Nieke Vanavermaete

Blog Post: 05 MARCH 2021

EMA advises study sponsors to amend Informed Consent Forms

Consent Forms (ICF) to include an explicit reference as to the possibility that EU inspectors would have access to medical records and personal data of clinical trial participants.

Blog Post: 03 MARCH 2021

EU Parallel Trade restrictions and export bans for pharmaceuticals

In 2018, the EU Commission adopted a “Paper on the obligation of continuous supply to tackle the problem of shortages of medicines”, providing that Member States may take measures to prevent or…

Blog Post: 30 NOVEMBER 2020

EU Court says off-label treatments must not be considered when assessing the significant benefit criterion in orphan drugs

On 23 September 2020, the General Court of the European Union (GC) annulled a decision of the European Commission (Commission) that had withdrawn the orphan drug status of Trecondi (Treosulfan).

Blog Post: 15 OCTOBER 2020

Belgium: Covid-19 coronavirus: measures to combat medicine shortages extended again

Since April 2020, the Belgian government has taken measures to avoid medicine shortages during the Covid-19 pandemic. These measures have subsequently been revised and extended in duration four…