Information for parallel importers and distributers on the current suspected cases of counterfeiting of medicines of Italian origin in the EU

In the light of recent events, the Paul-Ehrlich-Institut (PEI) draws the attention to a note it published jointly with the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, Federal Institute for Drugs and Medical Devices) on 20 October 2014, which is still applicable today.

Parallel importers and distributers are requested to clarify with the Italian Medicines Agency AIFA (Agenzia Italiana del Farmaco), whether medicines of Italian origin supplied predominantly to hospitals and hospital pharmacies by marketing authorisation holders are provided in a legal manner. As a rule, Italian hospital pharmacies do not have a license for wholesale so that it can be assumed that these medicines cannot be exported from Italy.

Based on the current state of knowledge (as per 22 August 2018), the following medicines are affected:

Afinitor, Atripla, Avastin, Caelyx, Ecalta, Eviplera, Exjade, Faslodex, Gilenya, Herceptin, Iressa, MabThera, Nplate (250mg), Prezista, RoActemra, Stelara, Sutent, Tasigna, Truvada, Tysabri, Velcade, Viramune, Viread, and Votrient.

In addition to the Italian medicines authority the clearification can also be performed via the Federal medicines authorities BfArM and PEI (ras@bfarm.de; pharmakovigilanz@pei.de).