Understanding the intricate regulatory frameworks for pharmaceuticals, biotechnology, and medical devices within the European Union can be challenging. This topic offers practical insights and tailored guidance for legal professionals, ensuring compliance with EU directives and regulations while fostering innovation and safeguarding public health. Explore the latest developments, case law, and strategic considerations crucial for mastering the intricacies of life sciences law in the EU.
The European Ombudsman has closed an inquiry into energy consumption reporting for general-purpose artificial intelligence (AI) models and encouraged...
The European Commission has selected 46 new Strategic Projects under the Critical Raw Materials Act (CRMA) across 16 Member States after a second call...
The European Medicines Agency (EMA) has announced that the Accelerating Clinical Trials in the EU (ACT EU) advice pilot will become a permanent...
The European Commission has adopted uniform conditions for operating rules (UCOL) for poultry and pig farms under Directive 2010/75/EU (the Industrial...
HarmonisationDefinition of harmonisationHarmonisation, also known as standardisation or approximation, refers to the determination of EU-wide legally...
Indirect effect of EU lawWhat is indirect effect of EU law?The doctrine of indirect effect, or consistent interpretation, is a duty that national...
The EU Commercial Agents DirectiveThis Practice Note considers Council Directive 86/653/EEC (OJ L 382/17), the EU Commercial Agents Directive. It...
Infringement proceedings against EU Member StatesUnder Article 17(1) of the Treaty on European Union (TEU), one of the European Commission’s core...
What is the difference between an appeal and a review?What is an appeal?An appeal in insolvency proceedings is no different to an appeal in normal litigation. An appeal will be allowed only if the appeal court is satisfied that the decision of the lower court was 'wrong' or 'unjust because of a
If a beneficiary signs a deed of disclaimer of their share of an estate and the estate pays their legal fees, will that count as a PET against their estate?A disclaimer is the refusal of a gift prior to acceptance. The refusal of the gift must take place before the beneficiary accepts any benefit
Strike out—making an application to strike out a statement of caseA strike out order can be made either following an application by the parties or on the court's own initiative. This Practice Note deals with the scenario of the order being made following a party's application.Making an application
Template for regulatory references given by SMCR firms and disclosure requirements[Insert addressee details]Dear [insert name][It is our understanding that [insert name of prospective employee] [was an employee of yours between the dates of [insert dates as appropriate] OR is a current employee of
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