New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...
The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...
On the 27th of February 2012, the Montenegrin Parliament enacted amendments to the Law on Corporate Income Tax, the Law on Personal Income Tax and the Law on Contributions for Mandatory Social Security Contributions. These amendments were published in the Official Gazette of Montenegro no. 14/12 dated the 7th of March 2012 and came into force that same day.I ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
Contents: Recourses Seeking Rectification Under the New Business Corporations Act; You Do Business in a Province Other than Quebec: Are You Required to Register Yourself?; Resale Prices and Authorized Distributors: a Synopsis; France Arms Itself Against Trusts ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
After three days of historic oral arguments before the U.S. Supreme Court, the fate of the Affordable Care Act (ACA), the momentous 2010 health reform law, is uncertain, given robust questioning of the ability of Congress to force individuals to purchase health insurance ...
Information from Delphi’s Tax Group - The Swedish government has proposed new legislation which will entail further restrictions regarding tax deductions for interest expenses on inter-company loans. Kindly note that the proposed legislation will broaden the definition of the term "affiliated companies" ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
On March 16, 2012 the President declared the Tennessee counties of Bradley, Claiborne, Cumberland, DeKalb, Hamilton, Jackson, McMinn, Monroe, Overton and Polk federal disaster areas because of the severe storms and tornadoes that hit those counties on March 2, 2012.If you suffered an uninsured or underinsured loss of property due to the March 2, 2012 storms in a county included in the federally declared disaster areas, you could qualify for assistance from FEMA ...
Israel’s taxation system has undergone a major reform since 2003. The Income Tax Ordinance was revised as of 2003 pursuant to which an Israeli resident is taxed on worldwide income rather than the previous territorial tax system. The Taxation of Trusts Law (the "Law"), effective as of January 1, 2006, while imposing taxes on Israeli residents with respect to trusts is advantageous to foreign residents. Israel is a major international business and financial center for non-residents ...
Contents * Recourses Seeking Rectification Under the New Business Corporations Act * You Do Business in a Province Other than Quebec: Are You Required to Register Yourself? * Resale Prices and Authorized Distributors: a Synopsis RECOURSES SEEKING RECTIFICATION UNDER THE NEW BUSINESS CORPORATIONS ACT Julie Cousineau jcousineau@lavery ...
The Stage 2 Meaningful Use requirements proposed last week by CMS as part of the Medicare and Medicaid incentive programs to expand the use of Electronic Health Record (EHRs) maintain the same core and menu structure as the Stage 1 criteria. The proposed rule, however, gives providers an additional year, until 2014, to implement Stage 2 criteria ...
On 26 January 2012 and 2 February 2012, the Council of Ministers approved two Agreements with the State of Qatar and the Special Administrative Region of the People’s Republic of China and also two international Conventions to Avoid Double Taxation and Prevent Tax Evasion in the area of Income Tax with Japan and the Republic of Colombia. It should be noted that international double taxation is an obstacle to commercial relations and the free movement of goods, services, people and capital ...
Over the last few years as tax revenues have decreased and budgets have tightened, states across the country have aggressively pursued out-of-state retailers that may owe sales or use tax. From ticket sellers like StubHub, online retailers like Amazon, and mail-order companies like Scholastic Books, states are asserting that a wide variety of businesses once thought to be exempt have the substantial nexus necessary to require that they collect sales and use tax from their customers ...
Healthcare providers and other HIPAA covered entities have until Wednesday, February 29, 2012 to submit notice of breaches of unsecured Protected Health Information which affected fewer than 500 individuals during 2011. Notice must be submitted electronically to the Secretary of Health & Human Services, and separate forms are required for each data breach occurring in the course of the calendar year ...
The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...
Most of our clients are aware that Congress dramatically increased the individual gift tax exemption from $1,000,000 to $5,120,000 in 2012, and that the exemption is scheduled to revert to $1,000,000 on January 1, 2013 unless Congress takes some action. If this reduction in the gift tax exemption occurs, clients may lose an opportunity to remove a substantial amount of assets from their estates, and, with it, the opportunity to reduce estate taxes payable by their children ...
Only two days after the government’s announcement that it recovered a record-breaking $4.1 billion from its healthcare fraud enforcement efforts in 2011, the Centers for Medicare and Medicaid Services (CMS) published a draft regulation in today’s Federal Register implementing the Affordable Care Act’s (ACA) 60-day overpayment report and return provision ...
TAX REFORM The purpose of the current Angolan tax reform is to diversify sources of tax revenue (which up to now has been excessively dependent on oil), to modernise the Angolan tax system with a view to promoting greater tax justice and equity and also to increase the effectiveness and efficiency of the machinery of tax administration ...
In its judgment of 19 January 2012 (case no. 08332/11), the Southern Central Administrative Court, decided that INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (the national authority for medicines and healthcare products), is obliged to issue a certificate of subsidisation of the price of a medicine even when the person requesting the issue of the certificate was not the person who applied for the subsidy ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...
In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties ...
