Under current Australian arrangements, the “Safeguard Mechanism” requires Australian facilities that produce over 100,000 tonnes of carbon annually (or an equivalent amount of greenhouse gases), known as “Safeguard Facilities”, to keep their net emissions below a baseline (or ceiling), which has been determined on a facility specific basis. To meet its international commitments to achieving net zero emissions by 2050, the Australian government has proposed changes to the operation of the Safeguard Mechanism with the effect of reducing carbon emissions over time. Those proposed changes have now been extended to secure the political support required to enable the passage of these legislative reforms through federal parliament.
Welcome to this Podcast called Legal myths and realities about family businesses. This space was created with the purpose of conducting a series of interviews dedicated to the main problems of Venezuelan Family Businesses, debunking myths and discussing their main legal problems in a globalized and increasingly sophisticated world. These conversations will be led by Jesús A. Villegas-Ruiz, Senior Associate of the Corporate and Compliance practice of Baker McKenzie Caracas. In the first chapter of this series of interviews, Jesús talks to Raúl Angulo, General Manager of TEALCA, C.A., about the problems of good corporate governance in decision-making in family businesses.
On 7 February the decrees of the Ministry of Health aimed at aligning the Italian legislation with Regulation EU 536/2014 on clinical trials were published in the Official Gazette.
On 30 January 2023, the European Commission published a document on the application of Regulation UE 536/2014 on clinical trials to provide sponsors and investigators with a quick guide on the rules and procedures established in the same Regulation with a view to facilitating its implementation.
With Decision No. 131, published on 4 January 2023, the Council of State ruled on the possibility for pharmaceutical companies to know in advance the data used by the Italian Medicines Agency for the calculation of the pharmaceutical payback.
On 3 February, the European Medicines Agency, the Heads of Medicines Agencies and the European Commission launched a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union.
On 19 January 2023, the Court of Justice of the European Union specified that Art. 2(2) of Directive 2001/83/EC, pursuant to which, in case of doubt on the classification of a product as a medicine or a medical device, the provisions on medicinal products shall apply, covers both “medicinal products by function” (i.e., substances exerting pharmacological, immunological or metabolic action) and “medicinal products by presentation” (i.e., substances presented as having properties for treating or preventing disease).
With the entry into force of Regulation (EU) 2019/1009 on fertilizer products, the regulatory framework for fertilizer products within the European Union has been updated. However, national regulations may continue to be used on an optional basis. This Regulation has extended the categories of fertilizers covered and it also provides for a number of obligations for manufacturers, importers and distributors of fertilizers, including the declaration of conformity and the CE marking. Finally, guidelines have also been established for the conformity assessment of these products.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine introduces three new sets of sanctions against persons contributing to the Russian aggression against Ukraine on 28 February 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
Baker McKenzie’s Sanctions Blog published the alert titled Ukraine imposes sectoral sanctions against all banks and financial services providers operating in Russia on 23 February 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.