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

France: Modification and simplification of the reimbursement evaluation procedure for certain medicinal products

Eveline Van Keymeulen

On 3 July 2019, a new Decree was published which modifies the evaluation procedure of generic and biosimilar medicines by the Transparency Commission of the High Health Authority (HAS). This Decree seeks to simplify the assessment procedures of such medicines in order to speed up their financing by French Social Security. The principle set out Read More

Germany Improves Patients’ Access to Medical Cannabis

Eda Zhuleku

The new Law for More Safety in the Supply of Pharmaceuticals in Germany (Gesetz für mehr Sicherheit in der Arzneimittelversorgung- GSAV) which has been in force since 16 August amends the law regarding the prescription and sale of medical cannabis in Germany. Since 10 March 2017, it has been possible for medical cannabis to be prescribed Read More