INVIMA adopts measures aimed at efficiently facing the current health situation related to COVID-19, optimizing the processes that allow the commercialization of products necessary for the prevention of the virus and the evaluation of protocols to prevent it. 1. Declaration of products as Vital Unavailable. Due to the shortage of some supplies in general, the authority has declared that masks, antibacterial gel and disinfecting solutions as Vital Products Not Available ...
The Ministry of Health and Social Protection dictates measures tending to guarantee the prevention, diagnosis and treatment of Covid-19 The Ministry of Health and Social Protection has issued Decree 476 of 2020 by which it has decided to make the necessary changes for regulatory requirements to have flexibility in all proceedings related with Pharmaceutical, Phytotherapeutics, Medical Devices, Biomedical Equipment, In-Vitro Diagnostic Reagents, cosmetics and products of Domestic hygie
Businesses in need of capital may find themselves facing foreign investment regulatory hurdles. We discuss the challenges for businesses and the potential for regulatory relief. Australia's foreign investment regime applies very broadly and captures many transactions. As businesses consider how to respond to the demands of the current COVID-19 economic environment, they may be required to go through the Foreign Investment Review Board (FIRB) screening regime ...
Obligation of Czech employers to protect employees from coronavirusPursuant to Section 106 (1) of the Labour Code, an employee has the right be assured of occupational health and safety protection at work (hereinafter referred to as "OHS"), even during a pandemic.Regarding prevention, the provision in section 102 of the Labor Code remains paramount ...
State of Emergency Conditions What does "state of emergency" actually meanand what are the powers of the Government in the regard? Can someone claim damages incurred in relation to the state of emergency? State of Emergency With effect from 12 March 2020 at 2 pm, the Government of the Czech Republic (the “Government”) has declared astate of emergency for 30 daysfor the territory of the Czech Republic due to health threats related to the presence of coronavirus in the
Crisis measures issued after the announcement of the state of emergency List as of 14 March 2020 1. Temporary implementation of the protection of internal borders in the Czech Republic Underlying document: Government Declartion No. 197 from 12.3.2020 and extraordinary measures of the Ministry of the Interior dated 13.3.2020 Effectiveness from: 14.3.2020 od 0:00 hod. Effectivness until: 18.3 ...
An article establishing a procedure for the procurement of medical supplies was recently introduced. This new provision (Resolution No 53960) amended Resolution No 38941-2006-JD of February of 2006, which is the general procurement regulation for the Social Security Administration (CSS for its initials in Spanish) ...
FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
With the coronavirus outbreak, attention has been focused on the Defense Production Act of 1950 (“DPA”)[1], a statute dating back to the time of the Korean War, which authorizes the President in times of national emergency to: Make direct purchases and purchase commitments of critical supplies and services; Interrupt the normal flow of goods, even when under contract, by requiring U.S ...
The FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19 pandemic. The FDA acknowledges that companies, and the agency, itself, may be hit with workforce shortages during a pandemic at the same time that adverse event reporting for products deployed for the pandemic may increase ...
The U.S ...
The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...
To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead ...
The global health alert triggered by the spread of the new coronavirus known as SARS-CoV-2, which causes the disease COVID-19, is creating great challenges for companies. Governments around the world are tackling the situation by approving drastic measures to try to mitigate the effects of the health crisis first and the economic crisis second ...
I. Regulation In the context of the declaration of a State of Catastrophe, the National Customs Service (“NCS”) issued Exempt Resolution No. 1,179 dated March 18, 2020, by means of which the NCS adopted 13 measures to facilitate foreign and domestic trade operations electronically, and to protect the health of people involved in such operations ...
We have been in the UAE helping clients manage and survive crises for 45 years, and these are unprecedented times in our lives. We will have to work together to overcome the challenges brought about by the COVID-19 pandemic, and we at Afridi & Angell are ready to do our part. Until the end of March, we will offer free advice on legal issues affecting companies and employers as a result of the COVID-19 pandemic ...
Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services ...
As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services.Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health ...
As COVID-19 continues to spread, CMS has issued guidance to various healthcare providers, including, among others, home health agencies, nursing homes, and hospitals that are caring for the nation’s most at-risk patient populations.The guidance is intended to curb transmission and ensure healthcare providers have the information and resources necessary to respond to patient needs ...
At LEĜA we are monitoring the measures that are taken to face the crisis generated by COVID-19 and we will be sending updates to our reports and comments divided by practice areas and industry so that you can easily find the information that is relevant to you. Please note that it is our policy to report announced measures only when they are translated into acts published in the Official Gazette ...
In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been applied to a variety of uses, including paternity determinations and the discovery of genetic ancestors and relatives ...
The Centers for Medicare & Medicaid Services (CMS) announced during a March 19, 2020 teleconference for physicians and teaching hospitals that it does not have the authority to postpone the statutory timeline for the Physician Payments Sunshine Act (Sunshine Act) ...
