We would like to provide you with an update on some changes in the legal regulation of medicines in Russia made due to dynamic spread of the coronavirus (COVID-19) ...
In order to allow the importation of medicines and other products for human health,during the State of Emergency, the National Directorate of Pharmacy and Drugs (DNFYD) of the Ministry of Health, has issued Resolution 280 of April 6, 2020 published in Official Gazette No ...
New products related to the health emergency by COVID-19 are declared as Non-Available Vitals. Since the issuance of Minute Num. 3 dated March 24, 2020, the Colombian Sanitary Authority, INVIMA, has declared certain products, subdivided in 16 categories, as NON-AVAILABLE VITALS, which as such, can be commercialized without a sanitary registration ...
In response to the economic impact of the COVID-19 pandemic, the federal government has passed several new laws to provide trillions of dollars of funding to affected businesses and individuals. But this also means there are new compliance considerations for entities receiving federal funds, especially as it relates to the False Claims Act’s “false certification” theory of liability ...
The COVID-19 pandemic has had a disproportionate impact on skilled nursing and assisted living facilities. While the following CMS recommendations and guidelines identify nursing homes as the target recipients, they are applicable to all facilities that receive Medicare and Medicaid funds, and are therefore subject to CMS's oversight ...
The Costa Rica´s General Directorate of Customs issued the statement DGA-010-2020, which expands the list of products for surgical use that have export and re-export restrictions, which they had initially established through directive DGA-003-2020. The products added are as follows: Mono-glasses: Mono-glasses with indirect ventilation, transparent lens, foam covered frame and adjustable headband. Ergonomic and panoramic design. HSC: 9004.90.10.00 ...
The U.S. Food and Drug Administration (FDA) recently issued a burst of COVID-19-related guidance documents to facilitate expanded availability of medical products during the current public health emergency created by COVID-19. FDA-regulated products under these temporary policies include: PPE, diagnostic tests, hand sanitizers, disinfectant devices, remote monitoring devices, ventilators, and electronic thermometers for clinical use ...
At a news conference on April 20, Governor Wolf announced he is extending his stay-at-home order until May 8, 2020. But in a nod to a construction industry that has been particularly hard-hit by the Governor’s shutdown and stay-at-home orders, Governor Wolf said he also will permit construction (both residential and non-residential construction) to resume throughout the Commonwealth on May 8, 2020 ...
Key Points: Since Governor Newsom announced a state of emergency due to the COVID-19 outbreak, private Proposition 65 enforcement has increased by about 50%. Effective April 1st, new regulations clarify how manufacturers can satisfy their Proposition 65 warning obligations. These new regulations also clarify when retail sellers assume the burden under Proposition 65 to warn Californians ...
We have previously reported on the order that adopted the extraordinary measures under the COVID-19 health emergency declaration, published on March 31, 2020 (the “Order”), and the Technical Guidelines regarding certain essential activities described in Order, published on April 6, 2020 ...
Decree Number 557 intends to take economical and tax related measures to relieve economic burden to some companies and charity and social solidarity organizations in the context of the economic emergency caused by COVID-19. Specifically, micro and small business as well as associations and solidarity non-profit organizations, will have special discounts applicable to the payment of administrative fees before the sanitary authority, INVIMA ...
The Plurinational State of Bolivia, within the framework of its governmental powers and in accordance with the Declaration of Sanitary Emergency and Quarantine established in recent days, has determined to strengthen the latest measures. The government has conviniently declared that the total quarantine, extends until April 30, 2020, maintaining the suspension of public and private activities ...
We recently discussed how the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) allocates $100 billion to the Public Health and Social Service Emergency Fund, to be distributed as relief funds to hospitals and other healthcare providers on the front lines of the coronavirus response (“Provider Relief Fund”) ...
The Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), a historic $2 trillion relief package signed into law on March 27, 2020, seeks to address the economic impact of the COVID-19 pandemic on several industries ...
As detailed in our previous alert, Texas Governor Greg Abbott recently committed to begin the gradual process of reopening businesses in Texas. On April 17, 2020, Governor Abbott issued two Executive Orders that relate to the strategic reopening of select services as the first step to open Texas in response to the COVID-19 pandemic. Impact on Retail Employers Executive Order GA 16 (“E.O ...
Another week brings another round of COVID-19-related lawsuits. Even after a month, we already can identify some early trends: refund lawsuits and second amendment claims continue to boom. A rise in takings claims may signal another trend, or a recent adverse decision from the Pennsylvania Supreme Court may throw cold water on business owners and citizens’ efforts to be compensated for government-directed impacts ...
On March 27, 2020, President Donald Trump signed into law a $2 trillion emergency relief bill to ease the economic impact of coronavirus (COVID-19) and support response efforts. The CARES Act[1] included an allocation of $80 million in funding to the U.S. Food and Drug Administration (FDA) to continue its COVID-19 response efforts. The additional agency funding will be used, in part, for the development of medical countermeasures and vaccines ...
Through data analysis, hospitals can track denials, improve appeals success rates and recoup revenue losses that threaten their very survival. Early last year, when Modern Healthcare reported that a deluge of reimbursement claim denials had driven U.S. hospitals toward a “crisis point,” it highlighted an alarming market imbalance between payers and providers ...
The continuing COVID-19 pandemic has caused an unprecedented disruption of business worldwide, and many businesses and organisations will be scouring their current contracts to identify avenues of relief. In many cases, the pages containing the force majeure clause will be the first to be turned ...
Below is a summary of key new measures that have been implemented by various UAE authorities since 15 April 2020 and the time of this inBrief, 12:00 noon on Saturday, 18 April 2020. Dubai’s National Disinfection Programme extended On 17 April 2020, Dubai’s Supreme Committee of Crisis and Disaster Management extended the 24-hour National Disinfection Programme for another week. The programme, which began on 5 April 2020, was initially scheduled to end on 18 April 2020 ...
The UAE authorities have taken a number of measures to reduce the costs that businesses are facing during the current crisis. We now report on some of the measures that have been introduced, current as of 12:00 noon on Thursday, 16 April 2020. Abu Dhabi Department of Economic Development (ADDED) Administrative Resolution No. 92 of 2020 On 14 April 2020, the ADDED issued Administrative Resolution No ...
AUTHORIZATION TO RENDER SERVICES The Secretary of Health and territorial entities will authorize, within a short period of time, and temporarily, health service providers who are registered in the REPS to: Temporarily adapt a place not destined to render health services, inside or outside their facilities. Temporarily convert or adapt a health service to render another, for which the health service provider is not authorized for. Expand the capacity of an enabled service ...
