Join Baker McKenzie regulatory and enforcement practitioners as we navigate this uncertain time and work together through the challenges ahead. We offer practical advice and real-time analysis of the changing landscape across the United States, Europe and Asia. Webinar Series: The New Framework for Investment Adviser Marketing In this 4-part…
In brief This is an update of the draft regulations in Vietnam affecting e-commerce platforms (the scope of…
In brief Wildu du Plessis, Head of Africa for Baker McKenzie, quotes from a recent Baker McKenzie report…
Even though the term “cosmeceutical” is not new from the global market perspective, such products are considered relatively new from the Thai legal perspective. The Thai Food and Drug Administration (FDA) has been working on finding a new product category for herbal-based/herbal-related products with health claims for quite some time and has recently introduced the Herbal Product Act B.E. 2562 (HPA). The HPA will, generally speaking, regulate and manage the herbal drugs and herbal products which cosmeceutical is part of.
After having rejected initially any possibility in this regard, the Federal Ministry of Health (“MoH”) issued a Decree, published in the Official Gazette on 25 January 20211 establishing the conditions under which the local (State) governments and the private sector, can participate in the National Vaccination Program for COVID-19. Although it does not eliminate many uncertainties, it opens certain possibilities of action.
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The increase in legal and regulatory measures arising out of COVID-19 is truly proportional to the growth of the pandemic itself. Although the measures affect all industries, many of these have direct implications and relevance on the healthcare and life sciences sectors. While some industries and services are forced to shut down, companies in the healthcare and life sciences ambit are pushed to work even harder, innovate faster, collaborate and be resilient at an unprecedented pace.
Such measures aim to assure supplies of medicines and medical devices at home as well as to accelerate R&D through incentives. While the pandemic has put some clinical trials in jeopardy, many jurisdictions are now passing special regulations to protect patients while ensuring that ongoing trials can continue. Industry peers are “sharing” IP, be it through compulsory licensing or forced collaborative manufacturing arrangements. Many countries have adopted specific measures to broaden access to telemedicine, a trend expected to survive and grow well beyond the pandemic.
In a press release dated December 30, 2020, the AIFA (Agenzia Italiana del Farmaco) clarified that, in view of the current health emergency, applications for placing on the Italian market COVID-19 vaccines are subject to the emergency procedure for Batch Release provided for by the AIFA.
With judgment No. 8126 of 17 December 2020, the Council of State ruled on the legitimacy of an agreement between a public research institution and a private company, entered into without a public call for tenders, whereby the former received COVID-19 serological and molecular tests prototypes to be used in the context of its research activities and undertook to provide the company with the relevant results so that the latter could use them to obtain the CE mark.
With decision No. 28446/2020, the Italian Antitrust Authority sanctioned with a fine of 550,000 Euros a company engaged in the on-line sale of masks without the CE mark for unfair commercial practices.