Coronavirus Insights & Updates The information listed below is categorized by topic for your convenience and includes content from the previous week. Bradley is actively monitoring and engaging with relevant federal, state or local entities on issues related to the coronavirus. Please contact one of the authors if you have any questions. Click on a link below to view the full article, alert, blog, webinar recording or interview ...
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 ...
Over the next decade, challenges around public funding and a shift in live/work priorities will create an increasing need for public-private collaboration as we seek to rebuild and regenerate our towns and cities in a post-Covid and post-Brexit climate ...
Historically, New York State has not required the registration of investment adviser representatives (IARs). New York has adopted regulations providing registration and examination requirements for IARS. This article focuses upon the examination and registration requirements applicable to IARs of federally covered investment advisers. The newly adopted regulations became effective Feb. 1, 2021 ...
As a developing country, Indonesia is still considered to have limited Government fiscal capacity and limited state-owned enterprise (Badan Usaha Milik Negara – “BUMN”) and financial sector funding capacity indicating that domestic capacity is not sufficient to meet what is needed to finance development and support economic growth and opportunities ...
In recent years, with the continuous improvement of science and technology standards in China, the country’s cryptography technical capabilities have also begun to enter the global forefront. In turn, China has promulgated various policies and measures to fulfill its non-proliferation obligations, which have promoted the gradual implementation of control measures for the export of cryptographic technologies ...
The Minister of Communication and Informatics (“MOCI”) has finally issued MOCI Regulation No. 5 of 2020 on Electronic System Organizers (“ESO”) in the Private Sector (“MOCI Regulation 5/2020”) that serves as the new implementing regulation of Government Regulation No ...
On 30 December 2020, Bank Indonesia issued Bank Indonesia Regulation No. 22/23/PBI/2020 of 2020 on Payment Systems (“Payment Systems Regulation”). The Payment Systems Regulation is intended to serve as an “umbrella” regulation that provides a regulatory framework for the Indonesian payment systems industry. This regulation will come into force on 1 July 2021 ...
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 ...
On 14 January 2021, the Ministry of Economy and Finance issued Prakas No. 010 on “the Local Manufacturers Obligation to place devices for measuring the volume of beer and non-alcoholic drinks” (“Prakas 010”). The purpose of Prakas 010 is to establish rules and procedures for managing the use of devices which measure the volume of beer, and/or non-alcoholic beverages that are produced locally ...
On 24 December 2020 the United Kingdom (UK) and the EU entered into the UK-EU Trade and Cooperation Agreement (TCA) which will govern the relationship between the UK and the EU as of 1 January 2021. Tax consequences VAT European VAT is governed by the VAT Directive and case law by the Court of Justice of the European Union (CJEU). As a result of the Brexit the UK is now considered a third country and no longer bound by these sources ...
Traditionally, Dutch mortgage lenders have always found themselves in quite a good position in the event of their borrower and mortgagor becoming insolvent. As a firm general rule, it is fair to say that the position of a secured creditor is quite secure under Dutch law. Recent insolvency and COVID related regulations have, however, made some inroads into the Dutch secured lender’s stronghold ...
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 ...
Dr Michael Psaila, Managing Partner of Mamo TCV Advocates, underlined the firm’s commitment to the visually impaired and the Malta Guide Dogs Foundation (MGDF) in particular when he not only presented a donation but committed the firm to assisting the foundation in its legal affairs in the coming years. It was the wish of the firm, which has a staff complement of over 70 people, to select the MGDF as one of the beneficiaries of their annual charity donation ...
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 ...
The 2021 tax assessment of real and personal property will be determined by local Assessors in February, at which time a Notice of Assessment will be issued and mailed to property owners. Property owners should make sure to check the mail for a copy of the Notice in order to determine whether an appeal of their taxable value should be filed ...
The Pension Protection Fund (PPF) has published its determination for the levy year 2021 to 2022, following its autumn consultation. Ordinarily, the PPF considers matters across the levy triennium with a view to keeping the rules relatively stable on a triennial basis. However, in considering the impact of COVID-19 on schemes, the PPF wishes to take a more flexible approach with the aim of switching back to a multi-year approach in 2023/24 ...
Bank Negara Malaysia issues Licensing Framework for Digital Banks Bank Negara Malaysia issued its policy document on Licensing Framework for Digital Banks on 31 December 2020. It has indicated in its press release that up to five licences may be issued to qualified applicants and notification of the grant of licence will only be made by the first quarter of 2022 ...
Operation hours of IRB Counters during Movement Control Order (“MCO”), Conditional MCO & Recovery MCO periodThe Inland Revenue Board (“IRB”) has issued a media statement on the operation hours of its counters during the MCO, Conditional MCO and Recovery MCO period. For more information, please click here ...
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 ...
Domestic extremism is not new, but heightened law enforcement scrutiny in the wake of the Capitol riots has added yet another layer of complexity to the jobs of already challenged AML compliance professionals and investigators ...
