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In this issue: Energy Environment Life sciences TMT LexTalk®EU Law: a Lexis®Nexis community Daily and weekly news alerts Trackers New and updated content Energy Consultations open on FuelEU Maritime verification and monitoring requirements The European Commission has opened three consultations on the FuelEU Maritime Regulation, intended to advance the decarbonisation of the shipping sector. The first examines the technical specifications for verification activities that will apply to shipping companies’ emissions. The second presents a template for the plans that companies must submit, explaining how their ships will be verified and how their emissions will be monitored. The third details the methods and criteria for accrediting ‘verifiers’ who will oversee compliance with the monitoring plan and the verification of FuelEU reports and documentation. The deadline for responses is 24 April 2024. See: LNB News 28/03/2024 80. Environment ECHA announces project to check poison centre notifications ECHA has indicated that its Enforcement Forum has...
In this issue: Regulatory framework for medicinal products Commercialisation Research and development Competition in life sciences LexTalk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Regulatory framework for medicinal products Court of Justice finds that scientific experts’ conflicts of interest meant refusal of marketing authorisation was unlawful On 14 March 2024, the Court of Justice handed down its ruling on the appeal brought by Debrégeas et associés Pharma SAS (D&A Pharma) against the earlier judgment of the General Court of the EU (the General Court), which had dismissed its action challenging the European Commission’s refusal to grant a conditional marketing authorisation (CMA) for D&A Pharma’s medicine, Hopveus (sodium oxybate). The Court of Justice set aside the General Court’s judgment and quashed the Commission’s decision, concluding that some of the scientific experts engaged by the European Medicines Agency (EMA) to advise on...