Italian Medicines Agency and medicines shortage: published Q&A for MAHs on notification of shortage and any temporary or permanent interruption in the marketing of medicines
11
Jun 20
Masks, disinfectants, and serological tests: regulatory issues relating to products to be used in phases 2 and 3 of the emergency period
After the lockdown, for correct management of phases 2 and 3, products such as masks and disinfectants become even more essential in containing and preventing the spread of COVID-19.
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.
Medical Devices Regulation: European Commission adopted a proposal to postpone the date of application of the MDR by one year, until 26 May 2021
