Orphan medicinal products | Italian Medicines Agency
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Archived: 2026-04-23 17:25
Orphan medicinal products |
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Orphan medicinal products
Orphan medicinal products
Orphan medicines are used for the diagnosis, prevention and treatment of rare diseases. In Europe, a disease is considered rare when it affects no more than 5 people per 10,000 inhabitants.
The first regulation on orphan medicines was introduced in the United States in 1983, with the enactment of the Orphan Drug Act, after which the need to formulate a legislative framework in this area became evident. In 1999 the European Union adopted the EC Regulation 141/2000 and subsequently the EC Regulation 847/2000.
These Regulations set out the criteria and procedure for the designation of orphan medicine, the granting of this status by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency – EMA, the incentives offered and, finally, the approval procedure.
To qualify for orphan designation in the EU a medicine must meet a number of criteria:
1) it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
2) it must be intended for a rare clinical condition and its prevalence in the EU must not be more than 5 in 10,000 inhabitants;
3) no valid alternative treatment should be available, or, if such a alternatives exist, the medicine must be of significant benefit to those affected by the condition.
National legislation
National legislation
The Italian legislation has always protected trials of orphan drugs and their marketing to allow patients’ access to the best therapies available.
With an aim to accelerate the availability of orphan drugs at a local level, the Balduzzi Law (Law 189/2012, Article 12, paragraph 3) established that the pharmaceutical company holding a MA of an orphan drug can apply to AIFA for price and reimbursement as soon as the positive opinion of the CHMP is released, therefore before the granting of the marketing authorization by the European Commission.
The following paragraph 5-bis of the same article provides that AIFA shall evaluate as a priority, for the purposes of classification and reimbursement by the NHS, orphan drugs along with medicines of exceptional therapeutic relevance for which the related application was submitted together with the required documentation.
In this case, the evaluation deadline is reduced to one hundred days (so-called 'fast track authorization'). In case of non-submission within thirty days of the release of the marketing authorization of an orphan drug of exceptional therapeutic importance, AIFA requests the MAH company to submit the application for classification and reimbursement within the following thirty days.
Tools for early access to orphan drugs
In Italy, a patient with a rare disease can access orphan drugs through various legislative instruments. EMA’s centralized authorization procedure, with standard or conditional methods, is the main access rule; alternatively, in the absence of a marketing authorization for an orphan drug indicated for a rare disease, a patient suffering from a rare disease can access the medicine through one of the following procedures provided for by:
Law no. 648/1996, which allows the use of a medicine on a national basis;
Law no. 326/2003, art. 48 (AIFA 5% Fund), Ministerial Decree 8 May 2003 (so-called "Compassionate use");
Law no. 94/1998 (so-called “Di Bella Law”) which, differently from Law 648, governs the prescription of the medicine to the individual patient, on a nominal basis.
Independent research on orphan drugs funded by AIFA
AIFA was the first European regulatory agency to include the promotion of independent scientific research within its institutional objectives, also encouraging the development of orphan drugs through funding of non-profit clinical trials.
The Independent Research promoted by AIFA produces results and knowledge with particular regard to those pathologies which, considering the reduced incidence, often do not arouse commercial interest.
The results of the projects funded by AIFA, in the context of Independent Research, aim to generate evidence with a significant impact on the NHS and on the appropriateness of use of drugs, ensuring adequate repercussions of the scientific results. Independent Research is financed through the 5% Fund (Law no. 326/2003) and is aimed at all Italian researchers from public and non-profit institutions.
Price negotiation of orphan drugs in Italy
Orphan drugs, hospital drugs or drugs of exceptional therapeutic and social importance are evaluated as a priority, with respect to the procedures pending as of the date of the application submission, also through convening extraordinary sessions of the Committees, within the term of 100 days. Moreover, applicable legislation for these drugs provides for an additional facility, namely the right for the company to submit the application for classification and reimbursement prior to the release of their marketing authorization.
Orphan drugs excluded from deficit-lowering procedures
The Budget Law 2019 (Law 31 December 2018, no.145) has modified the methods for lowering the deficit due to pharmaceutical expenditure for direct purchases by the NHS facilities (so-called payback), providing that the distribution of the surplus of expenditure is spread over all the pharmaceutical companies that contribute to the expenditure of direct purchases on the basis of market shares.
It also provided that the orphan drugs that will benefit from the exclusion from the payback procedures will only be those authorized by the EMA, excluding the so-called Orphan Likes, the drugs entered in the Orphanet register and all the drugs that were authorized as Orphans by the EMA but whose period of market exclusivity has expired.
Medicines not included in the so-called EU List of Orphan Drugs (Community Register of designated orphan drugs) will no longer be considered as such in Italy.
AIFA makes available the list of orphan drugs, drafted in compliance with new legislation.
