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Agenzia Italiana del Farmaco
Ricerca AIFA
List of titles
Notice of forthcoming discontinuation of use of allergen immunotherapy products for the purposes of therapeutic continuity Highlights News
Given the time elapsed since the adoption of the mentioned measures, holders of allergen products for immunotherapy who were the subject of the rejection decision, are hereby informed that AIFA will issue a specific provision regarding the end of the therapeutic continuity within six months from the date of publication of this notice on the AIFA’s institutional website.
Thu Mar 21 00:00:00 CET 2024 Access to medicinal productsUpdating of Annex 1 - list of allergenes admitted to the registration procedure Highlights News
Notice of updating of Annex 1: Allergenic products admitted to the registration procedure pursuant to DG Resolution no. 2130/2017 of 22 December 2017
Wed Mar 13 00:00:00 CET 2024 Access to medicinal productsUpdate of Annex 1 of Director-General Decision DG 442/2023 Highlights News
AIFA has published its Director-General Decision DG 34/2024 of 8 February 2024 (GU Serie Generale n. 45 23-02-2024) which updates the Annex 1 of AIFA’s Director-General Decision DG 442/2023
Tue Feb 27 00:00:00 CET 2024 Access to medicinal productsRenewal of the provisional authorisation to use haptens for patch tests in the absence of commercially-available clinical alternatives Highlights News
AIFA has published its Director-General Decision DG 442/2023 of 13 November 2023 (GU Serie Generale n.268, 16-11-2023) which renews the authorization to use haptens for patch tests that have not yet been authorized with an MA or that are not authorized for sale ope legis, on an exceptional basis and in the absence of clinical alternatives.
Mon Nov 27 00:00:00 CET 2023 Access to medicinal productsNotice on commercial availability of haptens for patch tests Highlights News
Comunication on the reports received regarding the unavailability on the market of some haptens of the Adults and Pediatric Baseline Patch Test Series and Cosmetic Additional Patch Test Series, drafted by the AIFA Working Group on the clinical use of haptens for patch test and published on the Agency's web site.
Tue Apr 04 00:00:00 CEST 2023 Access to medicinal productsUpdated lists of allergens for specific immunotherapy and diagnosis published following the end of the transitional phase initiated with AIFA Decision DG 2130/2017 Highlights News
Following the withdrawal of some registration procedures on a voluntary basis by the companies concerned, the lists already published following the conclusion of the transitional phase started with AIFA Decision DG 2130/2017 were updated on 2st February 2023.
Thu Feb 02 00:00:00 CET 2023 Access to medicinal productsAnnex of AIFA’s Director-General Decision DG 98/2022 of 24 February 2022 Highlights News
Notice of updating of the annex of AIFA’s Director-General Decision DG 98/2022 of 24 February 2022.
Mon Jan 23 00:00:00 CET 2023 Access to medicinal productsRegulation and clinical use of haptens for patch testing Highlights News
The Italian Medicines Agency publishes the first document on Regulation and clinical use of haptens for patch testing.
Mon Jan 23 00:00:00 CET 2023 Access to medicinal productsUpdate on AIFA haptens for patch test regulation process
Ope legis allergens are products marketed without any marketing authorization (MA) in compliance with Ministerial Decree of 13 December 1991, that allowed products already used in Italy before 1 October 1991 to remain on the market until they were granted a regular MA. The assessment of the ope legis allergen dossier is ongoing in order to grant a marketing authorization.
Fri Oct 07 00:00:00 CEST 2022 Access to medicinal productsUpdating of the annex of AIFA’s Director-General Decision DG 98/2022
Notice of updating of the annex of AIFA’s Director-General Decision DG 98/2022 of 24 February 2022.
Tue Apr 05 00:00:00 CEST 2022 Access to medicinal productsInstitution of the AIFA Technical Table on the clinical use of haptens for patch tests Highlights News
Following the overall evaluation of the candidacies proposed by the Scientific Societies in the allergen field requested by the Agency with a call on 10/12/2021, we inform you that the AIFA Technical Table on the clinical use of haptens for patch tests has been set up by decision of the Director General DG 134/2022 of 03/30/2022.
Thu Mar 31 00:00:00 CEST 2022 Access to medicinal productsUpdating of the list of haptens of AIFA’s Director-General Decision DG 1334/2021 Highlights News
AIFA has published its Director-General Decision DG 98/2022 of 24 February 2021.
Thu Mar 03 00:00:00 CET 2022 Access to medicinal productsUpdated lists of allergens for specific immunotherapy and diagnosis published following the end of the transitional phase initiated with AIFA Decision DG 2130/2017 Highlights News
The Agency, the lists already published following the end of the transitional phase initiated with AIFA Decision DG 2130/2017 were updated on 10 December 2021.
