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Evalve v Edwards – Review of competing public interests in grant of final injunctions

Marjan Noor

The issue of whether public interest considerations can be relied upon against the grant of a final injunction, or for a carve out in the injunction, is a very live one in disputes in relation to innovative medical devices and pharmaceuticals. In this decision, Edwards argued that, although its PASCAL product used to treat mitral Read More

EMA takes specific steps to reduce possible impact of Covid-19 on pharmaceutical supply chain in EU

Nieke Vanavermaete

In a recent press release, the EMA announced that problems regarding the supply chain of medicines cannot be disregarded as the novel coronavirus (Covid-19) continues to spread. EMA has not (yet) received reports of current shortages or supply disruptions of medicines marketed in the EU due to the outbreak at this point. However, in a Read More

Belgium: New nomenclature for incidents with medical devices

Kaat Van Delm

A group of the International Medical Device Regulators Forum (IMDRF) has recently developed a new nomenclature for the reporting of incidents with medical devices, which will become applicable in 2020. The newly introduced codes will be used primarily to complete medical device reports (MDRs). They will therefore already form part of the new incident report Read More

Dutch Minister of Care announces mandatory “base stocks” to prevent medicine shortages

Sophie van Asten

On 4 November 2019, the Dutch Minister of Care wrote a letter to the House of Representatives, proposing a solution for medicine shortages. In order to prevent shortages, additional stocks of medicines should be built up by obliging medicine manufacturers and wholesalers to build up mandatory buffers (“base stocks”) of five months’ duration, starting in Read More

French ANSM decides to maintain fast-track procedures for clinical trials

Eveline Van Keymeulen

After a successful test phase, the National Agency for Medicines and Health Products Safety (ANSM) announced in a press release dated 18 October 2019 that it would be maintaining the accelerated circuits for medicinal product clinical trial authorisations. The fast tracks were established on 15 October 2018 and then extended to Advanced Therapy Medicinal Products Read More