The National Drug Agency Department of the Institute of Public Health, through exempt resolution No. 01746 of September 6, 2021, approved a guide to provide guidelines regarding the technological transfer of pharmaceutical production processes, necessary to obtain the authorization of a new manufacturer of a medicament, maintaining the previously authorized one ...
Arbitration Rules 2021The Asian International Arbitration Centre (“AIAC”) launched its latest edition of the AIAC Arbitration Rules (“AIAC Rules”) on 1 August 2021. The AIAC Arbitration Rules 2021 (“2021 Rules”) streamline proceedings and embrace the needs of a fast evolving disputes climate ...
Are donations of counterfeit goods to charities socially acceptable? - Despite calls for seized counterfeit goods to be donated to charity, a number of conditions should be met in order to protect both IP rights holders and those receiving the goods Nobody would dispute that in today’s world, the social and environmental impacts of our actions must be taken into consideration whenever we make a decision ...
In a ruling of 19 April 2022, the Belgian Supreme Court decided that an A1-certificate issued by a competent foreign authority to a posted worker does not exclude compliance with the DIMONA obligation. Does this mean that all foreign employers posting employees to Belgium must now file both a LIMOSA and a DIMONA declaration? This article sheds some light on the scope of the Supreme Court’s decision and the particular context in which it was taken ...
We previously reported that on March 30, 2017, Ohio Gov. John Kasich and the executive directors of Ohio’s health care licensing agencies announced new standards for prescribing opiates for acute pain ...
FDA Announces Public Meeting for Responsible Innovation in Dietary Supplements Industry Recently, the Federal Food and Drug Administration (FDA) announced it will hold a full-day public meeting to discuss strategies for responsible innovation in the dietary supplement industry. The meeting will be held May 16, 2019, from 8:30 a.m. EST to 4 p.m. EST at the FDA Center for Food Safety and Applied Nutrition, Wiley Auditorium, located at 5001 Campus Dr., College Park, MD 20740 ...
Some West Virginia businesses have implemented COVID-19 vaccine mandates for employees. While the West Virginia COVID-19 Jobs Protection Act (W. Va. Code § 55-19-1 through § 55-19-9) protects people, businesses, and entities from some COVID-19 related claims, the Act does not address whether employees who suffer an injury from a COVID-19 vaccine mandated by their employers may bring a workers' compensation claim ...
It has been four months since the changes to 42 CFR Part 2, the confidentiality regulations that apply to all substance abuse treatment records, became effective. Ensure your policies and forms have been updated. The finalized changes to 42 CFR Part 2 by the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), took affect March 21, 2017 ...
On January 1, 2023, the Ohio Board of Nursing joined the multi-state Nurse Licensure Compact (“NLC”), allowing nurses who hold an Ohio nursing license to apply for a multi-state license. Ohio has joined at least 37 other states that participate in the multi-state license ...
The Arendt Weekly Update is a newsletter designed to give you the insight you need without overloading your mailbox. It lists the latest news, topical webinars, training courses and more ...
Key Points U.S. Army Corps of Engineers finalized a rule renewing nationwide permits under the Clean Water Act for projects involving discharges of dredge or fill material to jurisdictional waters. The Army Corps also issued new nationwide permits, such as for water reclamation and reuse facilities and for activities involving water, stormwater, and wastewater utility lines. These new nationwide permits create opportunities to expedite permitting for certain infrastructure projects ...
By virtue of the Rules of the High Court (Amendment) Rules 2020 and Rules of the District Court (Amendment) Rules 2020, the Arrangement for Mutual Service of Judicial Documents in Civil and Commercial Cases between the Hong Kong Special Administrative Region and the Macao Special Administrative Region (Arrangement) came into force on 1 August 2020. Under the Arrangement the Hong Kong and Macao courts may entrust each other with the service of judicial documents ...