Mon Dec 13 00:00:00 CET 2021 Access to medicinal productsCall for applications from Scientific Societies to take part in the AIFA Technical Group on allergens for patch tests Highlights News
In order to establish an AIFA Technical Group with the aim of drawing up a national guidance document on the clinical use of haptens for patch tests, Scientific Societies in this field are invited to submit three applications accompanied by a CV and a public declaration of interest and commitment to confidentiality (annexed forms) within 10 days of this announcement.
Thu Dec 09 00:00:00 CET 2021 Access to medicinal products > Authorisation of medicinal productsDetermina DG 1334/2021 - Autorizzazione in via transitoria all’uso di apteni per patch test in assenza di alternative cliniche in commercio
Determina DG 1334/2021 del 10 novembre 2021 concernente "Autorizzazione in via transitoria all’uso di apteni per patch test in assenza di alternative cliniche in commercio"
Wed Nov 17 00:00:00 CET 2021 The Agency > ResolutionsPublic consultation of list of haptens currently used Highlights News
Following meetings with pharmaceutical companies and the scientific society SIDeMaST, concerning the absence of haptens authorised by law or with a marketing authorisation number, in order to overcome the issues raised and make these substances available, AIFA publishes the list of haptens that are currently used. This list will be used for the temporary approval of such haptens pending their regulation.
Fri Oct 15 00:00:00 CEST 2021 Access to medicinal productsMedicinali allergeni. Comunicazione su smaltimento scorte e lotti per continuità terapeutica Highlights News
Nell’ambito del processo di regolamentazione dei medicinali allergeni avviato da AIFA con la Determina DG n. 2130/2017, è stata conclusa la prima fase di verifica dell’ammissibilità dei prodotti al processo di registrazione per il rilascio dell’autorizzazione all’immissione in commercio (AIC), con relativa comunicazione dell’esito alle aziende coinvolte.
Tue Jan 21 00:00:00 CET 2020 Access to medicinal productsConclusione del procedimento avviato con Determina AIFA DG n° 2130/2017 Highlights News
Con Determina DG n. 2130/2017, l’AIFA ha inteso riavviare il processo di regolamentazione per la conclusione della fase transitoria per il rilascio dell’Autorizzazione all’Immissione in Commercio (AIC) dei medicinali allergeni afferenti al D.M. 13.12.1991, con la conseguente definizione degli adempimenti posti a carico delle aziende interessate.
Thu Dec 12 00:00:00 CET 2019 Access to medicinal productsGiornata informativa sugli allergeni - 16 dicembre Highlights News
Si svolgerà il 16 dicembre la Giornata informativa sugli allergeni, organizzata dall'AIFA al fine di illustrare lo stato dell’arte alla luce del processo avviato con la Determina AIFA 2130 del 2017. L'evento, che si terrà presso la sede dell'Agenzia in Via del Tritone 181, rappresenterà l'occasione per offrire una panoramica generale sui medicinali allergeni in commercio in Italia e approfondire, tra gli altri, l'ambito normativo.
Tue Dec 10 00:00:00 CET 2019 Access to medicinal productsMedicinali allergeni: aggiornamenti AIFA sul processo di registrazione Highlights News
L’AIFA ha appena concluso la prima fase del processo di regolamentazione dei medicinali allergeni avviato con la determina DG n. 2130/2017 del 22 dicembre 2017, che fissava tempistiche e modalità con cui le aziende avrebbero dovuto presentare la documentazione all’Agenzia, al fine di concludere la fase transitoria per il rilascio dell’ autorizzazione all’immissione in commercio (AIC). Attualmente, infatti, la maggior parte dei medicinali allergeni, ad eccezione di poche immunoterapie specifiche ...
Tue Nov 19 00:00:00 CET 2019 Access to medicinal productsConsultazione pubblica linee guida medicinali allergeni
Il Gruppo di coordinamento per le procedure di mutuo riconoscimento e decentrate (CMD-h) ha avviato una consultazione pubblica su una nuova linea guida sui medicinali allergeni. Le parti interessate a partecipare alla consultazione pubblica possono inviare i propri commenti secondo le modalità e nelle tempistiche riportate sul sito HMA Public consultation.
Wed Jul 03 00:00:00 CEST 2019 Access to medicinal productsAutorizzazione all’Immissione in Commercio dei medicinali allergeni afferenti al D.M. 13.12.1991
È stata pubblicata in Gazzetta Ufficiale la Determina del Direttore Generale n° DG/2130/2017 del 22 dicembre 2017 relativa alla conclusione della fase transitoria per il rilascio dell'Autorizzazione all’Immissione in Commercio dei medicinali allergeni afferenti al D.M. 13.12.1991 e alla definizione degli adempimenti a carico delle aziende interessate. La Determina tratta esclusivamente i medicinali allergeni già utilizzati in Italia anteriormente al 01.10.1991 per i quali le aziende avevano pres...
Mon Jan 15 00:00:00 CET 2018 Access to medicinal products