EXPAND ALL
Orphan Medicines List
Orphan medicines lists December 31, 2024 [0.16 Mb] [PDF] >
Orphan medicines lists December 31, 2024 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2024 [0.01 Mb] [CSV] >
Orphan medicines lists December 31, 2023 [0.07 Mb] [PDF] >
Orphan medicines lists December 31, 2023 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2023 [0.01 Mb] [CSV] >
Orphan medicines lists December 31, 2022 [0.44 Mb] [PDF] >
Orphan medicines lists December 31, 2022 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2022 [0.01 Mb] [CSV] >
Orphan medicines lists December 31, 2021 [0.13 Mb] [PDF] >
Orphan medicines lists December 31, 2021 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2021 [0 Mb] [CSV] >
Orphan medicines lists December 31, 2020 [0.14 Mb] [PDF] >
Orphan medicines lists December 31, 2020 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2020 [0 Mb] [CSV] >
Orphan medicines lists December 31, 2019 [0.14 Mb] [PDF] >
Orphan medicines lists December 31, 2019 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2019 [0 Mb] [CSV] >
Orphan medicines lists December 31, 2018 [0.18 Mb] [PDF] >
Orphan medicines lists December 31, 2018 [0.04 Mb] [ODS] >
Orphan medicines lists December 31, 2018 [3.26 Mb] [CSV] >
Site Map
Access to medicinal products
Early access and off-label use
Authorisation of medicinal products
Medicine shortages
Antibiotic medicinal products
Biological medicinal products
Vaccines
Blood derivatives
Generic medicinal products
Biosimilar medicinal products
Orphan medicinal products
Advanced therapies
Homeopathic medicinal products
Allergens
Medicinali di origine vegetale
Ancillary medicinal substances incorporated in medical devices
Share
Related links
Committee Orphan Medical Product (COMP)
Centralised authorization procedure
Nested Applications
Highlights
21/04/2026 - Medicine Use: 2024 Regional Reports Now Available Online
17/04/2026 - From one-size-fits-all treatments to personalised care: the revolution in precision medicine
ALL NEWS
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21/04/2026
Medicine Use: 2024 Regional Reports Now Available Online
15/04/2026
AIFA updates the Transparency Lists
13/04/2026
Medicine Shortage Communication on Endoxan (ciclofosfamide)
All news
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Press
From one-size-fits-all treatments to personalised care: the revolution in precision medicine
All press releases
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Negli ultimi tempi si sta diffondendo un business pericol...
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Italian Medicines Agency
Aifa toggle bar Search
Search keywords
The Agency
The Agency
Mission and values
Organisation
Scientific and Economic Committee for Medicines
Support and Coordination Secretariats and Advisory Committees
International Collaborations
EU Projects
Legislation
Forms
Competition notices
Resolutions
Tenders and contracts
Quality assurance
Guarantee Committee
Atti di notifica
Associazioni dei pazienti
AIFA Incontra
Contacts
Certified email
COVID-19
COVID-19
Communications about COVID-19
COVID-19 Vaccines
Medicines usable for treatment of COVID-19 disease
Use of monoclonal antibodies for COVID-19
Use of antivirals for COVID-19
Monitoring of medicinal products used during the COVID-19 epidemic
Clinical Trials - COVID-19
Compassionate Use Programs - COVID-19
Access to medicinal products
Access to medicinal products
Early access and off-label use
Authorisation of medicinal products
Medicine shortages
Antibiotic medicinal products
Biological medicinal products
Vaccines
Blood derivatives
Generic medicinal products
Biosimilar medicinal products
Orphan medicinal products
Advanced therapies
Homeopathic medicinal products
Allergens
Medicinali di origine vegetale
Ancillary medicinal substances incorporated in medical devices
Safety of medicinal products
Safety of medicinal products
Pharmacovigilance
National Pharmacovigilance Network
Adverse Reactions to medicinal products
Persons in charge of Pharmacovigilance
European Eudravigilance System
Accesso alle segnalazioni - ADRreports
Regional pharmacovigilance funds
Segnali di sicurezza
Risk management measures
Medicinal products subject to additional monitoring
Quality and Inspections
Quality and Inspections
Quality defects
Inspections and authorisations
Qualified person
Fight of pharmaceutical crime
Research and Clinical trials
Research and Clinical trials
Clinical trials concerning medicinal products
EU Regulation on Clinical trials
National Observatory on Clinical Trials
Registro Studi Osservazionali
Comitati Etici Nazionali (CEN)
Ethics Committees Coordination Centre
Independent clinical research
Mappa dei centri di Sperimentazione Clinica
Pricing and reimbursement
Pricing and reimbursement
Negotiation and reimbursement
Economic evaluations
Monitoring Registers
AIFA Notes
Lists of Class A and Class H medicinal products
Innovative medicinal products
Transparency Lists
Consumption and pharmaceutical expenditure
Consumption and pharmaceutical expenditure
The Medicines Utilization Monitoring Centre (OsMed)
Governance of pharmaceutical expenditure
Monitoring pharmaceutical expenditure
Innovation and planning
Innovation and planning
Innovation and scientific advice
Horizon scanning
Information and communication
Information and communication
FarmaciLine
Medical and scientific information
FAQ
Publications
Communication campaigns
Eventi AIFA
Scientific Seminars
Press releases
Dossier AIFA
Mobile APP AIFA
APP Firstline AIFA - Antibiotici
ABC della Ricerca Clinica
Presentations and speeches
Public consultations and documents
Documents shared with scientific communities
Calendario eventi
Archivio
AIFA data
AIFA data
OsMed Data
Open Data
Companies Section
Companies Section
Requests for authorisation of conferences and meetings
Payment of fees and annual duties
MA Electronic invoicing
Application for reimbursement and pricing
Access information
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Opere pubbliche
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Informazioni ambientali
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Altri Contenuti
Orphan medicinal products
Orphan medicinal products
Orphan medicines are used for the diagnosis, prevention and treatment of rare diseases. In Europe, a disease is considered rare when it affects no more than 5 people per 10,000 inhabitants.
