With a decision published in the EU Official Journal on 31 July 2021, the European Commission confirmed that the EU Portal and Database have achieved full functionality. This implies that Regulation (EU) No. 536/2014 on clinical trials will be applicable as of 31 January 2022, in accordance with the provisions of Article 99 of the same Regulation.
With judgment No. 5212 of 9 July 2021, the Council of State confirmed the decision of the Italian Medicine Agency whereby the latter requested a pharmaceutical company to remove from the package leaflet of an over-the-counter medicine all references to the indication concerning spastic-painful symptoms of the genitourinary tract, considering the relevant data inadequate to support such an indication.
Taxpayers have the right to appeal HMRC’s decisions to the Tax Tribunal in most circumstances. In reality, many find the appeal process too arduous, time consuming and risky; resulting in taxpayers conceding or settling matters with otherwise good prospects of success. We expect that the recommendations of the Tax Law Review Committee, if implemented, will improve taxpayers’ access to justice and level the playing field between taxpayers and HMRC.
This 1 hour session will explore the issues you might anticipate arising in light of emerging trends to litigation across Europe and offer some practical thoughts on how to minimize or avoid the risk of litigation when effecting changes to your distribution and supply chain. We are delighted to invite you to join us on Tuesday October 5 via Zoom as we discuss managing your supply chain. Click here to register and receive joining details.
In late July 2021, the UK Government set out a new strategy on disability inclusion with Boris Johnson claiming “Our new National Disability Strategy is a clear plan – from giving disabled people the best start in school to unlocking equal job opportunities, this strategy sets us on a path to improve their everyday lives.” In this article Baker McKenzie associates consider the employment aspects of the strategy and the legal implications of them. They also consider practical steps employers can take to better understand and address disability inclusion within the workplace.
In the run up to the United Nations Climate Change Conference (COP26), the UK has published its first ever Hydrogen Strategy. The strategy promises to deliver 9,000 jobs, GBP 4 billion in investment and new export opportunities by creating a thriving low-carbon hydrogen sector in the UK over the next 10 years and beyond. It builds on the prime minister’s determined Ten Point Plan for a Green Industrial Revolution by depicting how the UK government will work with industry to meet its ambition for 5 gigawatts of low-carbon hydrogen production capacity by 2030.
On 31 August 2021 the European Commission launched a consultation on the operation of Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities targeted at stakeholders involved in such activities.
An overarching theme of COP26 and a priority of the UK presidency is to enhance climate change ambition. As countries set enhanced climate plans and pledges for 2030 (called “nationally determined contributions”) and set net-zero targets for 2050 (or earlier), they are also looking to the private sector to participate in this “race to zero.
17 December 2021 is the deadline for all Member States to transpose the new Whistleblower Protection Directive 2019/1937, which obliges businesses with over 50 employees to have a reporting channel. It should be noted that the aim of these new regulations is to exploit the potential for whistleblower protection to strengthen enforcement and set standards for strong protection against any reprisals.
On 11 March 2021, the Court of Justice of the European Union issued its ruling in case C-812/19. The case concerned the VAT treatment of the supply of services from a head office, which was part of a VAT group in Denmark, to its branch in Sweden.