EMA updates guidance on drug/device consultation procedure

The European Medicines Agency (EMA) has published an updated version of its guidance document covering the consultation procedure that follows when a manufacturer requests a review of its technical documentation for a medical device that includes a drug that acts with secondary effect.

The document is titled ‘European Medicines Agency recommendation on the procedural aspects and dossier requirements for the consultation to the European Medicines Agency by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device or active implantable medical device’, and takes effect from 1 September 2012.