An official channel has been established between Hong Kong and Macao, with effect from 1 August 2020, whereby the Courts of Hong Kong and Macao may entrust each other with the service of judicial documents in civil and commercial proceedings. The Rules of High Court and Rules of District Court have been amended to give effect to the Arrangement ...
BAG, ruling dated 18 March 2020, 5 AZR 36/19 FACTS OF THE CASE The plaintiff is employed as a service technician in the field service. The defendant company is bound by the collective bargaining agreements of the wholesale and foreign trade of Lower Saxony due to its membership in the employers' association. The plaintiff drives from his home to the first customer every working day and returns there from the last customer ...
Following the submission of the first Draft of the Artificial Intelligence Act (”AI Act”) on April 21, 2021 by the European Commission for regulating artificial intelligence (AI) (we reported here), the European Parliament also published its final position on June 14, 2023. Thus, the next step now is the trilogue between the Parliament, the Council and the Commission ...
In its flagship report entitled Global Economic Prospects released in January, the World Bank observed: “The Philippines is particularly weak with regard to transport and trade-related infrastructure … with particularly low rankings for the quality of its seaports and airports. About one-quarter of the population remains without electricity.” Yet growth in the Philippines is projected to accelerate to 6 ...
This article has been published in PLI Chronicle. The market for consumer products derived from cannabis and its components, including cannabidiol (CBD), is exploding. U.S. sales of CBD products is expected to exceed $20 billion by 2024, up from just $1.9 billion in 2018. TheCBD market is expected to develop across diverse industries such as cosmetics and skin care, health products, food and beverage, pet products, and pharmaceuticals ...
The SEC’s Division of Enforcement recently issued itsannual reportdetailing enforcement activities, statistics, and changes made in the past fiscal year (“FY 2018”). The report discusses several significant developments in the SEC enforcement landscape, including the creation of new task forces, first-of-their kind enforcement actions, and the impact of the Supreme Court’s decision inKokesh v. SEC, 137 S. Ct. 1635 (2017) ...
Introduction The sphere of asset tracing and recovery, particularly the extent of tools available around the world, is rightly attracting more attention in cross-border fraud and investigations. This includes projects at the international level, such as UNCITRAL's ongoing efforts (for which the author acts as an expert), as well as attention being given in national legislatures around the world ...
On 1 April 2022, the Qualifying Asset Holding Companies (“QAHC”) regime, the latest innovation in the UK’s corporate tax landscape, came into effect for UK tax resident companies. Meanwhile in the EU, the European Commission has announced it will be introducing the anti tax-avoidance directive (“ATAD 3”) aimed at EU resident holding companies claiming benefits under double tax treaties and due to come into effect on 1 January 2024 ...
On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings ...
Don Stuart, a partner in Waller’s Tax Practice Group and current Chair of the Tax and Finance Practice Group of the American Health Lawyers Association (AHLA), and Kim Looney, partner in the firm’s Healthcare Compliance and Operations group, are authors on two chapters in the AHLA’s new publication The ACO Handbook: A Guide to Accountable Care Organizations, Second Edition ...
The concern expressed in our last Australian Legal Update about the possibility of Australia following most of the rest of the developed world into recession fortunately proved unfounded. Australia has been a notable exception to the experience of many other countries in this respect ...
In the words of its own Attorney-General, Australia's privacy laws were “out of date and not fit-for-purpose”. After recent amendments, they now stand to contain one of the world’s toughest data breach penalty regimes. So, what has changed? Fines The Privacy Legislation Amendment (Enforcement and Other Measures) Bill 2022 (the “Bill”) received Royal Assent on 12 December 2022 ...
In Roadshow Films Pty Ltd v iiNet Limited (No 3), Justice Cowdroy considered whether iiNet Limited (iiNet), the third largest internet service provider (ISP) in Australia, should be held liable for infringement of copyright by its subscribers, on the basis that iiNet had authorised those infringements.Proceedings were brought against iiNet by 34 applicants comprising many of the major film studios and their exclusive licensees in Australia (applicants) ...
