Pharmaceuticals
Edwards Lifesciences v Boston Scientific: Decision of UK Court of 24th May 2018
14 June 2018 - Posted by: Marjan Noor
The issue of whether public health policy considerations can prevent the grant of a final injunction is a live one as the number of disputes in the biologics field increases. In this decision of the UK High Court of Justice, public health considerations led to the stay of the injunction and also its qualification for › Read More
Dutch Parliament adopts bill to amend Medicines Act
11 June 2018 - Posted by: Iradj Nazaryar
At the end of April 2018, the Dutch House of Representatives adopted a legislative proposal to amend the Dutch Medicines Act (DMA). The Bill increases the maximum statutory amount for administrative fines for violations of the DMA, currently set at EUR 450,000, to the amount determined for the sixth category in Article 23 of the › Read More
06 June 2018 - Posted by: Eveline Van Keymeulen
Yesterday, the French National Agency for Medicines and Health Products Safety (ANSM) provided some clarifications with respect to its Recommendations for applicants and holders of marketing authorisations on the labelling and packaging of human medicinal products dispensed in solid oral form and its Recommendations on the choice of medicinal product names (dated February 2018) (see our › Read More
European Commission adopts revised definition of “similar medicinal product”
31 May 2018 - Posted by: Eveline Van Keymeulen
Yesterday, the European Commission adopted Regulation 2018/781 amending Regulation (EC) No 847/2000 as regards the definition of the concept “similar medicinal product” in the context of the Orphan Medicines Regulation. The Regulation extends the definition of “similar active substance”, by clarifying that “[i]f the principal molecular structural features cannot be fully established, the similarity between › Read More
China’s new anti-bribery agency announces pharma probe
31 May 2018 - Posted by: David Shen
China’s State Administration for Market Regulation (SAMR) has announced the launch of a nationwide campaign to crack down on unfair competition and commercial bribery in the pharmaceutical, medical device and educational sectors. The campaign comes at a time when the Chinese government has enacted key amendments to its Anti-Unfair Competition Law (AUCL) and is gearing › Read More