• Mon. Oct 25th, 2021

Health: immunotherapeutic allergens, Thm are not AIFA measures

Byeditorial

May 11, 2021

“With a note published on its institutional website consisting of a ‘disclaimer’ containing the following wording ‘The THMs express the opinion of the speakers and represent reflections on the discipline of the sector. They do not constitute provisions of the Italian Medicines Agency’, the Aifa has finally dissolved all doubts about the nature and scope of the so-called Take Home Messages which, since 19 December 2019, the date of publication following the Information Day on Immunotherapy Allergens, had created many doubts within the community of Italian Allergists. therefore the dispute initiated by Hal Allergy BV and Hal Allergy srl, companies among the leaders in the European market of immunotherapeutic allergens, assisted in the dialogue with Aifa by the Professionals of the Meliadò Law Firm, who highlighted how the contents published on the Aifa website, although having an informative character and a clarifying purpose on the complex legislation governing c marketing of Allergen Immunotherapy Products, did not have the scope of Provision of the Regulatory Body, as they were the opinions of the speakers who intervened on the occasion of an ‘Information Day’, thus making it necessary to be clarified by the Body. The clarification arrived on 6.5.2021 (see https://www.aifa.gov.it/documents/20142/1087806/6-2019-12-16_Take_Home_Message_allergeni.pdf) “. note. “Satisfied” all parts of the initiative, continues the note, “representing this clarification by Aifa a fundamental act especially with reference to the Named Patience Products market, ie all those products marketed pursuant to art. 5 of Legislative Decree 219/2006 present in large numbers on the Italian market, which are industrially prepared medicines at the request, written and unsolicited, of the doctor, deemed suitable for this by the regulations in force, who undertakes to use the the aforementioned medicines on a specific patient or the facility in which he / she operates, under his / her direct and personal responsibility; for the purposes of prescription, the provisions envisaged for the magistral preparations of art. 5 of the decree-law of February 17, 1998, n. 23, converted, with modifications, by the law 9 April 1998, n. 94 ‘. The art. 5, of the law n. 23/1998 (so-called Di Bella Law) states that it is the doctor’s responsibility to comply with the provisions contained therein, given that ‘doctors can prescribe magisterial preparations exclusively based on active ingredients described in the pharmacopoeias of the European Union countries or contained in medicines industrially products which are authorized for trade in Italy or in another country of the European Union … ‘”.