Brief: DG Sanco confirms FMD safety features timeline

The European Commission has confirmed that the delegated act on safety features for medicines will be published before the end of the year.

It is now finalising the drafting of the delegated act - on the basis of the outcome of the impact assessment, and after extensive consultation of the Member State expert group - and expects to adopt it before the end of the second quarter. That puts the act on track to become applicable in the first half of 2018.

Confirmation of the timelines comes from the minutes of the March 17 meeting of DG Sanco's Pharmaceutical Committee, which can be downloaded here.