12
Apr 21
The Italian Medicines Agency provides additional information on the new simplified classification procedure for generics and biosimilars
The Italian Drug Agency (AIFA) provided further information on the new simplified pricing and reimbursement procedure introduced in October 2020 for generics and biosimilars.
12
Apr 21
COVID-19: Transparency mechanism in the export of COVID-19 vaccines outside EU
Due to persistent delays in deliveries of vaccines to the EU, on March 11, 2021 the European Commission adopted the new Implementing Regulation (EU) 2021/442, renewing, with amendments, through the end of June, the transparency and authorization mechanism for COVID-19 vaccine exports.
9
Apr 21
The “Pharmacy of Services” becomes more and more real
In recent months, under the pressure of the Covid-19 emergency, pharmacies have become more and more involved in the delivery of healthcare services to patients, in support of formal healthcare facilities and operating under the umbrella of the NHS.
9
Apr 21
Parallel import of medicines: New simplified AIFA procedure for negotiating price and reimbursement
On March 25, 2020, the Italian Agency of Medicines (AIFA) published a resolution on the simplified procedure for negotiating the price and reimbursement of parallel imported medicines.
1
Mar 21
E-prescriptions now available also for drugs not reimbursed by the NHS
On December 30, 2020, the Ministry of Economy and Finance adopted a decree (“Ministerial Decree”) that provided the possibility for doctors to issue e-prescriptions for drugs not reimbursed by the National Health Service (“NHS”).
26
Feb 21
<!--:it-->Foreign investment control regulations: extension of COVID-19–related rules and new list and definition of strategic assets with a brief focus on the health industry<!--:-->
At the end of 2020, important regulatory measures regarding Italian foreign investment control regulations (known as the Golden Powers) were enacted: (i) a revised list and definition of critical and strategic assets in sectors relevant for the purposes of these regulations entered into force with effect from January 14, 2021, and (ii) the COVID-19 emergency rules providing for a temporary broadening of the scope of notification duties (which, among other things, also involve intra-EU transactions) have been extended through June 30, 2021.
