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Practice Industry: Healthcare & Pharmaceuticals, Industrial & Manufacturing, Life Sciences
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Afridi & Angell | April 2020

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 ...

Due to the reforms and additions to the General Health Act in matters of obesity and labeling of food and non-alcoholic beverages setting a frontal warning system, published in the Federal Official Gazette (Spanish Acronym - DOF) on November 8, 2019 ...

Dykema | April 2020

The coronavirus pandemic has impacted the food industry, just as it has many others. The good news is that food-to-person transmission of the disease does not seem to be a risk. The challenge remains keeping workers safe from airborne and surface transmission. However, the FDA and the USDA have provided guidance and recommendations to food producers to deal with COVID-19, links to which have been provided below. The guidance focuses on stopping the person-to-person spread of the disease ...

Brigard Urrutia | March 2020

Temporary flexibility of the terms of adjustment of guarantees and the term to carry out audits to the Reliability Charge was defined. The Energy and Gas Regulation Commission, seeking to guarantee the proper provision of electric power service, decrees that the value of the guarantee in Article 31 of CREG Resolution 061 of 2007 will not be adjusted in the scenario presented in paragraph 2, numeral 3: 3 ...

PLMJ | March 2020

Faced with the COVID-19 pandemic, the Portuguese National Authority for Medicines and Healthcare Products (“INFARMED”) and the Directorate-General for Health (“DGS”) have issued guidelines for pharmacies. These guidelines address, in particular, the way pharmacies operate and manage medicines ...

Wardynski & Partners | March 2020

In Poland, the National Appeal Chamber upholds the effectiveness of the rules guaranteeing transparent and non-discriminatory access to public procurement contracts within the EU. Member states are required to ensure contractors the consideration of review procedures concerning the award of public contracts, as is clear from the Remedies Directive. The task of the National Appeal Chamber (KIO) is to effectively and quickly eliminate infringements in public procurement cases ...

Wardynski & Partners | March 2020

Public procurement is one of the biggest driving forces of the economy. Contract performance during the epidemic may be impeded, but ongoing public procurement proceedings should not be stopped just because people are currently working mainly at home ...

Waller | March 2020

On March 30th, the Centers for Medicare and Medicaid Services (CMS) announced a number of regulatory reforms aimed at giving healthcare providers more tools to combat COVID-19 ...

Waller | March 2020

On March 30th, the Centers for Medicare and Medicaid Services (CMS) announced a number of regulatory reforms aimed at giving healthcare providers more tools to combat COVID-19 ...

Dinsmore & Shohl LLP | March 2020

On March 25, 2020, Governor Jim Justice signed into law House Bill 4497, which shall be known as The Alex Miller Law. The Alex Miller Law will take effect June 5, 2020, but the mandated requirements do not take effect until the 2021-2022 school year. Alex Miller, was a Roane County football player who collapsed and died during a high school football game. The Alex Miller Law (W. Va. Code 18-5-25c) requires defibrillators (AED devices) at certain events by the 2021-2022 school year ...

Dinsmore & Shohl LLP | March 2020

As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements. In this context, the U.S ...

Dinsmore & Shohl LLP | March 2020

In an effort to streamline the provision of COVID-19 patients’ Protected Health Information (PHI) to public health authorities, the United States Department of Health and Human Services Office for Civil Rights (OCR) recently published practical guidance explaining the methods by which Health Insurance Portability and Accountability Act (HIPAA) Covered Entities may disclose COVID-19 patient PHI to law enforcement, first responders, and public health authorities ...

Dinsmore & Shohl LLP | March 2020

The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S ...

Dinsmore & Shohl LLP | March 2020

With the onset of COVID-19, certain areas of academic and government-fueled research are exploding. However, universities and governments at all levels are also scaling down nonessential research tasks and limiting the enrollment of essential new human subjects or new animal experiments.[1] Similarly, private companies may be suspending or cancelling their research projects in an attempt to conserve financial resources and accommodate researchers working from home ...

The spread of the highly contagious coronavirus has reach pandemic status. Over 550,000 cases have been confirmed across more than 175 countries, and the United States now has over 86,000 confirmed cases across all 50 states and four territories. In other countries, the threat of coronavirus has already impacted prison operations — lockdowns have been implemented in Italy and thousands of prisoners were released in Iran ...

Hanson Bridgett LLP | March 2020

As a growing number of the workforce is being affected by the COVID-19 pandemic, employers are raising several benefit related questions, particularly with respect to group health plans. The Employee Benefits Group at Hanson Bridgett will be providing updated information on possible issues arising in the benefits area through Benefits Alerts and postings on Hanson Bridgett's Online COVID-19 Resource Center ...

Wardynski & Partners | March 2020

The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic ...

PLMJ | March 2020

In some areas, intellectual property will experience a period of slowdown in activity, at least in the near future. We look at this in more detail below. However, this does not mean mandatory registration of industrial property will come to a halt because, with many bodies, including the Portuguese INPI (National Institute of Industrial Property), registration is done online ...

Cechova & Partners | March 2020

Pharmaceutical companies are meeting with numerous legal challenges resulting from the ongoing COVID-19 pandemic and the corresponding Government measures. Among the most discussed topics are the legal obligations relating to availability of medicinal products, securing of medicinal products for treatment of patients with COVID-19, control over the distribution channel, clinical trials, and relations with healthcare professionals ...

Haynes and Boone, LLP | March 2020

The British government has adopted stringent measures to reduce the spread of the novel coronavirus effective from 23 March 2020[1], including a nationwide lockdown, closure of non-essential shops and public venues and mandatory social distancing. The general rule is that people should stay at home, but workers can travel to and from work if they cannot perform their work from home[2] ...

Brigard Urrutia | March 2020

In recent days, COVID-19 has been the greatest destabilizer worldwide. The World Health Organization defines coronavirus as an extensive family of viruses that cause respiratory infections that can range from common cold to serious health complications such as Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) ...

Brigard Urrutia | March 2020

INVIMA’s specialized board for Medical Devices and other technologies issued a list of declared as Non-Available Vital Products to attend the emergency arising from COVID-19, which means that the import and / or local distribution of said products will be allowed in Colombia without having a Marketing Authorization ...

Brigard Urrutia | March 2020

Due to the preventive isolation order issued through Decree 457 of March 22nd, 2020 and the powers granted to INVIMA in the sense of guaranteeing the prevention, diagnosis and treatment of Covid-19, within the current state of Economic, Social and Ecological energency ...

Carey | March 2020

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 ...

Carey | March 2020

In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...

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