29
May 20
COVID-19 emergency and processing of health data for scientific research purposes
The health emergency due to the spread of COVID-19 has made the need to correctly manage the processing of health data for scientific research purposes even more topical.
Medical Devices Regulation: Regulation 2020/561 has been published in the Official Journal of the European Union postponing the date of application of MDR by one year to 26 May 2021
9
Apr 20
Medical Devices Regulation: EU Commission proposes a one year postponement of the application date
On 3 April 2020, to prioritize the fight against the Covid-19 pandemic crisis, the European Commission adopted a proposal to (i) postpone the date of application of Regulation (EU) 2017/745 on medical devices (“MD Regulation”) (scheduled for 26 May 2020) by one year and (ii) deviate from the normal conformity assessment procedures of medical devices in cases of need and emergency.
9
Apr 20
COVID-19 emergency: increasingly dematerialized prescriptions
In order to reduce the spread of Covid-19, on March 19 the Head of the Civil Protection Department adopted an ordinance (“Ocdpc 651/2020” or “Ordinance“) allowing a citizen to receive from his/her physician an electronic prescription number (numero di ricetta elettronica – “NRE“), which is necessary to get a prescription drug from a pharmacy, without going to the doctor’s office.
9
Apr 20
AIFA: latest indications for "remote" clinical trials during the COVID-19 health emergency
On 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.
8
Apr 20
COVID-19 emergency: clinical trials and early access to drugs
To 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.
