Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...
“Government efforts to manipulate markets and prices on consumer goods never work as intended, and in this case, would be counterproductive.” The waning days of summer signal the approaching midterm election season. Amid inflation, recession and voter discontent, it’s understandable that a group of congress members are anxious to put points on the board with a price-control scheme that they wrongly believe will lower prescription drug prices ...
On 31 August 2022, the UK COVID-19 Inquiry (“the Inquiry”) opened its second Module. Module 2 will examine the political and administrative decision making of the UK and devolved governments, with a particular focus on early 2020 ...
Dear valued clients, colleagues and friends, On 23 August 2022, the Malaysia Competition Commission (“MyCC”) launched a public consultation on the proposed renewal of a Block Exemption Order (“BEO”) in respect of liner shipping services covered under a VSA. The renewal application was made pursuant to Section 8 of the Competition Act as the earlier BEO granted expired on 6 July 2022. The press release by MyCC (“Press Release”) is accessible here ...
SyCip Salazar Hernandez & Gatmaitan (SyCipLaw) has kept its Tier 1 ranking in M&A, and in Restructuring and Insolvency, in the latest launch of the IFLR1000 rankings, the guide to the world’s leading financial and corporate law firms. Earlier this year, SyCipLaw also received Tier 1 rankings in Banking, Capital markets: Equity, Project development, and in Project finance ...
With regulations imposing mandatory vaccination for certain workers in the care sector being implemented to those same regulations being revoked some four months later, employers in this sector may well be confused as to what options are available to them ...
As all court cases do, the Supreme Court's landmark decision in West Virginia v. EPA last month addressed a specific question: whether the Environmental Protection Agency had the statutory authority to shut down power plants and reshape significant parts of the energy sector in its effort to reduce emissions. The answer was a plain and simple no. Equally clear was the court's argument, which has implications for administrative actions well beyond this case ...
Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety Current regulatory framework and scope of application The EU regulatory framework on substances of human origin (“SoHO”) is reflected in Directives 2002/98/EC for blood and 2004/23/EC for tissues and cells ...
On 21st July 2022, the COVID-19 Inquiry was opened. Module 1 will consider the extent to which the risk of a Coronavirus pandemic was properly identified and planned for and whether the UK was ready for that eventuality. In broad terms, the module will look at the UK’s preparedness for whole-system civil emergencies, including resourcing, the system of risk management and pandemic readiness ...
Ohio’s “Heartbeat” Bill became law in Ohio when the U.S. District Court, Southern District of Ohio lifted its long pending injunction after the Supreme Court overturned Roe v. Wade ...
On July 19, 2022, the Court of Claims ordered that the current Improved Workforce Opportunity Wage Act (minimum wage) and Michigan Paid Medical Leave Act (paid leave) are void and reinstated the original ballot initiatives. However, employers do not need to overhaul their policies just yet because the ruling is stayed until February 19, 2023. Pending the outcome of appeal, these changes may not go into effect at all ...
On 21 July 2022, Baroness Heather Hallett issued an opening statement in respect of the COVID-19 Inquiry ('the Inquiry'). As Chair, Baroness Hallett expressed her determination to “run the Inquiry as thoroughly and as efficiently as possible” and “to undertake and conclude the work of this Inquiry as speedily as possible so that lessons are learned before another pandemic strikes ...
Chloe, the assistance cat, has hit the headlines of several newspapers over the past few weeks, following her owner (Mr Fenn) bringing a claim under the Equality Act 2010 against Sainsbury’s supermarkets after they refused Chloe’s entry to the store. Mr Fenn has autism; a consequence of his autism is that he experiences sensory overload in busy places such as the supermarket and he states that Chloe helps him to focus ...
Peerasanti Somritutai, partner and head of the real estate practice of Kudun and Partners, represented the firm as a panelist in a webinar organized by the Legal & Tourism Hospitality Committees of the American Chamber of Commerce in Thailand (AMCHAM), to share his commercial and legal insights in relation to the topic “Financing the Return of Thailand’s Hospitality Sector” ...
A recent case provides a new approach to analysis of the enforceability of co-tenancy clauses in shopping center leases. In JJD-HOV Elk Grove, LLC v. Jo-Ann Stores, LLC (June 28, 2022, No. C094190) __ Cal.Rptr.3d __ [2022 WL 2313437] ("JJD"), the Third District Court of Appeal declined to apply penalty analysis under Civil Code §1671 to a co-tenancy clause, as the Fifth District had done in Grand Prospect Partners, L.P. v. Ross Dress for Less, Inc. (2015) 232 Cal.App ...
Even though Belgium is lagging behind when it comes to enacting specific legislation, companies doing business in Belgium should be aware of the risk of being held accountable for human rights violations or environmental pollution up or down their value chain. Human rights violations are a ‘hot’ topic and businesses are confronted with ethical challenges in this respect ...
Impact on the activity of the pharmaceutical industry At the end of 2021, two laws were published to regulate the general framework for the prevention of corruption in the activity of companies: (i) Decree-Law 109-E/2021 of 9 December, which establishes the general rules for the prevention of corruption (“RGPC”) and (ii) Law 93/2021 of 20 December, which creates rules to protect whistleblowers (“RJPDI”) ...
A summary of the key takeaways from a recent webinar on reducing scope 3 Purchased Goods & Services and Capital Goods emissions. Shoosmiths is delighted to be sponsoring United Nation Global Compact Network (UNGC) UK’s series of webinars on ‘Reducing Scope 3 Emissions’ ...
Agricultural and rural settings present significant health and safety risks, which must be carefully managed and mitigated by employers and landowners operating in the sector. The Health and Safety Executive’s (HSE) annual report into workplace fatal injuries (published on 6 July 2022) disclosed that, of the 123 workers killed in work-related accidents across the United Kingdom in 2021/22, 22 deaths occurred in the agriculture sector ...
The United States Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization that overturned Roe v. Wade’s constitutional right to abortion has had sweeping implications that affect employers, along with the general public ...
Shock to UK employment world The UK employment model was turned on its head by COVID-19 and the restrictions brought in by the Government. The seismic effects of the restrictions and the speed with which they were introduced tested the adaptability and resilience of employers and employees in a way not seen previously in the UK ...
Within hours of the U.S. Supreme Court’s decision overturning Roe v. Wade, Ohio’s Heartbeat Bill, originally passed in 2019, became effective when the U.S. District Court, Southern District of Ohio, lifted its long pending injunction against the Ohio law ...
SyCip Salazar Hernandez & Gatmaitan (SyCipLaw) is once again recognized by Managing IP’s IP STARS 2022 as a Tier 1 firm for its Patent practice. Earlier this year, SyCipLaw was also cited as a Tier 1 firm for its Trade mark work. In addition, the firm’s IP practitioners once again received outstanding rankings this year: Vida M. Panganiban-Alindogan, Partner and Head of IP Department (IPD), Trade Mark StarEnrique T ...