The first regulation on orphan medicines was introduced in the United States in 1983, with the enactment of the Orphan Drug Act, after which the need to formulate a legislative framework in this area became evident. In 1999 the European Union adopted the EC Regulation 141/2000 and subsequently the EC Regulation 847/2000.
These Regulations set out the criteria and procedure for the designation of orphan medicine, the granting of this status by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency – EMA, the incentives offered and, finally, the approval procedure.
To qualify for orphan designation in the EU a medicine must meet a number of criteria:
1) it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
2) it must be intended for a rare clinical condition and its prevalence in the EU must not be more than 5 in 10,000 inhabitants;
3) no valid alternative treatment should be available, or, if such a alternatives exist, the medicine must be of significant benefit to those affected by the condition.
National legislation
National legislation
The Italian legislation has always protected trials of orphan drugs and their marketing to allow patients’ access to the best therapies available.
With an aim to accelerate the availability of orphan drugs at a local level, the Balduzzi Law (Law 189/2012, Article 12, paragraph 3) established that the pharmaceutical company holding a MA of an orphan drug can apply to AIFA for price and reimbursement as soon as the positive opinion of the CHMP is released, therefore before the granting of the marketing authorization by the European Commission.
The following paragraph 5-bis of the same article provides that AIFA shall evaluate as a priority, for the purposes of classification and reimbursement by the NHS, orphan drugs along with medicines of exceptional therapeutic relevance for which the related application was submitted together with the required documentation.
In this case, the evaluation deadline is reduced to one hundred days (so-called 'fast track authorization'). In case of non-submission within thirty days of the release of the marketing authorization of an orphan drug of exceptional therapeutic importance, AIFA requests the MAH company to submit the application for classification and reimbursement within the following thirty days.
Tools for early access to orphan drugs
In Italy, a patient with a rare disease can access orphan drugs through various legislative instruments. EMA’s centralized authorization procedure, with standard or conditional methods, is the main access rule; alternatively, in the absence of a marketing authorization for an orphan drug indicated for a rare disease, a patient suffering from a rare disease can access the medicine through one of the following procedures provided for by:
Law no. 648/1996, which allows the use of a medicine on a national basis;
Law no. 326/2003, art. 48 (AIFA 5% Fund), Ministerial Decree 8 May 2003 (so-called "Compassionate use");
Law no. 94/1998 (so-called “Di Bella Law”) which, differently from Law 648, governs the prescription of the medicine to the individual patient, on a nominal basis.
Independent research on orphan drugs funded by AIFA
AIFA was the first European regulatory agency to include the promotion of independent scientific research within its institutional objectives, also encouraging the development of orphan drugs through funding of non-profit clinical trials.
The Independent Research promoted by AIFA produces results and knowledge with particular regard to those pathologies which, considering the reduced incidence, often do not arouse commercial interest.
The results of the projects funded by AIFA, in the context of Independent Research, aim to generate evidence with a significant impact on the NHS and on the appropriateness of use of drugs, ensuring adequate repercussions of the scientific results. Independent Research is financed through the 5% Fund (Law no. 326/2003) and is aimed at all Italian researchers from public and non-profit institutions.
Price negotiation of orphan drugs in Italy
Orphan drugs, hospital drugs or drugs of exceptional therapeutic and social importance are evaluated as a priority, with respect to the procedures pending as of the date of the application submission, also through convening extraordinary sessions of the Committees, within the term of 100 days. Moreover, applicable legislation for these drugs provides for an additional facility, namely the right for the company to submit the application for classification and reimbursement prior to the release of their marketing authorization.
