Since 2013, the National Medical Products Administration ("NMPA")Center for Drug Evaluation("CDE")has been releasing a Drug Review Annual Report ("Report")each year, which summarizes its work on drug review of the previous year ...
How can an employment disciplinary investigation findings determine fitness and propriety? Senior Managers & Certification Regime (SM&CR) firms are under a duty to consider fitness and propriety on an ongoing basis ...
Direct marketing by email is a keystone for many businesses. It can be efficient and effective: but are you confident you are getting it right? Getting it wrong can cost customer goodwill and see the regulator knocking at the door. On 17 October the UK data regulator, the Information Commissioner’s Office (ICO), issued new guidance on electronic mail for direct marketing purposes which should be helpful for companies trying to do the right thing ...
The Indonesian Minister of Health has issued Minister of Health Regulation No. 24 of 2022 on Medical Records (“MOH 24/2022”), under which the MOH requires all healthcare facilities to keep electronic medical records. MOH 24/2022 allows, among other things, cooperation between a healthcare facility and a third-party electronic organizer and covers who may have access to electronic medical records ...
A breakdown of the ICO’s recent guidance on how to comply with the UK’s data protection regime when making live marketing calls. The ambiguous lyrics from this popular song have left me confused ...
On October 26, 2022, the National Medical Products Administration ("NMPA") issued the newly revised Measures for the Administration of Drug Recalls ("the 2022 Measures") that has just been formally adopted. The former Measures for the Administration of Drug Recalls ("the 2007 Measures") was issued and implemented on December 10, 2007 ...
1. Introduction Transmission services used in the provision of M2M services are growing in importance. As a result, in May 2019 ANACOM (the Portuguese communications regulatory authority) launched a public consultation1 to collect input on the possible creation of a specific range in the national numbering plan (plano nacional de numeração - PNN) to accommodate these services ...
The SEC Division of Examinations issued a Risk Alert on September 19, 2022 announcing examination initiatives relating to Advisers Act Rule 206(4)-1 – the “Marketing Rule.” The compliance date for the Marketing Rule is November 4, 2022. Any advertisements distributed by investment advisers on or after that date are subject to the requirements of the Marketing Rule. This alert outlines areas that will be reviewed during examinations ...
October is Breast Cancer Awareness Month, an annual campaign to raise awareness about the impact of breast cancer and to raise funds for research into its cause, prevention, diagnosis, treatment and cure. The firm held an event last week at its offices with staff in order to raise awareness about breast cancer and to raise funds for the cause. The firm is once again making a contribution to the Action for Breast Cancer Foundation ...
On 13 October 2022, Shoosmiths hosted a webinar on the UK Covid-19 Inquiry (the ‘Inquiry’). The webinar took a closer look at the structure and progress of the Inquiry, alongside the commercial and legal considerations that any potential witness or party should be aware of, including the role of a Core Participant (‘CP’). The webinar was hosted by Paul Eccles (Partner) and included talks by Alex Friston (Associate) and Charles Arrand (Partner) ...
In February of 2022, during his State of the Union Address, President Biden announced an action plan to improve the safety and quality of care in the nation’s nursing homes.[i] On October 21, 2022, Centers for Medicare and Medicaid Services (CMS) announced new requirements to help with oversight of facilities selected to the Special Focus Facilities (SFF) Program ...
On the occasion of Breast Cancer Awareness Month 2022, our firm organized a photo-taking session on Friday, October 21 at 3 pm. This session is a part of a global effort to raise awareness about breast cancer, one of the world’s most prevalent types of cancer. Often times, the disease has been overlooked by males. However, breast cancer can affect both men and women ...
On December 7, 2021, in Georgia v. Biden, Case No. 1:21-cv-163, a federal district court judge in the U.S. District Court for the Southern District of Georgia issued a preliminary injunction enjoining enforcement of the COVID-19 vaccine mandate for federal contractors and subcontractors in all covered contracts in any state or territory of the United States. This injunction was nationwide applied to all federal contractors ...
With many clients moving towards cloud computing models and looking to outsource certain components of their business to cloud service providers, we often get asked to advise on the legal risks associated with opting for a single-cloud strategy versus a multi-cloud strategy. A company is reliant on one cloud vendor to provide all elements of the cloud solution if it opts for a single-cloud strategy ...
On 25 August 2022, the Minister of Communications and Digital Technologies published the Films and Publications Amendment Regulations, 2022, (“Regulations”) which came into effect on 2 September 2022. The Regulations provide clarity and guidelines regarding the implementation of the Films and Publications Amendment Act, 2019 that came into force on 1 March 2022 ...
In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs (“EPSCO”) Council, health ministers expressed their concerns regarding the legislative transition to Regulation (EU) No 2017/745 of the European Parliament and of the European Council of 5 April 2017 on medical devices (“MDR”) and to Regulation 2017/746 of the European Parliament and of the European Council of 5 April 2017 on in vitro diagnostic medical devi
October 12, 2022 By: Michael Flynn On September 27, 2022, the Consumer Financial Protection Bureau (CFPB) issued a Request for Information Regarding Mortgage Refinances and Forbearances. The Request indicates that the CFPB is considering making the COVID emergency relief foreclosure/loss mitigation requirements a permanent requirement for mortgage lenders and servicers when dealing with temporarily distressed borrowers ...
Most people know that Facebook is now Meta, following a well-publicised rebrand in 2021. According to an article that appeared in the publication IP Planet: “the main goal was for this name to fit better with future developments of the company, and in particular with the emergence of the metaverse as a new virtual world.” Image source: Unsplash We reported back in 2021 on the emergence of the Metaverse ...
During the COVID-19 pandemic, questions about employee health-privacy-related symptoms, testing, and vaccination became prevalent in discussions about the workplace at all levels—from “the water cooler” to national news ...
Key Points AB 890 gave Nurse Practitioners who meet certain requirements authority to practice more independently. The bill created two categories of Nurse Practitioner—one that may perform delineated functions without the use of standardized procedures in certain clinical settings where physicians and surgeons practice and another that may perform these functions and more outside of such clinical settings ...
On September 23, Kudun and Partners were invited by TrustLaw, the charitable arm of Thomson Reuters, to be the legal experts in their Legal Health Check Workshop. The core objective of the event was to raise awareness of how law firms, like Kudun and Partners, can work with TrustLaw to provide pro bono legal services to NGOs, Civil Society Organizations (CSOs) and social enterprises (SEs). Chai Lertvittayachaikul and Emi Rowse (Igusa), partners of Kudun and Partners, presented at the event ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...
A recent decision by the UK’s Data Protection Authority, the ICO, throws some interesting light on the regulatory mood around enforcement of the rules governing how businesses can use their customer lists for marketing emails. It’s worth thinking about how easily an over-enthusiastic approach can go wrong. On 6 September 2022, Halfords were fined £30,000 by the ICO for sending around half a million unsolicited marketing emails ...
