In the context of their surveillance activity against pharmaceutical cybercrimes, the Italian Anti-Adulteration Units (NAS) ordered the shutdown of four websites that unlawfully performed the online sale of drugs and vaccines with alleged therapeutic properties for the treatment of COVID-19.
On 25 February 2021, the EMA’s (European Medicine Agency) committee for Medicinal Products for Human Use (CHMP) published new guidelines for manufacturers of COVID-19 vaccines that intend to adapt them to SARS-CoV-2 virus variants.
The Italian Government has blocked the export of 250,700 doses of COVID-19 vaccine to Australia. This decision represents…
COVID-19 restrictions to international travel that have been enacted since the beginning of the pandemic require individuals traveling to Italy from some foreign countries to observe a 14-day mandatory quarantine.
On March 2, 2021 the Italian government enacted a new decree, in relation to COVID-19 measures. These provisions come into force on March 6, 2021 and will apply until April 6, 2021.
In brief On March 2, 2021 the Italian government enacted a new decree, in relation to COVID-19 measures.…
With a judgement dated 17 December 2020 (case C-667/19), the EU Court of Justice (CJEU) provided clarifications on the principles governing the manner in which certain mandatory indications must be shown on the labelling of cosmetic products.
The European Medicines Agency (EMA) and the National Competent Authorities of the EU Member States (NCAs) have adopted the COVID-19 vaccine safety monitoring plan setting forth the methods for collecting and reviewing data obtained as a result of the marketing and administration of the new vaccines.
With a communication dated 11 January 2021, the European Commission has recognized the possibility for Notified Bodies to perform remote audits on medical devices aimed at verifying compliance with applicable safety and effectiveness and obtaining the CE marking.
In a statement dated 4 February 2021, the EMA announced that the Committee for Medicinal Products for Human Use (CHMP) is reviewing available data on the use of monoclonal antibodies casirivimab, imdevimab, bamlanivimab and etesevimab to treat COVID-19 patients who do not require oxygen supplementation. Recent studies have shown that the antibodies may have a greater effect when used in combination (casirivimab with imdevimab and bamlanivimab with etesevimab), which is the reason why two separated reviews are being conducted.