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.

French medical cannabis pilot: call for applications for suppliers launched today – responses required by 24 November

Eveline Van Keymeulen

Today, the French National Agency for Medicines and Health Products Safety (ANSM) has officially launched the call for applications (“appel à candidatures”) for medical cannabis suppliers to participate in the pilot programme that will be started by 31 March at the latest.  The call for applications follows the publication of the ministerial order providing the Read More

French medical cannabis pilot programme to start by 31 March 2021 at the latest, confirms long-awaited decree

Eveline Van Keymeulen

Today, the long-awaited decree regarding the French medical cannabis pilot programme was published in the Official Journal.  The pilot programme, discussions on which were initiated in 2018, was officially authorised by law in December 2019, but publication of the necessary implementing decree incurred significant delay because of the COVID-19 health crisis. Today’s decree proclaims that Read More

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

France: New approach for reimbursement of health products

Jeanne Fabre

On 27 August 2020, French decree no 2020-1090 of 25 August 2020 was published in the Official Journal. The decree was issued to harmonise and simplify various procedures for the reimbursement of medicines, health products and services. One of the key changes introduced by the decree is that the costs of contraceptives for insured minors Read More

Belgium – Covid-19 coronavirus: using saliva samples to detect SARS-CoV-2 as an alternative to sampling via a deep nasal swab?

Veerle Pissierssens

The Belgian federal taskforce on testing and shortages commissioned a study that was launched on 28 May 2020 on the use of saliva samples as an alternative to sampling via a deep nasal swab (nasopharyngeal) to detect SARS-CoV-2 using PCR molecular detection tests. The purpose of the study, supported by Sciensano, a public research institution, Read More