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.
With its circular letter dated October 21, 2020, the Ministry of Health clarified that, although surgical masks used by healthcare personnel classify as medical devices, the same are not subject to authorization for health advertising pursuant to Section 21 of Legislative Decree 46/1997, even where the relevant advertising message is addressed to the general public.With its circular letter dated October 21, 2020, the Ministry of Health clarified that, although surgical masks used by healthcare personnel classify as medical devices, the same are not subject to authorization for health advertising pursuant to Section 21 of Legislative Decree 46/1997, even where the relevant advertising message is addressed to the general public.
Italy: Covid-19 – European Commission establishes an authorization mechanism for the export of vaccines
With Regulation (EU) 2021/111, adopted under the urgency procedure and published on January 29, 2021, the European Commission has established that until March 31, 2021, the export of COVID-19 vaccines outside the EU territory is subject to authorization. This authorization regime applies to exports of vaccines by pharmaceutical companies that have signed Advance Purchase Agreements ("APAs") with the EU.
Italy: The disciplinary suspension of union representatives who report noncompliance with COVID-19 health and...
According to a recent ruling from the Italian Supreme Court, trade union representatives cannot be subject to disciplinary sanctions if they demand compliance with COVID-19 health and safety rules at the workplace.
Italy: The AIFA’s clarifications on the procedure for submitting marketing applications for COVID-19 vaccines
In a press release dated December 30, 2020, the AIFA (Agenzia Italiana del Farmaco) clarified that, in view of the current health emergency, applications for placing on the Italian market COVID-19 vaccines are subject to the emergency procedure for Batch Release provided for by the AIFA.
With judgment No. 8126 of 17 December 2020, the Council of State ruled on the legitimacy of an agreement between a public research institution and a private company, entered into without a public call for tenders, whereby the former received COVID-19 serological and molecular tests prototypes to be used in the context of its research activities and undertook to provide the company with the relevant results so that the latter could use them to obtain the CE mark.
On 18 December 2020, the EIOPA (European Insurance and Occupational Pensions Authority) released a communication recommending insurance undertakings to maintain extreme caution in dividend distributions, share buy-backs or variable remunerations. These operations should not exceed thresholds of prudency and institutions should ensure that the resulting reduction in the quantity or quality of their own funds remains at levels appropriate to the current levels of risk.