Q&A procedures before the Public Health Institute (ISP) May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
Zoom, the social platform which has become nearly ubiquitous in the past few weeks, has unintentionally introduced the world to a new term: “Zoom Bombing." Millions of people are struggling to maintain some semblance of normalcy as they continue to engage in personal and business interactions while simultaneously practicing social distancing during the COVID-19 pandemic ...
Through External Circular No. 001 of March 23, 2020, the Superintendence of Industry and Commerce (SIC) made clear that mobile phone operators and private entities in general have legal grounds to provide to the National Planning Department (DNP), as well as to public entities that so require it, personal data that is necessary to address, prevent, treat and/or control the spread of COVID-19 and mitigate its effects ...
The Ministry of the Interior issued Communication 015 of 2020, through which the Ministry set made recommendations for the prevention, containment, and mitigation of the coronavirus COVID19 in ethnic groups: indigenous peoples, the NARP communities (Black, Afro-Colombian, Raizales, and Palenqueras) and the PROM people ...
In the wake of the COVID-19 outbreak, the business community is faced with unprecedented threats to their cyber-infrastructure and data. Sensitive data, in particular, will be vulnerable to security breaches as a result of reduced human power under emergency legislation. Moreover, criminal hackers will be looking to capitalize on such vulnerabilities at a time like this ...
In some areas, intellectual property will experience a period of slowdown in activity, at least in the near future. We look at this in more detail below. However, this does not mean mandatory registration of industrial property will come to a halt because, with many bodies, including the Portuguese INPI (National Institute of Industrial Property), registration is done online ...
As if businesses did not have enough to worry about during this COVID-19 pandemic, it’s times like these when cybersecurity risk is at its peak. Distracted employees may be psychologically vulnerable to attack, and shifting quickly and unexpectedly to a remote workforce can create technology and control risks. It’s a perfect storm for cyber risk ...
Superintendence of Environment orders the suspension of terms and enforces virtual channels in the context of Covid-19 The Superintendence of Environment has suspended all of sanctioning proceedings and implemented virtual channels to receive consultations, complaints and replace its reception office ...
Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation ...
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 ...
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) ...
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 COVID-19 pandemic has disrupted every sector of the economy in multiple ways. For businesses whose operations are subject to environmental requirements, including waste management, storage, and disposal laws, these coronavirus-related disruptions may impact a facility’s ability to comply with mandatory reporting and submission deadlines or waste storage time limits ...
Data protection and privacy laws are relevant to current responses aimed at preventing the spread of the coronavirus. An important response to limit the spread of the infection is the practice of identifying and monitoring anyone who may have been in contact with an infected person ...
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 ...
Many organizations are these days in a phase of reorganizing their operations and establishing alternative solutions to ensure continued business work capacity. Meanwhile numerous hackers and other cyber criminals around the world are mobilizing themselves to take advantage of the extraordinary situation. All business should therefore be aware of a significant increase of cyber risk in relation to the current corona crisis ...
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 ...
