In March 2022, a bill of law was introduced to amend the Sanitary Code by stating as a new requirement to carry out medical activities a civil liability insurance for damages committed during the professional practice ...
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
June 5, 2023 By: Joshua Robbins and Stephanie Shea While we wait for the U.S. Supreme Court to decide the fate of the Chevron doctrine governing courts’ deference to agencies’ interpretations of law, its recent decision in another case has flown under the radar. In Calcutt, III v. FDIC, 598 U.S ...
On June 1, 2023, China's Ministry of Science and Technology ("MOST") officially released the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which will come into effect on July 1, 2023 ...
On 16 March 2023, in Joined Cases C‑438/21P to C‑440/21P, the Court of Justice of the European Union (CJEU) interpreted the concept of a ‘global marketing authorisation’. It held that Article 6(1) of Directive 2001/83 (the Community Code) sets out exhaustively the line extensions for which the marketing authorisations (MAs) will fall under the same global MA as the initial MA ...
Through the sentence 67240 OF MARCH 1, 2023, the Third Section of the Council of State (hereinafter, the " CE ") resolved an appeal filed by a public entity against the first instance ruling handed down by the Administrative Court of Arauca, which acquitted an insurer of payment of the indemnity derived from compliance insurance, considering that the actions derived from the insurance contract against the insured entity had prescribed ...
The EU regulator has harmonized the maximum levels for tetrahydrocannabinol (THC) in hemp seeds throughout the Union within the food contaminants framework. This EU harmonization puts pressure on conservative national food laws such as the Belgian Royal Decree of 31 August 2021, which treats hemp seeds as a prohibited food.The situation in Belgium, however, is changing to better align it with EU law ...
On 29 March 2023, the Ministry of Economy and Finance (“MEF”), in cooperation with the Ministry of Commerce (“MOC”), issued a new regulation regarding the Official Fees for Issuance of Compliance Certificates for Commercial Advertisements on Goods and/or Services in Cambodia (“Prakas 167”) ...
Introduction An EU Regulation on the making available on the Union market as well as export from the Union of certain commodities and products associated with deforestation and forest degradation (“Deforestation Regulation”) was agreed upon by the EU legislators in December 2022. The European Parliament has now green-lighted the Provisional Agreement at this month’s plenary session ...
Ohio legislators are once again attempting to transform the state’s medical marijuana control program after a similar effort stalled out last year. Proponents of the proposed legislation, Senate Bill 9, seek to expand medical marijuana access to Ohioans and revamp the structure of the current program. The proposal would establish the Division of Marijuana Control (“DMC”) under the Department of Commerce ...
On the 2nd of February 2023, the European Insurance and Occupational Pensions Authority (hereinafter referred to as “EIOPA”) published a Supervisory Statement on the use of governance arrangements in third countries to perform functions or activities (hereinafter referred to as the “Statement”) ...
Americans have increasingly accepted meat and dairy alternatives as staples in their daily diets. For example, recent market research shows that two out of every five U.S. consumers plan to purchase plant-based meat products in 2023. The prevalence of these forms of alternative protein has set the stage for a semantic — and potentially paradigm-shifting — dispute over the very meaning of the terms "meat," "milk" and "dairy ...
On January 30, 2023, the Court of Appeal of Quebec rendered a decision in Commission scolaire De La Jonquière c. Intact Compagnie d?assurance.1 The key issues in this case are the potential for conflicts arising from liability insurance policies and the obligation to disclose documents where insurers? duty to defend conflicts with their duty to indemnify insureds ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
Introduction Mdeon, the legally recognised Belgian ethical platform for healthcare professionals and the pharmaceutical industry, announced several new ethics rules applying from 1 January 2023. The present blog post discusses their practical importance for the broader healthcare community, and particularly (i) several new ethic rules in light of the ascendant trend of virtual and hybrid scientific events, and (ii) new maximum hospitality amounts that can be offered to healthcare professionals ...
The MFSA commenced a consultation process on its proposed amendments to the Insurance Distribution Rules (hereinafter referred to as the “IDR”). The consultation process began on the 26th of January 2023 and closes on the 8th of March 2023 ...
In Case C-633/20 of the European Court of Justice (the ‘Court’) delivered on the 29th September 2022, the First Chamber of the Court produced a judgment (the ‘Judgment’) in response to a reference for a preliminary ruling concerning the definition of ‘insurance intermediary’ in the context of Directive 2016/97 (the ‘Insurance Distribution Directive’ or the ‘IDD’) and Directive 2002/92 (the ‘Insurance Mediatio
On October 24, 2022, the Department of Labor and Employment ("DOLE") issued Labor Advisory No. 20, series of 2022, which sets out the process for the issuance of the certification required from non-Philippine nationals intending to engage in business in the Philippines ...
On January 31, 2020, the Department of Labor and Employment (“DOLE”) issued Labor Advisory No. 6, series of 2020, which prescribes the period for: [a] the payment and/or the release of the final pay; and [b] the issuance of Certificate of Employment to employees who are terminated from their employment ...
In early 2022, the Autorité des marchés financiers (the AMF) conducted specific consultations on financial products offered on the Internet. Further to these consultations, the AMF published explanations on the Regulation respecting Alternative Distribution Methods (the RADM) in late December 2022 ...
The MFSA issued a Circular on the 22nd of December 2022 in which it proposed amendments to the Companies Act (Cell Companies carrying on business of Insurance) Regulations, Subsidiary Legislation 386.10 (“the PCC Regulations”). The PCC Regulations provide for the creation and regulation of cell companies ...