As of May 26, 2022, new rules embedded in Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) have entered into force. The new rules aim to : • improve the quality, safety, and reliability of IVDR devices through a risk-based classification system• strengthen transparency and information for patients, so that pertinent information is more […]
The 2019/2020 European Union Summary Report on Antimicrobial Resistance in zoonotic and indicator bacteria from humans, animals, and food was officially published on 29 March 2022. The report was conducted by the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA). The report details antimicrobial resistance by each individual […]
The EU has brought a WTO action against the UK government on the basis of the WTO Agreement on subsidiaries and countervailing measures (“SCM Agreement”). The EU claims that the UK has granted an unjustified State aid to UK-based beneficiaries to use UK-made wind turbines, thus breaching the principle of non-discriminatory treatment included in the […]
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on corporate sustainability due diligence and amending Directive (EU) 2019/1937 – 2022/0051 (COD) On 23 February 2022, the European Commission published a proposal for a directive on corporate sustainability due diligence. This proposal for a directive aims to introduce a duty of care […]
Judgment of the Court of Justice of the EU of 24 March 2022, Somogy Megyei Kormányhivatal v Upfield Hungary Kft. Upfield Hungary Kft, case C-533/20 In a judgment of 24 March 2022, the EU Court of Justice ruled that the list of ingredients of a foodstuff containing a vitamin does not have to mention the […]
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance) This Regulation aims to achieve a high level of protection of health for patients and users while ensuring the smooth functioning of the internal market as regards medicinal products, […]
COMMISSION IMPLEMENTING REGULATION (EU) 2021/1280 of 2 August 2021 – as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council Article 93(1)(j) of Regulation (EU) 2019/6 requires the holders of a manufacturing authorisation to use only active substances which […]
REGULATION (EU) 2022/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices Current stage – In Force Who is in charge – European Parliament and Council of EU The Covid-19 pandemic has highlighted […]
The EU rules on product safety are defined within the General Product Safety Directive (GPSD) 2001/95. Under this directive a product can only be deemed safe if it meets all statutory safety requirements under European or national law. The EU legislator is seeking to repeal the GSPD and amend regulation 2012/1025 that deals with the […]
C‑623/13, Ministre de l’Économie et des Finances v Gérard de Ruyter, 26 February 2015 The European Court of Justice (ECJ) has ruled that French legislation which requires foreigners who reside in France and who are employed by a company located in another EU Member State – and who are thus submitted to the social […]
