Aifa.gov.it

Italian Medicines Agency

WEBInnovative medicines list: AIFA publishes March 2024 update. AIFA updates the list of medicines that, in the opinion of the Scientific and Technical Committee (CTS), meet the …

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URL: https://www.aifa.gov.it/en/web/guest/home

Lists of Class A and Class H medicinal products

WEBThey contain the list of Class A and Class H medicinal products, dispensed by the National Health Service, sorted by active substance and by trade name. They allow physicians to …

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Access to medicinal products Italian Medicines Agency

WEBProtecting citizens’ health through access to safe, effective and quality medicines is one of AIFA’s priority objectives. For this reason, the Agency is committed to guaranteeing the …

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Inspections and authorisations Italian Medicines Agency

WEBAIFA guarantees Good Clinical Practice (GCP) inspections on clinical trials concerning medicinal products, the inspections’ follow up, and the implementation of GCP rules and …

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Quality and Inspections Italian Medicines Agency

WEBQuality and Inspections. AIFA supervises and monitors the manufacturing sites of pharmaceutical companies, in order to ensure quality in the manufacturing of …

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Safety of medicinal products Italian Medicines Agency

WEBAIFA monitors the safe use of medicinal products to ensure the benefit/risk profile of each medicine is positive. Such activity is carried out through the continuous …

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notizia Italian Medicines Agency

WEBPress release n° 680 - The Italian Medicine Agency (AIFA) announces that on 22 December 2021, the Scientific-Technical Committee (CTS) authorized two …

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Application for reimbursement and pricing Italian Medicines …

WEBGuidelines and procedures for submitting to AIFA applications for reimbursement and pricing by pharmaceutical companies are available on this page, in accordance with the …

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The Agency Italian Medicines Agency

WEBThe Italian Medicines Agency - AIFA is a public body operating according to the principles of autonomy, transparency and efficiency, under the direction of the Ministry of Health …

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Requests for authorisation of conferences and meetings

WEBAny Italian or foreign pharmaceutical company which is the owner of medicines with marketing authorisation in Italy (AIC), or which on the basis of an agreement with the …

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Vaccines Italian Medicines Agency

WEBDepending on the type of active component, the vaccines are divided into: live attenuated vaccines, produced from non-pathogenic micro-organisms (for example, those …

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Payment of fees and annual duties Italian Medicines Agency

WEBIn order benefit from the reductions established introduced by article 4, paragraph 6, of Health Ministry decree no. 53 dated 29 March 2012, by paragraph 3 of resolution no. 21 …

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GMP inspections and authorisations

WEBIn case of general review inspections, extension inspections, follow-up inspections, activation inspections, in order to allow the inspectors a preliminary and overall …

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Authorisation of medicinal products Italian Medicines Agency

WEBAuthorisation of medicinal products. In order to be marketed in Italy, a medicinal product must be granted a Marketing Authorisation (MA) by AIFA or the European Commission. …

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Organisation Italian Medicines Agency

WEBThe bodies of the Agency are the President, the Board of Directors, and the Board of Auditors. President. The President is the legal representative of the Agency and is …

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Economic evaluations Italian Medicines Agency

WEBEconomic evaluations. Economic evaluations are a tool for defining the value of a medicinal product in terms of cost-opportunity, from the point of view of the patient, the NHS and …

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COVID-19 Vaccines Italian Medicines Agency

WEB03/11/2022. Thirteenth AIFA Report on the surveillance of anti-COVID-19 vaccines. 20/10/2022. EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines …

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AIFA data Italian Medicines Agency

WEBAIFA data. AIFA promotes enhancement, accessibility and transparency of its information assets through releasing data, favouring their use and reuse, in compliance with current …

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