisions envisaged for those in charge of pharmacovigilance in healthcare facilities entails the establishment in the competent offices of proceedings for the disbursement of disciplinary sanctions, according to legislative and contractual provisions.
