Welcome to our blog dedicated to Life Sciences. We report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector. We focus on (bio)pharmaceuticals and medical technologies, and also cover food and beverages, cosmetics and other healthcare products.

The cannabis market: helping investors navigate the UK regulatory regime

Matthew Townsend

Last year the global legal cannabis market was estimated to be worth USD12 billion but it is tipped to rise to over USD166 billion by 2025. Liberalisation of the legal framework for cannabis is a significant driver for this growth. Since 1 November 2018, the UK has joined the ranks of over 30 countries legalising Read More

Italy launches urgent tender for the supply of 400 kg of medical cannabis: New opportunities for cannabis producers

Roberta Errico

For the second time, the Italian Ministry of Defence has launched an open tender for an urgent need of cannabis for therapeutic purposes by the Florence Pharmaceutical Chemical Plant. The estimated reference price of the tender is EUR 1,520,000 (net of VAT) for 400 kg, which represents an average of EUR 3.8 per gram. This Read More

Belgium amends procedure for notification of implants and certain invasive medical devices

Kaat Van Delm

On 1 June 2019, a new Royal Decree (dated 7 April 2019) altering the notification procedure for implants and certain invasive medical devices for long-term use entered into force. Previously, the Belgian Sickness and Invalidity Institute (RIZIV/INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical Read More

Dutch medicines regulator updates policy on how to carve out patented indications

Lars Braams

On 8 May 2019, the Dutch Medicines Agency (CBG/MEB) published a revised policy on generic manufacturers’ ability to carve out patented indications from their product information (that is, leaflet and summary of product characteristics). This new policy is a direct result of the CJEU’s preliminary ruling in Staat der Nederlanden v Warner-Lambert Company LLC (Case Read More

Medical cannabis in France: Latest state of play

Eveline Van Keymeulen

Following the penultimate meeting of the specialised committee on cannabis (CSST) established by the French National Agency of Medicine and Health Products Safety (ANSM) (see our previous blog posts “French ANSM temporary scientific committee pursues activities on modalities of medical cannabis availability” and “French ANSM recommends medical use of cannabis under certain conditions“), the French Senate Read More