On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 401/23 the technical guide for the sanitary registration of allergens with the purpose of establishing the guidelines and requirements for the sanitary registration of these products (the "Guide") ...
On October 29, 2021, the following resolutions were published in the Official Gazette: Exempt Resolution No. 1,080 of the Undersecretary of Public Health amending Exempt Resolution No. 994, of 2021, of the Ministry of Health, which establishes the fourth Step-by-Step Plan; and Exempt Resolution No. 1,079 of the Undersecretary of Public Health, which amends Exempt Resolution No. 672, of 2021, of the Ministry of Health, which establishes the Protected Borders Plan ...
Q&A procedures before the Public Health Institute (ISP) May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds ...
This new Workplaces Manual covers all General Preventative Measures set for the by the following: Governmental Agreement 79-2020 Ministerial Agreement 146-2020 Presidential provisions in force Provisions of the Ministry of Public Health and Social Assistance Guide to the identification of occupational hazards by Covid-19 and preventive measures in the workplace - IGSS Regulation of Occupational Health and Safety The Manual covers the specifics of all factors involved in halting
Historically there has been relatively little enforcement focus on the typical physician-ownership model used by many ambulatory surgery centers (ASCs). A qui tam lawsuit filed recently against an ambulatory surgery center company based in Nashville, however, indicates that qui tam relators are leaving no stone unturned as they look for cases. Although the federal government has declined to intervene in U.S. ex. rel Thomas Reed Simmons v. Meridian Surgical Partners, et ...
As part of Rail Safety Week 2023, Health and Safety specialist Hayley Saunders looks at personal liability and how employees across all levels of a business can make a difference by positive individual contribution to workplace culture. Below is a summary of key takeaways from the webinar. Responsibility for workplace safety rests with employers and employees alike ...
Haynes and Boone, LLP Counsel Raquel Alvarenga talked with HR Magazine about continued COVID-19-related accommodations for vaccinated employees.Below is an excerpt:Many businesses have developed policies on providing reasonable accommodations to employees who refuse to get a COVID-19 vaccine for religious or disability-related reasons. Employers shouldn't forget that fully vaccinated workers may need accommodations, too.In recently updated guidance, the U.S ...
Wellbeing, selfcare is key in order to give the world the best of you, not what’s left of you…. Shoosmiths’ Learning & development Manager, Yvonne Oakenfull gives us an insight into HeartMath – how different patterns of the heart activity have different effects on your thoughts and behaviours ...
New measures for state contracting for economic reactivation. Through Decree 579 of 2021, issued on May 31 by the National Planning Department, certain transitory paragraphs enshrined in Decree 1082 of 2015 or the sole Regulatory Decree of the Administrative Planning Sector, were replaced in matters of state contracting ...
The Department of Health and Human Services recently released a letter that stated that using a single ventilator for two patients should be considered “an absolute last resort.” Of course, this statement assumes that a ventilator exists in the first place, and it says nothing about how to deal with several more than two patients needing the same ventilator. This, however, is only the tip of proverbial iceberg ...
Employment Tribunals have a duty to make reasonable adjustments where a participant is disadvantaged, for example due to disability, to ensure fairness in proceedings. We share our recent experiences of how the Tribunals apply this duty in practice ...
Two recent opinions of the California Court of Appeal address the enforcement of arbitration agreements in the senior care setting when executed by someone other than the resident. The Court of Appeal's decisions in Valentine v. Plum Healthcare Group, LLC (2019) 37 Cal.App.5th 1076 (Valentine) and Lopez v. Bartlett Care Center LLC (2019) ____ Cal.App ...
The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies. The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...
by Bryan G. Scott and Elizabeth K. Strickland Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices ...
In a short three-week period, the U.S. Department of Justice announced three large, multi-million dollar False Claims Act settlements involving Stark Law violations. Each of the three cases alleged that health systems compensated physicians in excess of fair market value, and in excess of collections for services personally performed by those physicians, in order to induce referrals ...
As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
On 30 May 2020, the Abu Dhabi Media Office posted through Twitter that the Department of Government Support has eased restrictions on some activities and issued a set of guidelines for working from and visiting government entities in Abu Dhabi. The guidelines below come into effect from today, 1 June 2020, and are limited to individuals between the ages of 12 and 60 ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
Private healthcare provider Bupa has been ordered to pay a purported record £1.04 million penalty (fine and costs combined) after admitting fire safety failings. London Fire Brigade, prosecuting, said it was the "highest ever fine for fire safety breaches in the UK, [highlighting] the seriousness of Bupa's failure to protect a vulnerable resident in its care ...
Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs. However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“Regulation”) came into force on 31 January 2022. The Regulation was adopted by the European Parliament in 2014 and released in May of the same year. It was subsequently officially published in the Official Journal of the European Union on 31 July 2021 and came into force six months after that date ...
As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services.Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health ...
With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are again confronted with the fact that a EU common policy in the healthcare field is quasi inexistent. This is equally so in respect of the pricing and reimbursement of medicines ...
Many employers are facing diminishing revenues during the current Covid-19 epidemic. Many of those employers also face the need to reduce overhead. To provide some relief for employers, the Minister of Human Resources and Emiratisation promulgated Ministerial Resolution No. 279 of 2020 (the “Resolution”) on Employment Stability in Private Sector during the Period of Application of Precautionary Measures to Curb the Spread of Novel Coronavirus ...
