Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:the Sale of Drugs Act 1952 (SODA 1952);the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);the Dangerous Drugs Act 1952 (DDA 1952);the Poisons Act 1952 (PA 1952);the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); andthe Medical Device Act 2012 (MDA 2012) ...
A case of forced resignation does not automatically amount to an unfair dismissal. In the recent decision of Mohd Rizam bin Ibrahim v Prince Court Medical Centre Sdn Bhd dated 5 June 2020 [Award 716 of 2020], the Industrial Court ruled that although the employee was forced to resign, the same was with just cause and excuse ...
This 12th edition of Unprecedented, our weekly update on COVID-19-related litigation brings new developments in labor and employment cases, consumer protection cases, and civil rights litigation. Price gouging and fraud for personal protective equipment (particularly N95 masks) remain major focuses, with manufacturers, retailers, and governments all taking action ...
Key Points Title VII prohibits discrimination based on sexual orientation and gender identity. The holding does not change currently-existing legal obligations for California employers as discrimination based on sexual orientation and gender identity is prohibited under the FEHA. California employers should ensure they are complying with FEHA’s posting and training requirements. On Monday, June 15, 2020, the U.S. Supreme Court published a long-awaited opinion, Bostock v ...
Key Points The third Golden Door iteration resulted in a common refrain: San Diego County has not yet reached the high bar for greenhouse gas mitigation (GHG) measures under CEQA Enforceability is a significant component of a CEQA compliant GHG mitigation measure In a nod to the recently approved Newhall Ranch plan, the Court of Appeal outlined the contours of acceptable carbon offset programs, both within and outside California In Golden Door Properties, LLC, v ...
Vietnam, a country of 97 million people, has been widely recognized for its successful handling of the novel coronavirus outbreak. On January 27, as the country celebrated the Lunar New Year holiday, Prime Minister Nguyen Xuan Phuc declared war on the coronavirus, having said "fighting this epidemic is like fighting the enemy". The Prime Minister and his cabinet acted expediently in controlling the spread of the virus ...
A recent decision from the Ninth Circuit Court of Appeals is likely to have a significant impact on both copyright infringement matters and copyright registration practices in the Ninth Circuit, if not nationwide. The case, Unicolors v. H&M, 2020 U.S. App. LEXIS U.S. App. LEXIS 17097 (9th Cir. May 29, 2020) involved claims for copyright infringement brought by Unicolors, Inc. (“Unicolors”) against retailer H&M Hennes & Mauritz, L.P. (“H&M”) ...
In the recent case of MillChris Developments Ltd v Fiona Selski Waters [2020] 4 WLUK 45, before England’s Technology and Construction Court, a party to an adjudication applied for an injunction to prohibit the adjudication continuing on the grounds that due to COVID-19 it had insufficient time to comply with the adjudicator’s directions and would be unable to attend a site visit. The Court declined to make the injunction and ordered that the adjudication proceed ...
MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
This 11th edition of Unprecedented, our weekly update on COVID-19-related litigation, identifies news reports placing the number of COVID-19 filings at around 2,700, with insurance coverage disputes former the single largest category. And so unsurprisingly, one of the matters we report this week is the dispute over whether those insurance coverage disputes should be consolidated into multi-district litigation ...
In a highly anticipated decision, the U.S. Supreme Court held Title VII of the federal Civil Rights Act protects LGBTQ employees from being fired because of their sexual orientation or gender identity. The opinion, released on June 15, 2020, was a consolidation of three federal appellate court decisions—Bostock v. Clayton County; Altitude Express v. Zarda; and R.G. & G.R. Harris Funeral Homes v. Equal Employment Opportunity Commission ...
1. Introduction Pursuant to Law no. 40 of 5 June 2020, published in the Official Gazzette no. 143 of 6 June 2020 (the “Conversion Law”), Law Decree no. 23 of 8 April 2020 (the “Liquidity Decree”) was converted into law with amendments. Below is a summary of the key amendments made to Chapter II (Urgent Provisions to Ensure Going Concern) by the Conversion Law. 2 ...
The unstable economic situation connected with the COVID-19 pandemic is also impacting the insurance industry. Dependent on global phenomena and trends, the insurance market will soon have to face anew economic reality, develop appropriate solutions for clients, and prepare to defend against claims ...
This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as aproving ground for the regulatory approach to oversight of algorithms. The immediate inspiration for writing this text was asolution from the company StethoMe presented at the DemoDay organised by the MIT Enterprise Forum CEE ...
Preparation of financial statements and corporate income tax, recommencement of time periods, remote trials, gradual return to workplaces, insolvency proceedings and compliance with criminal law In a new edition of our COVID-19 Special Newsletter, we examine the key new legislation approved over the past two weeks in all areas of business law ...
On April 6, 2020, Law No. 21,227 entered into effect, authorizing access to the benefits of the unemployment insurance in the context of the sanitary crisis caused by Covid-19 (hereinafter, the “Law on Employment Protection” or “LEP”). In order to improve the practical application and implementation of the aforementioned act, on June 1, 2020, Law No ...
This tenth edition of Unprecedented, our weekly update on COVID-19-related litigation, finds us reporting fewer shutdown-related cases than in previous weeks, suggesting that these cases are winding down as the country opens back up. By contrast, our prediction that workers' compensation and personal injury cases would begin to pick up with reopening appears to have borne out, with this week bringing the first reported “household exposure” claim ...
The Commission for the Financial Market (“ CMF ”), on May 28, 2020, has issued the Official Letter No. 22,260 (the “ Official Letter ”) in response to the pronouncement request sent by the Treasury Minister of the Chilean Government, Mr Ignacio Briones Rojas, to clarify the scope of the enforcement and the effects of the new article 30 of Law No. 21,227, which empowers the access to the unemployment insurance benefits provided in Law No ...
Do I have a COVID-19 business interruption claim? Particularly if you operate in the leisure, retail or hospitality sectors, your business has likely suffered significant financial losses from the disruption caused by COVID-19. In trying to alleviate the impact of those losses, you might have identified that your business’s insurance policy offered cover for ‘business interruption’ (or ‘BI’) ...
As clients and counsel wrestle with the changing dynamics within litigation and trial work, Bradley has assembled trial lawyers with experience from hundreds of trials and a jury consultant of national standing to present on what is happening in courts across the country and how it is impacting the judicial system as we know it ...
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
Key Points As the State begins to open back up, COVID-19 employment related litigation also begins. Several trends have emerged. On an individual and class-wide basis, Plaintiffs cite disability discrimination, emotional distress, retaliation, reimbursement, public nuisance and WARN Act claims, among others ...
Following the World Health Organization’s announcement of a public health emergency caused by COVID-19 and its declaration ofan international pandemic, the President of the Republic declared a state of emergency on 18 March and this lasted until 2 May. On 30April, theGovernment declared a situation of calamity and this was renewed on 15May and 29 May ...
This ninth edition of Unprecedented, our weekly update on COVID-19-related litigation, continues to be dominated by shutdown challenges and workplace injury and wrongful death claims. But as governments discuss contact tracing as a way to control COVID-19’s spread, a data breach lawsuit against Deloitte illustrates the risks associated with creating the systems and collecting the necessary information ...
Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them ...
