Aifa.gov.it

Italian Medicines Agency

WEBList of class A and H medicinal products at 15 November 2023. AIFA makes available, to healthcare professionals, a list of class A and H medicinal products …

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

COVID-19 Vaccines Italian Medicines Agency

WEBDirect communication with healthcare professionals on Spikevax bivalent booster vaccines. 03/11/2022. Thirteenth AIFA Report on the surveillance of anti-COVID-19 vaccines. …

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Vaccines Italian Medicines Agency

WEBVaccines are biological medicines aimed at preventing one or more infectious diseases by stimulating the immune system (production of antibodies, activation of specific cells) and …

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The Agency Italian Medicines Agency

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

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notizia Italian Medicines Agency

WEBMolnupiravir is an oral antiviral (authorized for distribution in emergency conditions with the Decree of the Ministry of Health of 26 November 2021), indicated …

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Lists of Class A and Class H medicinal products

WEBThe lists of Class A medicinal products include both medicines present in the AIFA Transparency Lists and patent-covered medicinal products as well as medicinal …

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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 …

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Clinical trials concerning medicinal products Italian Medicines …

WEBClinical research in Italy involves many actors: AIFA, for study authorisation and amendments to each phase; the Istituto Superiore di Sanità for consultative opinions on …

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Horizon scanning Italian Medicines Agency

WEBHorizon Scanning. Horizon Scanning is generally defined as the systematic identification of new, emerging or outdated health technologies that have a potential impact on health, …

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Negotiation and reimbursement Italian Medicines Agency

WEBNegotiation and reimbursement. AIFA and its technical and advisory committees are responsible for defining the system of eligibility for reimbursement and supply for all …

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2021 National Report on Medicines Use in Italy

WEBAIFA has published the 2021 National Report on Medicines Use in Italy, prepared by AIFAs Medicines Utilisation Monitoring Centre (OsMed) Now in its twenty-second edition, the …

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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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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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Adverse Reactions to medicinal products Italian Medicines Agency

WEBThe reports of suspected adverse reactions (Adverse Drug Reactions, ADRs) to drugs and vaccines allow the detection of potential alert signals relating to the use of medicines, to …

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Economic evaluations Italian Medicines Agency

WEBThe World Health Organization defines "pharmacoeconomic analysis" as the set of analysis methodologies aimed at identifying, measuring and evaluating the costs and related …

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notizia Italian Medicines Agency

WEBOn the occasion of the World AMR Awareness Week called by the World Health Organisation (18-24 November 2023), the Italian Medicines Agency is promoting, …

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notizia Italian Medicines Agency

WEBAIFA approved the document containing the provisions required by art. 2 of Ministerial Decree of 2 August 2019, Criteria and procedures according to which the …

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Quality defects Italian Medicines Agency

WEBA further health protection measure is seizure, which can be ordered by AIFA or by the NAS, and provides for a number of options, such as sealing up the packages and …

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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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Ethics Committees Coordination Centre Italian Medicines Agency

WEBThe National Coordination Centre of Local Ethics Committees for clinical trials on medicinal products for human use and medical devices, provided for by Art. 2 of Law 11 January …

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GMP inspections and authorisations

WEBSuch periodic inspections, in addition to protecting public health, provide companies with the opportunity to obtain a GMP certificate, to be used for registration or marketing …

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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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