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For those with an interest in life sciences, the rise to prominence of CRISPR, a transformational development in the field of molecular biology and genetics, has been impossible to ignore.
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.
06 March 2019 - Posted by: Kaat Van Delm
On 7 February 2019, the Royal Decree on the liberalisation of the distribution channel of medical devices became applicable (published in the Belgian Official Journal on 28 January 2019). The Royal Decree revokes certain articles in existing Royal Decrees relating to medical devices and two Ministerial Decrees implementing those articles, all of which restricted the › Read More
01 March 2019 - Posted by: Iradj Nazaryar
The Dutch Authority for Consumers and Markets (ACM) has published a new method of analysing product markets in merger investigations with respect to specialised medical care. In this context, the ACM requires merging hospitals and independent treatment centres to provide more detailed information in their merger notifications to the ACM. The starting point for the › Read More
26 February 2019 - Posted by: Jeanne Fabre
The National Agency for Medicines and Health Products Safety (ANSM) recently published its decision of 28 December 2018, imposing a major financial penalty of EUR 348,623 on a pharmaceutical company for a breach of its obligation to supply the national market in an appropriate and continuous manner, and to prevent and avoid any supply difficulties for › Read More
20 February 2019 - Posted by: Anna-Maria Withagen
On 9 January 2019, the Dutch Minister of Health, Welfare and Sports published its report evaluating, for the third time, the Dutch Act on Medical Research involving Human Subjects (WMO). According to the report, the overall functioning of the WMO is satisfactory. As per the evaluation, the goal of the WMO, which is to protect › Read More
19 February 2019 - Posted by: Nele De Backer
European Commissioner for Health and Food Safety, Vytenis Andriukaitis, said that the European Commission will support national competition authorities in their probes against excessive pricing practices in pharmaceutical markets. In addition, the European Commission will continue to monitor pharmaceutical markets itself, as part of its competition policy, and is ready to act against infringements of › Read More