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.
Terumo loses appeal against Dutch TV broadcaster
23 July 2020 - Posted by: Lars Braams
Two anonymous whistleblowers informed the media about certain serious flaws with respect to Terumo’s syringes, stents and catheters. In the first broadcast of the Dutch TV show “EenVandaag” by AVROTROS it is stated that the syringes can contain (liquid) glue that might contaminate the medicine and the patient. In the second broadcast the quality control › Read More
MA for melatonin refused, Dutch court agrees
20 July 2020 - Posted by: Lars Braams
A Marketing Authorization (MA) is required for selling melatonin in dosages above 0.3 mg. The Dutch Health Care Inspectorate (IGZ) warned repeatedly that it will enforce against the sale of such products, without having an MA. On 16 June, the administrative court of Amsterdam published a decision according to which the decision of the Dutch › Read More
15 July 2020 - Posted by: Eveline Van Keymeulen
Further to the previous publications by the French High Health Authority (HAS), the French Health Ministry published on 21 May 2020 the list of serological tests deemed reliable and validated by the National Reference Centre for respiratory infection viruses (CNR) on its Covid-19 platform (see our previous post here). On the same date, a new › Read More
Belgium: Covid-19 – Coronavirus: serological tests now available
14 July 2020 - Posted by: Tine Carmeliet
Certain serological tests for Covid-19 have been made available to the public in Belgium. The tests examine for the presence of antibodies against Covid-19 and enable patients to know whether they have been infected in the past. On 13 May 2020, a Royal Decree on temporary measures in the fight against the Covid-19 pandemic and › Read More
CJEU – The Grand Chamber reverses the Neurim decision
14 July 2020 - Posted by: Charles Tuffreau
In a landmark decision dated 9 July 2020 concerning the Santen case (C‑673/18), the Grand Chamber of the CJEU clearly reverses the Neurim decision (C‑130/11) and ruled that a MA cannot be considered to be the first MA, for the purpose of Article 3(d), where it covers a new therapeutic application of an active ingredient › Read More