AIFA
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News
AIFA. The 5% fund is under management: it is intended for the use of orphan drugs for the treatment of rare diseases
New online service for the management of the AIFA 5% Fund From 1 July 2022, access to the AIFA 5% National Fund…
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Critical drugs in Europe. EMA activates i-SPOC, single point of contact for the sector which will inform EMA
I titolari dell’autorizzazione all’immissione in commercio (AIC) possono ora registrare il loro , (i-SPOC) della fornitura e della disponibilità…
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The purchase of drugs in the Cnn class: critical issues and addresses at a legal level
In 2012, with the law n. 189, also known as the Balduzzi Decree, the legislator intended to provide a new instrument…
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AIFA. Launch of the "TrovaNormeFarmaco" portal
L’Agenzia Italiana del Farmaco ha attivato il portale TrovaNormeFarmaco con l’obiettivo di favorire la ricerca e la consultazione della normativa…
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First floor
Prof. Garattini: "True independent information on medicines is urgently needed". Ed
On Thursday 16 June, L'Avvenire published an Appeal by Prof. Silvio Garattini entitled "True independent information on…
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New reports of adverse reactions to drugs and vaccines
With the launch of the new National Pharmacovigilance Network (RNF), the new forms will come into force on 20 June 2022…
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EMA publishes list of critical Covid-19 medicines
Il 7 giugno 2022, il Medicines Shortages Steering Group (MSSG) dell’EMA ha adottato l’elenco dei farmaci critici per l’emergenza sanitaria…
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Labeling and package leaflet of veterinary drugs: postponement of the new European standards to 2027
La nuova normativa europea sui farmaci veterinari, entrata in vigore il 28 Gennaio 2022, non potrà essere rispettata per quanto…
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Launch of the new National Pharmacovigilance Network
On June 20, 2022, the new National Pharmacovigilance Network (RNF) and a new international standard format will come into operation…
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Antitrust. Fine of around 3.5 million euros to the Leadiant group (formerly Sigma-Tau Pharmaceuticals) for abuse of dominant position
According to the Authority, since June 2017 it has imposed unjustifiably heavy prices on the NHS for the sale of a life-saving drug. Analogs…
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