Orphan drugs excluded from deficit-lowering procedures
The Budget Law 2019 (Law 31 December 2018, no.145) has modified the methods for lowering the deficit due to pharmaceutical expenditure for direct purchases by the NHS facilities (so-called payback), providing that the distribution of the surplus of expenditure is spread over all the pharmaceutical companies that contribute to the expenditure of direct purchases on the basis of market shares.
It also provided that the orphan drugs that will benefit from the exclusion from the payback procedures will only be those authorized by the EMA, excluding the so-called Orphan Likes, the drugs entered in the Orphanet register and all the drugs that were authorized as Orphans by the EMA but whose period of market exclusivity has expired.
Medicines not included in the so-called EU List of Orphan Drugs (Community Register of designated orphan drugs) will no longer be considered as such in Italy.
AIFA makes available the list of orphan drugs, drafted in compliance with new legislation.
EXPAND ALL
Orphan Medicines List
Orphan medicines lists December 31, 2024 [0.16 Mb] [PDF] >
Orphan medicines lists December 31, 2024 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2024 [0.01 Mb] [CSV] >
Orphan medicines lists December 31, 2023 [0.07 Mb] [PDF] >
Orphan medicines lists December 31, 2023 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2023 [0.01 Mb] [CSV] >
Orphan medicines lists December 31, 2022 [0.44 Mb] [PDF] >
Orphan medicines lists December 31, 2022 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2022 [0.01 Mb] [CSV] >
Orphan medicines lists December 31, 2021 [0.13 Mb] [PDF] >
Orphan medicines lists December 31, 2021 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2021 [0 Mb] [CSV] >
Orphan medicines lists December 31, 2020 [0.14 Mb] [PDF] >
Orphan medicines lists December 31, 2020 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2020 [0 Mb] [CSV] >
Orphan medicines lists December 31, 2019 [0.14 Mb] [PDF] >
Orphan medicines lists December 31, 2019 [0.01 Mb] [ODS] >
Orphan medicines lists December 31, 2019 [0 Mb] [CSV] >
Orphan medicines lists December 31, 2018 [0.18 Mb] [PDF] >
Orphan medicines lists December 31, 2018 [0.04 Mb] [ODS] >
Orphan medicines lists December 31, 2018 [3.26 Mb] [CSV] >
Site Map
Access to medicinal products
Early access and off-label use
Authorisation of medicinal products
Medicine shortages
Antibiotic medicinal products
Biological medicinal products
Vaccines
Blood derivatives
Generic medicinal products
Biosimilar medicinal products
Orphan medicinal products
Advanced therapies
Homeopathic medicinal products
Allergens
Medicinali di origine vegetale
Ancillary medicinal substances incorporated in medical devices
Share
Related links
Committee Orphan Medical Product (COMP)
Centralised authorization procedure
Nested Applications
Highlights
21/04/2026 - Medicine Use: 2024 Regional Reports Now Available Online
17/04/2026 - From one-size-fits-all treatments to personalised care: the revolution in precision medicine
ALL NEWS
ALL NEWS
News
21/04/2026
Medicine Use: 2024 Regional Reports Now Available Online
15/04/2026
AIFA updates the Transparency Lists
13/04/2026
Medicine Shortage Communication on Endoxan (ciclofosfamide)
All news
Nested Applications
Press
From one-size-fits-all treatments to personalised care: the revolution in precision medicine
All press releases
Last tweets
📢 #AIFA comunica il calendario degli incontri nell’ambito delle iniziative dedicate al dialogo e al...
Vai al post →
🔬 AIFA pubblica il dossier “Dalle terapie a taglia unica alle cure su misura: la rivoluzione della ...
Vai al post →
🎙️ “Immagino un futuro in cui ciascuno di noi abbia un vero e proprio passaporto farmacogenetico, m...
Vai al post →
💊 Quasi 4 cittadini su 10 hanno ricevuto almeno una prescrizione di #antibiotici nel 2024, con una ...
Vai al post →
⚠️ Attenzione alle false cure miracolose
Negli ultimi tempi si sta diffondendo un business pericol...
Vai al post →
#AIFA promuove l’ascolto e la trasparenza
Approvati i Regolamenti di “AIFA Ascolta” e “AIFA Incontr...
Vai al post →
Go to Twitter profile
Go to Twitter profile
aifa_ufficiale
Multimedia
Medicina di precisione e appropriatezza prescrittiva
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Contacts
Via del Tritone, 181 00187 Roma
Contacts
Certified e-mail (PEC) contacts
VAT number: 08703841000
Tax code: 97345810580
IPA AIFA code: aifa_rm
IPA UCB code: UFE1TR
FOLLOW US ON
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Bluesky
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