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
In April 2021, the European Commission proposed the EU Artificial Intelligence Act, a first-of-its-kind regulation by any global regulatory authority. The proposed Act is intended to establish harmonized rules on artificial...more
Today, on Monday, March 20, 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional provisions for certain...more
Erneute Lockerung der Insolvenzantragspflicht durch das SanInsKG -
Mit dem „Gesetz zur vorübergehenden Anpassung sanierungs- und insolvenzrechtlicher Vorschriften zur Abmilderung von Krisenfolgen“ (kurz: Sanierungs- und...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
The German Supply Chain Due Diligence Act: what does it mean for companies with a presence in Germany or doing business with German customers?
On 1 January 2023, the German Supply Chain Due Diligence Act (“Gesetz über die...more
1/6/2023
/ Corrective Actions ,
Documentation ,
Due Diligence ,
Enforcement ,
Export Controls ,
Germany ,
Human Rights ,
New Legislation ,
Risk Management ,
Self-Reporting ,
Supply Chain
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
Humor and irony are outstanding tools to achieve a high level of attention, and praise be to those who can use these tools skillfully. Since parody and satire involve an imitation of style and the exposure and criticism of...more
Das Bundesministerium für Arbeit und Soziales bringt das Gesetz zu Sorgfaltspflichten in der Lieferkette auf den Weg - bisheriger Goodwill wird zur Pflicht: Ab 2023 werden Unternehmen verpflichtet, Zulieferer und Kunden auf...more
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 France, Ordinance No 2017-49 of 19 January 2017 significantly modified the rules governing payments from life sciences companies to the healthcare sector. After more than three years, on June 15, 2020, Decree No 2020-730...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
Manufacturers of food products need to meet the requirements of food laws and expectations of consumers, who are seeking more information about the healthfulness of food products. Many manufacturers are responding by...more
When structuring and assessing transactions in the food and beverage sector in a European context, a purchaser must consider and evaluate several EU-specific requirements in order to ensure a successful transaction with...more
5/9/2019
/ Acquisitions ,
Advertising ,
Beverage Manufacturers ,
Change of Ownership ,
Corporate Branding ,
Due Diligence ,
EU ,
Final Judgment ,
Food Manufacturers ,
Intellectual Property Protection ,
Labeling ,
Mergers ,
Regulatory Standards ,
Sale of Assets ,
Settlement Agreements ,
Stock Purchase Agreement ,
Trademarks
On November 21, 2018, the data protection authority of the German state of Baden-Württemberg (“LfDI”) imposed a fine of EUR 20,000 on a German social media company for failing to encrypt user passwords, the first fine issued...more
The European Data Protection Authorities, assembled in the European Data Protection Board (“EDPB” or “Board”), met at their third plenary meeting held on the 26th of September. At its meeting, the Board agreed on common...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 June 9, 2018, the new Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful...more