Medical devices

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

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

New Belgian life sciences regulations on pricing and clinical trials published

Tine Carmeliet

Two new Belgian regulations relevant to life sciences stakeholders were published in the Belgian Official Journal on 31 December 2018. A Ministerial Decree adopted on 21 December 2018 has amended the Ministerial Decree of 17 June 2014, which sets the maximum prices for medical implants, refundable and non-refundable medicines, generic medicines and medicines that are imported Read More

French State held liable in PIP case

Eveline Van Keymeulen

On 29 January 2019, in an instance brought by a victim in the infamous case of defective (Poly Implant Prothèse) PIP breast implants, the Administrative Court of Montreuil held the French State liable, considering that AFSSAPS, the predecessor of the current National Agency for Medicines and Health Products Safety (ANSM), did not “take the necessary Read More

MHRA provides further guidance on no-deal Brexit plans

Jacqueline Bore

The MHRA has issued updated guidance on its plans for the regulation of medicines, medical devices and clinical trials in the event that the United Kingdom leaves the European Union on 29 March 2019 without any agreement on its future relationship with the EU and, therefore, without any transitional period. The guidance reflects responses to Read More