We would like to inform you about several important news items, in the pharmaceutical industry, at the beginning of 2021. The Rules of registration and assessment of medicines for medical use in the EAEU come into force According to the Decision of the Eurasian Economic Commission Council (“EEC”), dated November 3rd 2016 No ...
Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
Physicians, physician assistants, and advance practice nurses who have sought to treat opioid-addicted patients with Schedule III-V Controlled Substances that have been approved by the United States Food and Drug Administration for that indication have had to apply for a waiver under the Drug Addiction Treatment Act of 2000. Eligible medications are presently limited to buprenorphine-containing products such as Suboxone and Subutex ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
In a recent press release, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) announced five additional guilty pleas relating to a $1 billion telepharmacy fraud scheme. However, unlike many health care fraud cases, this particular case was investigated over the course of three years by an interagency team comprised of personnel from HHS/OIG, the U.S. Department of Justice (DOJ), the U.S. Food and Drug Administration (FDA), the U.S ...
Late last year, the Environmental Protection Agency (“EPA”) issued a draft guidance intended to assist regulated entities and permitting authorities in applying the U.S. Supreme Court’s decision in County of Maui, Hawaii v. Hawaii Wildlife Fund, concerning Clean Water Act (“CWA”) jurisdiction over discharges to groundwater ...
When Alabama’s Legislature convenes for its annual session on February 2, lawmakers will once again be asked to consider a bill that would provide certain Alabamians with access to medical cannabis ...
A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives ...
A new Royal Decree published on 21 January 2021 in the Belgian Official Gazette has temporarily extended the occupational doctor's role in combatting the Covid-19 virus ...
Welcome to the Life Sciences & Healthcare Newsletter, a publication prepared by our multidisciplinary team dedicated to the Healthcare industry, under the coordination of partners Lior Pinsky and Renata Fialho de Oliveira. INSURANCE ANS establishes operating rules for electronic administrative proceedings, effective as of end of March 2021 Andrea Piccolo Brandão In accordance with Decree No. 8,539, of Oct. 08, 2015 ("Dec ...
Following the bioeconomy trend, the National Policy of Payment for Environmental Services was published, establishing the payment for services that benefit the maintenance, recovery and improvement of ecosystemic services, such as provision services (e.g. water supply), and regulation services (e.g. climatic change programs). On January 14, 2021, the Federal Law No. 14,119 ("Law") establishing the National Policy of Payment for Environmental Services ("PNPSA") was published ...
This year it may be easier to predict developments in environmental law and policy than in 2020. The main reason for that is that there are several key developments that should have happened in 2020 but didn’t because of the Covid-19 pandemic. Here are our top five predictions. 1. The Environment Bill The Environment Bill is a key piece of legislation that establishes a post-Brexit environmental governance framework for England ...
On February 1, 2021, amendments to B.C.’s Environmental Management Act will come into effect that will introduce new reporting requirements in relation to lands that have been used for specified commercial or industrial uses (the Stage 13 Amendments) ...
On February 1, 2021, new reporting requirements in British Columbia will apply to owners and operators of lands that have been used for specified commercial and industrial uses. These reporting requirements will also trigger environmental investigation requirements to determine whether or not the lands are contaminated. While the B.C ...
Two federal cases in the Northern District of Ohio recently reached very different conclusions on whether the state’s COVID-19 shutdowns of restaurants permit valid claims for business interruption insurance coverage. Reviewing essentially the same facts and policy provisions, one court found for the insurer, holding no coverage to exist. The other found for the policyholder, awarding coverage. The opposite results will no doubt lead to further upcoming appellate activity in Ohio ...
On February 1, 2021, amendments to B.C.’s Environmental Management Act and the Contaminated Sites Regulation (the Stage 13 Amendments) will come into effect which will affect the application process for redevelopment of lands formerly used for specified industrial or commercial uses ...
CONGRESS PASSES TRADEMARK MODERNIZATION ACT LEGISLATION In December 2020, the U.S. Congress took action that will have a significant effect on brand holders. At the end of the year, Congress passed the Trademark Modernization Act (“TMA”) that, inter alia, provides additional tools to the USPTO to respond to the rise in improper behavior in trademark filings including filing fraudulent claims of use ...
The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021. At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules ...
Article PDFJust when businesses thought they had figured out their Proposition 65 compliance strategies, the State of California, through the Office of Environmental Health Hazard Assessment (OEHHA), has proposed a substantial change that will drastically limit the use of the short-form safe harbor warning first authorized in 2018 ...
On January 20, 2021, Supreme Decree No. 8/2019 of the Ministry of the Environment was published in the Official Gazette, setting forth collection and valorization goals and other associated obligations for tires in order to prevent the generation of such wastes and to promote their reuse, recycling or other types of recovery, in the context of Law 20,920 on Extended Producer Responsibility. Regulated object: tires This decree is applicable to tires introduced into the market ...
This is the first in our series of articles in which we will look at how Brexit and the EU-UK trade deal impacts research and development. In July 2020, the Government published its Research and Development Roadmap, which sets out the UK’s ambitious long-term objectives for investment in science and research to deliver economic growth and societal benefits across the UK ...
Effective Jan. 26, 2021, all air passengers traveling to the United States will be required to get a viral test for current infection within the three days before their flight to the U.S. is scheduled to depart, and provide written documentation of their laboratory test results (paper or electronic copy) to the airline ...
