Freedom of information in the Netherlands: bibliographic MA application becomes (partly) public. Registration dossier not protected by database rights

Lars Braams

Medice is the marketing authorisation (MA) holder of the medicinal product Amfexa, used for the treatment of ADHD. A third party successfully requested the Dutch Medicines Agency to publish the marketing authorisation dossier on the basis of the Dutch Open Government Law. Medice unsuccessfully opposed the publication of its MA application. The MA application concerned Read More

Netherlands: Covid-19: Emergency Act temporarily amends Dutch Patents Act

Isabel Rutten

In June 2020, the Dutch House of Representatives passed an Emergency Act to temporarily amend the Dutch Patent Act, allowing patent holders and applicants more time to secure and preserve their patents. Before the introduction of the Emergency Act, the Covid-19 pandemic may have affected companies that owned patents or were in the process of Read More

Terumo loses appeal against Dutch TV broadcaster

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

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

Covid-19 coronavirus: Measures introduced to mitigate healthcare consequences in the Netherlands

Iradj Nazaryar

In March and April 2020, the Dutch Health and Youth Care Inspectorate (IGJ) announced various measures to mitigate the consequences of the Covid-19 coronavirus pandemic on the Dutch healthcare sector: Permission to supply medical devices that are not CE marked . Manufacturers and suppliers may temporarily supply medical devices without CE markings provided there are Read More