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.
The Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA) replicates the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) on a bilateral basis. The Canada-UK TCA (signed December 2020) came into force from 1 January 2021 and aims to maintain the status quo in the trade relationship.
Following four and a half years of often acrimonious negotiations and numerous build ups to a no-deal situation, the EU-UK TCA represents a positive step. While the deal is relatively thin and offers only discrete regulatory reciprocity, overall the TCA is a welcome development in the face of apparent near- political failure to agree on a way forward between the two sides. The life sciences sector has been preparing for no-deal amidst the global coronavirus (COVID-19) pandemic, throughout 2020, and having a deal, however slim, is positive for the sector in providing more fertile political ground for future harmonisation and cooperation
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.
Australia: New AER enforcement powers and significantly increased penalties for National Energy Law breaches
The Statutes Amendment (National Energy Laws) (Penalties and Enforcement) Act 2020 (Act) commenced on 29 January 2021, arming the Australian Energy Regulator (AER) for the first time with the power to compulsorily seek information and to undertake compulsory examinations in the course of investigations. The Act also very significantly increases the maximum penalties for contraventions of the civil penalty provisions in the National Energy Law and associated legislation and rules, on terms that are analogous to the penalty regime in the Australian Consumer Law.This alert summarises the key changes and risks associated with the new regime that market participants should be aware of, and identifies steps that should now be taken to minimise those risks.
On December 10, 2020, the Federal Ministry of Justice and Consumer Protection (BMJV) published a ministerial draft bill on the implementation of the directive on the sale of goods (Directive (EU) 2019/771) ("Sales of Goods Directive"). The Sales of Goods Directive supersedes and succeeds the directive on the sale of consumer goods (Directive 1999/44/EC), which has been implemented into the German Civil Code (Bürgerliches Gesetzbuch; "BGB") since January 1, 2002.