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9AprMedical Devices Regulation: EU Commission proposes a one year postponement of the application dateThe European Commission adopted a proposal to postpone the date of application of Medical Device Regulation by one year and deviate from the conformity assessment procedures in cases of emergency.Articolo inserito in: Life Sciences-Healthcare
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9AprAIFA: latest indications for "remote" clinical trials during the COVID-19 health emergencyOn April 7, 2020, the Italian Medicines Agency (“AIFA”) provided guidance on the management of clinical trials in light of the restrictive measures adopted by the Government against the COVID-19 pandemic.
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8AprCOVID-19 emergency: clinical trials and early access to drugsTo address the current emergency caused by COVID-19, several initiatives have been undertaken at the regulatory level to promote and facilitate clinical trials and early access to drugs.
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8AprEmergenza Covid-19, ricette mediche sempre più dematerializzate: i prossimi stepL’Ordinanza del 19 marzo per limitare gli spostamenti delle persone, ha aumentato l’uso della ricetta elettronica, introducendo importanti novità nella comunicazione del promemoria. Facciamo il punto sul quadro normativo alla luce del DM del 25 marzo, che ha confermato alcune delle novità e ne ha introdotto altre
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31MarL’Agenzia delle Dogane e dei Monopoli ha indicato le istruzioni da seguire per la procedura di svincolo diretto di beni mobili necessari a contrastare COVID-19Il Commissario Straordinario dell’Agenzia delle Dogane e dei Monopoli ha stabilito una procedura di svincolo diretto e celere per i dispositivi di protezione individuale e altri beni necessari per contrastare il Covid-19.Articolo inserito in: COVID-19
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31MarCOVID-19 and consumer protection: the impact on selling and advertising practices and early reactions from relevant Italian bodiesHow coronavirus impacted sales and advertising from a practical standpoint
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30MarMain Takeaways on the Italian COVID-19 Emergency Legislation and the Media IndustryThe measures adopted by the Italian Government and the Italian Communications Authority vis-à-vis the media industry in the realm of the COVID-19 pandemic.
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26MarEuropean Commission moves to ensure supply of personal protective equipment in the European UnionIn response to the COVID-19 emergency, the Commission adopted an Implementing Regulation foreseeing that exports of personal protective equipment outside of the EU shall be subject to authorization.Articolo inserito in: COVID-19
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23MarCOVID-19 and IP rights: production of life-saving respiratory valves using 3D printersThe Covid-19 health emergency poses new challenges to legal rule. A hospital’s recent production of respiratory valves using a 3D printer has prompted reflection on intellectual property rights.
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23Mar
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