Additional information on medicinal products of Italian origin in the EU for parallel importers and distributers

Based on the current situation, the Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (Bundesamt für Arzneimittel und Medizinprodukte, BfArM) would like to indicate that they have added some information to the jointly published note of 20 October 2014.

According to the Italian medicines authority AIFA (Agenzia Italiana del Farmaco), the list of medicines supplied predominantly to hospitals and hospital pharmacies in Italy by the authorisation holders, dated 20 October 2014 will be extended by several medicinal products.

Italian hospital pharmacies, as a rule, do not have a license for wholesale, so that it can be assumed that these medicines cannot be exported from Italy.

The following medicines are currently known to be included in this list (as per 6 February 2019):

Alecensa, Bavencio, Citovirax, Cotellic, Erivedge, Erbitux, Esbriet, Fuzeon, Gazyvaro, Hemlibra, Invirase, Kadcyla, Ocrevus, Perjeta, Tarceva, Tecentriq, Zelboraf.

The note of 20 October 2014, which is still valid, comprises the following medicines:

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

Therefore, the PEI and the BfArM recommend that the entire supply chain for these medicines should be checked for its legal status, in so far as the medicines have been or are planned to be sold or distributed on the German market.

The legal status can also be clarified with the Italian authority via the federal German authorities BfArM and PEI (ras@bfarm.de; pharmakovigilanz@pei.de).