1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2 ...
On January 6, 2021, the Small Business Administration (the “SBA”) and the Department of Treasury released an Interim Final Rule called “Business Loan Program Temporary Changes; Paycheck Protection Second Draw Loans” (“Second Draw Rules”). These rules announced the implementation of section 311 of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (the “Economic Aid Act”) ...
In this article we outline 12 key elements that are critical components of a rock-solid compliance program for participants in commodity markets. We start with creating a “culture of regulatory compliance,” which pervades a company from top to bottom, and then work our way through day-to-day policies and steps you can take to minimize your company’s risk of non-compliance ...
As seen in Bank Director A bank’s board of directors must answer to a variety of constituencies, including shareholders, regulatory agencies, customers and employees. At times those constituencies may have competing interests or priorities. Other times, what may appear to be competing interests are actually variations of aligned interests ...
With the twelfth anniversary of the implementation of the Sarbanes Oxley Act of 2002 (“SOX”) swiftly approaching, it may or may not be coincidental that the SEC has been involved in several SOX-related enforcement actions recently, including (i) bringing charges against the CEO and former CFO of a Florida-based computer equipment company for misrepresenting the state of its internal controls over financial reporting and (ii) awarding more than $400,000 to a whistleblower who reported fra
18 Carey Olsen lawyers recognised in Chambers Global 2024 Guide The firm's Bermuda team has been ranked Band 1 for Dispute Resolution and Band 2 for Corporate and Finance and Insurance respectively, with one client stating that the team has "highly reliable partners with extensive knowledge" who provide "exceptional service and top-level responsiveness". In the BVI, Carey Olsen has also maintained its strong rankings in Corporate and Finance and Dispute Resolution ...
The past year has seen substantial activity by the federal courts in guarding against government overreach in False Claims Act cases. One of the principal areas courts have focused on is the FCA's knowledge requirement — i.e., FCA liability can only be imposed where a person violates the act knowingly. Two recent decisions, from the U.S. Court of Appeals for the Seventh Circuit and the U.S ...
The Department of Health and Human Services (HHS) has opened up another $20 billion in funds to help hospitals and healthcare providers deal with the financial impacts of treating COVID-19 patients. The new funding round was opened on April 25 and is intended to compensate providers without regard to payer mix and to provide assistance based on March and April 2020 lost revenues ...
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The Budget. The 83rd Texas Legislative Session convened on January 8th with news of a better-than-anticipated revenue estimate, an unusually high number of new and second-term legislators, and less controversy and fanfare than observers have come to expect at the start of the biennial, 140-day process. In mid-March, only days before the bill became due, lawmakers passed and the Governor signed legislation to fill the $4 ...
On August 1, 2014, certain amendments to the Delaware Limited Liability Company Act, 6 Del. C. §§ 18-101, et seq. (the “LLC Act”), the Delaware Revised Uniform Limited Partnership Act, 6 Del. C. §§ 17-101, et seq. (the “LP Act”), and the Delaware Revised Uniform Partnership Act, 6 Del. C. §§ 15-101, et seq. (the “GP Act”) became effective ...
By: Oleksandr Voznyuk, Anastasia Usova1 General1.1 Please identify the scope of claims that may be brought in Ukraine for breach of competition law.In the context of private enforcement in respect of competition law infringements, the following types of claims may be brought before the courts:a) Claims seeking cease-and-desist orders ...
The 2015 Mergers Control Survey by Margaret Huang and Victor Chang of LCS & Partners reviewed the merger control regime in Taiwan for IFLR. 1. REGULATORY FRAMEWORK1.1 What is the applicable legislation and who enforces it?The Fair Trade Act (FTA), which entered into force in 1992, is the main legislation governing Taiwanese merger control. Merger control is enforced by the Taiwan Fair Trade Commission (TFTC) ...
The turn of the year is often a time for reflection and review.For business founders and owners this might be the one time of the year when the phone rings (less) and the inbox is more sparse ...
(Our crystal balls, that is.) "If you can look into the seeds of time, and say which grain will grow and which will not, speak then unto me … "- William Shakespeare (MacBeth) Happy New Year! 2016 was nothing if not earth-shaking in terms of unexpected developments. The – once unthinkable – departure of Britain from the European Union, was voted in by a legislature feeling increasingly un-homed in its own country ...
The results of Dykema's Annual Mergers & Acquisitions Outlook Survey are in! This annual survey tracks the marketplace to gauge the direction of the M&A market and economy for the coming year. As with previous installments of the survey, our firm canvassed leading company executives and outside advisors in the M&A space to ask them to share their observations and insights into how the U.S. economy and domestic and global matters will impact the M&A market ...
Flu season is in full swing. with the Center for Disease Control (CDC) confirming over 155,000 positive U.S. cases of influenza since Sept. 29, 2019. Simultaneously, the coronavirus COVID-19 has spread rapidly across China, with at least 70,000 confirmed cases, including 15 confirmed cases in the United States. In response, employers need to be prepared to assist employees in staying safe and complying with potential quarantines. Beginning Feb ...
Dinsmore’s Government Relations team was involved in several significant legislative initiatives affecting the health care sector during the 2019 regular session of the West Virginia legislature. Most notably, Dinsmore was involved in the passage of HB 2010, relating to foster care ...
The 2020 election in California as pertains to national politics was never in doubt, but despite being a deeply blue state, Californians continued to show their divide on taxing businesses and making major changes to the statewide tax code. Several ballot initiatives, both at the state and municipal level, would have radically altered how businesses and executives are taxed ...
Key Points In addition to five key victories for housing advocates discussed in an earlier alert, the California Senate passed many additional housing bills not included in their “Building Opportunities for All” Housing Package. Bills from the Housing Package that would have approved an affordable housing bond (SB 5), residential housing on certain commercial sites (SB 6), and local housing data reporting requirements (SB 477) all failed to win approval ...
Housing Highlights Throughout California, most single-family zoned parcels may now be split into two lots, with up to four primary residences. Density bonus applications may no longer be rejected if a proposed waiver of development standards will cause specific adverse impacts on the physical environment. Developers’ ability to lock in development standards under SB 330 and the Housing Accountability Act has been extended from 2025 to 2030 ...
