Medical devices

EMA advises study sponsors to amend Informed Consent Forms

Nieke Vanavermaete

Consent Forms (ICF) to include an explicit reference as to the possibility that EU inspectors would have access to medical records and personal data of clinical trial participants. In February 2021, the European Medicines Agency updated its guidance in the form of questions and answers (Q&As) on Good Clinical Practice (GCP). GCP is a code Read More

EU – Parallel trade in the life sciences sector – Q&A

Francesca Miotto

On Tuesday, 26 January 2021, Allen&Overy (Belgium) LLP hosted a webinar on the key developments in parallel trade of pharmaceuticals in 2020. In this blog post, we discuss a few key topics and questions raised by the webinar’s participants.­ How will the competition law framework apply post-Brexit?­ Post-Brexit, companies active in the UK and the Read More

French Interministerial Mission on Drugs (MILDECA) reacts to CJEU Kanavape judgment

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On 24 November 2020, following the decision of the European Court of Justice (CJEU) in the Kanavape case, the French Interministerial Mission for the Fight against Drugs and Addictive Behaviours (MILDECA) published an update on the legal status of cannabidiol (CBD) in France. The judgment, which was rendered on 19 November 2020, confirmed that CBD Read More

CJEU landmark ruling confirms that CBD is not a narcotic drug and that member states may not prohibit its marketing

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Today, the Court of Justice of the European Union (CJEU) delivered its long-awaited decision in Case C-663/18 (Kanavape) ruling that a member state may not ban the marketing of cannabidiol (CBD) extracted from the Cannabis sativa plant in its entirety. In today’s judgment, the Court finds that EU law, in particular the provisions on the Read More

Covid-19 coronavirus: patent database observations

Lars Braams

As per 8 September 2020, 143 search results containing the words “Covid 19” in the title, claims or the abstract of a patent show up in the international patent database Espacenet. Over the past weeks, this number grows with about 15 new results each week. While the race for a vaccine covers the headlines around Read More