Earlier this year, the European Chemicals Agency (ECHA) published a proposal for a ban on the production, use and placing on the market (including import) of at least 10,000 per- and polyfluoroalkyl substances (PFAS)....more
On Friday, January 6, 2023, the European Commission adopted a proposal to give more time to certify medical devices in hopes of mitigating the risk of shortages in the European Union (EU). The proposal introduces a longer...more
On November 17, 2022, the Court of Justice of the European Union (CJEU) found in its latest principal judgment (Novartis v. Abacus, case file C-147/20) that the reboxing of parallel imported medicines in the European Union...more
In the European Union (EU), we find a lot of judgments concerning the distinction between medicinal products and food supplements on both EU and member state levels. Now a third category — novel food — is in the focus of...more
On March 25, 2022, U.S. President Joe Biden and European Commission President Ursula von der Leyen announced that the U.S. and the EU have reached a political agreement in principle on a new Trans-Atlantic Data Privacy...more
The EU is working on its next move toward sustainability and plans to oblige companies to address adverse sustainability impacts in their own operations and in their value chain. While the European Commission is working on...more
2/23/2022
/ Corporate Governance ,
Distributors ,
Duty of Care ,
Environmental Policies ,
EU ,
European Commission ,
Food Manufacturers ,
Human Rights ,
Risk Management ,
Suppliers ,
Supply Chain ,
Sustainability
Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more
2/9/2022
/ Clinical Trials ,
Data Privacy ,
Deadlines ,
Disclosure Requirements ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Life Sciences ,
Member State ,
New Regulations ,
Proposed Regulation ,
Reporting Requirements ,
UK
EU Regulation on Artificial Intelligence -
On April 21, 2021 the European Commission published its Proposal for a Regulation on Artificial Intelligence, the first ever legal framework on AI. With its Proposal the European...more
In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more
The United Kingdom (UK) left the European Union (EU) on 31 January 2020. While the EU and the UK lastly agreed on a withdrawal agreement and thus can avoid an unregulated Brexit, specific rules for trading UK goods on the EU...more
2/13/2020
/ Beverage Manufacturers ,
EU ,
European Commission ,
Exports ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
GMO ,
Member State ,
Organic ,
Regulatory Oversight ,
Regulatory Requirements ,
UK Brexit
The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more
On September 5, 2018, the European Commission (“EC”) published its draft decision on whether Japan’s 2003 Act on the Protection of Personal Information (“APPI”) provides protection equivalent to the protection of personal...more
On April 11, 2018, the European Commission presented its Proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain (COM(2018)...more
On April 23, 2018, the European Commission issued a proposal for an EU Directive on the protection of persons reporting on breaches of EU law (the “Directive”). The Directive is designed to shield persons who report breaches...more