EMA update on stolen vials of Herceptin

The European Medicines Agency has provided an update on the latest information relating to the stolen vials of Herceptin (trastuzumab) in Italy (The Pharma Letter April 16). The vials, some of which were tampered with, were later re-introduced illegally into the supply chain in some countries.

The Italian law enforcement authorities are currently investing the theft. However, the situation goes beyond European Union and national current practices for handling quality or product defects; these are extraordinary circumstances driven by criminal activities that require special measures and strong collaboration from authorities across the EU.

National competent authorities are working rapidly to identify all concerned batches and put in place appropriate measures to protect the health of EU citizens. In parallel to the investigations, all vials suspected of being affected are being recalled from the EU market. In addition, member state authorities are considering temporary measures including quarantine of suspected products or restriction of parallel distribution of the concerned products.