Regulatory & compliance

New German Appointment Service and Supply Act: Implications for investors in the dental industry

Eda Zhuleku

On 14 March 2019, the German Parliament (Bundestag) adopted the German Appointment Service and Supply Act (Terminservice- und Versorgungsgesetz; TSVG), which will come into force in May 2019, as the German Federal Council (Bundesrat) did not veto the law. During the legislative process, it was feared that the Act would have significant impact on the Read More

New Belgian Royal Decree liberalises the distribution of medical devices

Kaat Van Delm

On 7 February 2019, the Royal Decree on the liberalisation of the distribution channel of medical devices became applicable (published in the Belgian Official Journal on 28 January 2019). The Royal Decree revokes certain articles in existing Royal Decrees relating to medical devices and two Ministerial Decrees implementing those articles, all of which restricted the Read More

French regulator (ANSM) imposes major financial penalty on a pharmaceutical company for shortage of medicine

Jeanne Fabre

The National Agency for Medicines and Health Products Safety (ANSM) recently published its decision of 28 December 2018, imposing a major financial penalty of EUR 348,623 on a pharmaceutical company for a breach of its obligation to supply the national market in an appropriate and continuous manner, and to prevent and avoid any supply difficulties for Read More

Positive outcomes of third evaluation of Dutch Act on Medical Research involving Human Subjects

Anna-Maria Withagen

On 9 January 2019, the Dutch Minister of Health, Welfare and Sports published its report evaluating, for the third time, the Dutch Act on Medical Research involving Human Subjects (WMO). According to the report, the overall functioning of the WMO is satisfactory. As per the evaluation, the goal of the WMO, which is to protect Read More

Coordination amongst member states on medicines’ prices supported by the European Commission

Nele De Backer

European Commissioner for Health and Food Safety, Vytenis Andriukaitis, said that the European Commission will support national competition authorities in their probes against excessive pricing practices in pharmaceutical markets. In addition, the European Commission will continue to monitor pharmaceutical markets itself, as part of its competition policy, and is ready to act against infringements of Read More