COVID-19 News, Member News

Wilson Sonsini | FDA Issues Draft Transition Plans for Medical Devices Commercialized Pursuant to EUA or Enforcement Discretion Policy During COVID-19 Emergency

On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization (EUA) or the FDA’s Enforcement Policies during the Coronavirus Disease 2019 (COVID-19) public health emergency (COVID-19 PHE). The draft guidance for EUAs can be located here, and the draft guidance for devices commercialized under the FDA’s COVID-19 Enforcement Policies can be located here. This alert provides an overview of the draft guidance(s). Overview The...

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Chapter News

French presidency of the Council of the EU: 1 January – 30 June 2022

The priorities of France's presidency are reflected in its motto: 'Recovery, strength and a sense of belonging': recovery, to enable Europe to support the ecological and digital transitions strength, to defend and promote our values and interests a sense of belonging, to build and develop a shared European vision through culture, our values and our common history According to the speech given on 9 December 2021 by French President Emmanuel Macron to present the priorities of the French presidency, the activities...

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Chapter News, COVID-19 News

EU Digital COVID Certificate: EU Commission adopts binding acceptance period of nine months for vaccination certificates

Today, the Commission adopted rules relating to the EU Digital COVID Certificate, establishing a binding acceptance period of 9 months (precisely 270 days) of vaccination certificates for the purposes of intra-EU travel. A clear and uniform acceptance period for vaccination certificates will guarantee that travel measures continue to be coordinated, as called for by the European Council following its latest meeting of 16 December 2021. The new rules will ensure restrictions are based on the best available scientific evidence as well...

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Chapter News

The EU Commission proposes the next generation of EU own resources

The EU Commission has today proposed to establish the next generation of own resources for the EU budget by putting forward three new sources of revenue: the first based on revenues from emissions trading (ETS), the second drawing on the resources generated by the proposed EU carbon border adjustment mechanism, and the third based on the share of residual profits from multinationals that will be re-allocated to EU Member States under the recent OECD/G20 agreement on a re-allocation of...

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Chapter News

2021 in review: A year of transitions

Looking back, I would define 2021 as a year of transitions. Geopolitical changes have intensified with power politics repeatedly challenging the EU and its values. We must respond with all the determination we can muster. The pandemic has carried on longer than we imagined a year ago and the omicron variant is yet again requiring the introduction of major restrictions and threatening the recovery. Still, we know that vaccines are making a major difference. Thanks to the common purchase mechanism,...

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Member News

Stibbe | EU Commission presents proposals for directives against shell entities and ensuring a global minimum level of taxation

On 22 December 2021 the European Commission (hereinafter: ‘EC’) presented two legislative proposals for EU directives, one to introduce a global minimum corporate tax rate and one to target EU shell entities. The key aspects of both proposals are discussed below. 1. Proposal for a Directive on a minimum effective tax rate of 15% The proposal for a directive on ensuring a global minimum level of taxation for multinationals and large-scale domestic groups in the EU introduces a minimum effective tax rate...

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Member News

Arendt Medernach | EU Commission issues draft directives on substance requirements and minimum taxation

On 22 December 2021, the EU Commission issued two major draft directives that are expected to have a significant impact on EU corporate taxpayers. On 22 December 2021, the EU Commission issued two major draft directives that are expected to have a significant impact on EU corporate taxpayers: a proposal for a Council Directive laying down rules to prevent the misuse of shell entities for tax purposes and amending Directive 2011/16/EU (the “Unshell Proposal”); and a proposal for a...

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Member News

Greenberg Traurig | Third Update on Forced Labor for Imported Products

On Dec. 16, Congress voted unanimously to pass the Uyghur Forced Labor Prevention Act, and President Biden is expected to sign the bill into law before the end of the year. The Act is the strongest legislation yet in response to forced labor in the supply chain of imported products and their components.  The Act creates a “rebuttable presumption” that goods produced or manufactured in Xinjiang, or by certain entities, are made with forced labor and are prohibited from...

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Member News

Loyens & Loeff | OECD publishes Pillar Two model rules on IIR and UTPR

On 20 December 2021, the OECD released its Pillar Two model rules, also referred to as the “Anti Global Base Erosion” or “GloBE” rules, for participant jurisdictions to implement most of the Pillar Two rules. These rules seek enforcing a minimum 15% effective tax rate on profits earned by large multinational enterprises in each jurisdiction where they realise profits. The entry into force is targeted for 2023. The publication of the GloBE rules lifts the veil on a range of...

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Member News

Vulcan Insight | Sixth Eastern Partnership Summit takes place in Brussels

The leaders of the EU, of the EU member states and of the Eastern Partnership countries met for the sixth Eastern Partnership summit in Brussels on Wednesday. The eastern partners present at the summit were Armenia, Azerbaijan, Georgia, the Republic of Moldova and Ukraine. The leaders emphasised their joint determination to uphold the fundamental values they share, such as strengthening democracy and the rule of la and protecting human rights and fundamental freedoms, including the rights of persons belonging to minorities. Tensions with Russia loomed large however as Ukrainian President Volodymyr Zelenskiy urged...

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