The pharmaceutical industry continues to be a highly regulated sector that has a very important presence in Argentina. Its financial results are highly affected by the influence of agreements entered into with social security organizations – mainly the social security organization that covers retired people – and private health insurance companies ...
The Ministry of Health and Social Protection issued Resolutions 677, 679 and 681 adopting the biosecurity protocols for the control and management of COVID-19 risk in the transportation, transportation infrastructure and games of luck and chance sectors. These protocols are complementary to the general biosecurity protocol adopted through Resolution 666 of 2020 and to other measures implemented by corresponding companies ...
INFARMED and the DGS have published a set of guidelines for manufacturers and wholesale distributors of medicinal products for human use. The aim of these guidelines is to ensure supply to the domestic market and, at the same time, to prevent the spread of Covid-19 and protect the employees of these operators ...
The rapid spread of the new Coronavirus (SARS-CoV-2) and the Covid-19 pandemic have led to a very significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), and there was insufficient supply to meet existing needs during the state of emergency and the period that will immediately follow it ...
As the contagion rate and death toll caused by the Covid-19 emergency (“Covid-19”) continues to decrease, on 26 April 2020 the Prime Minister announced in a press conference the measures adopted to ease the lockdown during the so-called “phase 2”. The new measures are reflected in the Prime Minister Decree dated 26 April 20201 (the “26 April 2020 Decree”) ...
The Bay Area counties of Alameda, Contra Costa, Marin, San Francisco, San Mateo, and Santa Clara, and the City of Berkeley have jointly issued new Shelter-in-Place orders superseding their existing March 31, 2020 Shelter-in-Place orders ...
Key Points: EPA is marching forward with its plans to prevent sham COVID-19 cleaners and disinfectants from entering the marketplace. Manufacturers should continue to adhere to EPA's policy regarding products that make disinfectant efficacy claims. EPA warns consumers against injecting disinfectants into their bodies. On April 23, 2020, the U.S ...
Key Points A federal district judge has invalidated the Army Corps of Engineers Nationwide Permit 12 for failure to comply with the Endangered Species Act, in response to a case filed against the notorious Keystone XL pipeline. As a result of the decision, the Army Corps has halted new and pending approvals under the permit, which is required for construction projects that will discharge dredged or fill material into waters of the United States ...
Since the coronavirus pandemic began, the volume of counterfeit goods produced by Chinese manufacturers appears to be on the rise again. While counterfeit goods have been a challenge that online retailers have been fighting for years, the risk has become greater in the COVID-19 era when more consumers are turning to online shopping. Counterfeit goods result in lost revenue and reputational harm to retailers ...
Since the coronavirus pandemic began, the volume of counterfeit goods produced by Chinese manufacturers appears to be on the rise again. While counterfeit goods have been a challenge that online retailers have been fighting for years, the risk has become greater in the COVID-19 era when more consumers are turning to online shopping. Counterfeit goods result in lost revenue and reputational harm to retailers ...
The U.S. Supreme Court creates a test for when discharges to groundwater trigger NPDES permitting requirement, but its failure to include a bright line will make it difficult to predict whether a particular situation meets that test ...
It might seem that in the time of the "coronavirus", everything revolves around veils, disinfection or restriction of operation of various production facilities, and energy is talked about only in connection with the need to keep the elements of critical energy infrastructure running ...
The Government issued new regulations setting the guidelines and adopting the biosecurity protocol for the operation of the manufacturing industry The Ministry of Work issued Resolution 675 adopting the biosecurity protocol for the management and control of COVID-19 risk in the manufacturing industry. This protocol is complementary to the protocol adopted through Resolution 666 of 2020 and to other measures adopted in each factory ...
Key Points: An executive order from the governor's office modifies California Environmental Quality Act ("CEQA") noticing procedures, requiring local agencies to take extra steps to notify the public that environmental review processes are underway or have concluded for development projects. Extra steps include posting notices on agency websites and active outreach to interested parties ...
If you have been keeping a close eye on the ongoing discussions relating to Brexit, you will recall our earlier ENSight where we reported that the United Kingdom Intellectual Property Office (“UKIPO”) provided some clarity on how European Union (“EU”) trade mark registrations will be treated on Brexit ...
The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the world struggles to adjust to the new reality of social distancing and self-quarantining ...
Key Points A discharge of pollutants to groundwater may require a permit under the Clean Water Act. The new “functional equivalent of a direct discharge” test will be difficult to apply. It will be a long and arduous process to reach uniformity as agencies, courts, and the regulated community try to figure out how to proceed on a case-by-case basis. On April 23, 2020, the Supreme Court published its much-awaited opinion in County of Maui v ...
INVIMA will prioritize the procedures for pharmaceutical products identified as essential for the treatment of symptoms and complications of COVID-19 ...
In the midst of the COVID-19 waves, the EU Commission rejected the delay proposals on the Emission Trading Scheme (ETS)’s mandatory annual deadlines ...
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 ...
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 ...
In recognition of the ability to detect the Coronavirus (COVID-19) in sewage and the critical role of basic hygiene in combatting COVID-19, the Minister of the Department of Human Settlements, Water and Sanitation has published directions in terms of the Disaster Management Act, 2002. The Directions implement the emergency procurement of water supply and sanitation services to identified areas to combat the spread of COVID-19 ...
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”) ...
