Rapid Alert - August 8, 2014
Recall of the products involved in illegal trafficking
The on-going investigation by Italian authorities of falsified medicines of Italian origin has identified a number of illegal supply chains that have resulted in falsified medicines (falsified origin - Last update 08/14/2014) entering the legitimate medicines supply chain throughout the European Economic Area.
Initially authorised Italian wholesalers purchased medicines from ‘bogus’ operators in a number of Member States. The identified bogus operators were;
- CARNELA LIMITED str. Michalaki Karaoli 8, Nicosia, Cyprus, VAT CY10308068X
- ABLE POWER INTERNATIONAL HOLDINGS str. Podmaniczky Utca 57. 2/14, Budapest, Hungary
- AVIMAX HEALTH AND TRADE KFT Fòti U. 4 Szàm, HU-2161 Csomàd, Hungary, VAT HU24206028
- MARS DISTRIBUTIONS KFT Tompa M. Utca 9, HU-8360 Keszthely, Hungary, VAT HU11779074
- EURORIGA MED Import Export - str. Akademika Mstislava Keldisa Iela 12-158, Riga, Latvia, VAT LV40103517211
- LATVAMED INTERNATIONAL Imp. Exp - str. Akademika Mstislava Keldisa Iela 12-158, Riga, Latvia, VAT LV40103572887
- PERSONAL COMMODITY RINGSIDE Municipiul Arad, str.Tribunal Dobra n.18 Judet Arad, Romania, Fiscal code RO31031066 dated 19.12.2012
- ZEAPHARMA S.R.L , Municipiul Targu Jiu, Victoriei, bloc196, scara 3, etaj 2, ap. 10, Judetul GORJ, Romania (note: Zeapharma is authorised as pharmacy, not as wholesaler)
- EXIMP AZ - sro, Bratislava, Slovak Republic
- PIRAMID D.O.O Brniceva Ulica 31, 1231 Ljubljana, Slovenia, VAT 61869937
- TAIN D.O.O Nova Gorica, str. Kridiceva Ulica n.19, Slovenia, VAT 76488632
- HILDONS, Feidiou 3, Thessaloniki Greece, VAT number EL 800528668
At time of writing it is not clear if these bogus organisations had physical custody of the implicated stocks or were simply generators of documentation to legitimise the supply chain. The Italian operators that purchased these medicinal products of falsified origin from the above bogus operators included the following;
- FARMA GLOBAL SNC Via Boscofangone Snc, 80035 Nola, Napoli, VAT 06474151211
- FARMACEUTICA INTERNAZIONALE SRL Via Dell'industria Snc, 83030 Pietradefusi, Avellino, VAT 02715470643
- FARMACIA COZZOLINO DI MARIO & CIRO S.N.C. - Corso Italia 15, 80056 Ercolano, Napoli, VAT 02778921219
- FARMACIA DELLA ROCCA Via Sottotenente Ernesto Cirillo 207, 80041 Boscoreale, Napoli, VAT 06345681214
- PHARMA-TRADE SPA, Via Roma,12 (Operative site: Via S.Abbondio, 158), 80045 Pompei (NA), VAT 07034161211
During the course of this investigation a Maltese operator was identified as supplying medicinal products from a bogus operator above. The Maltese Operator was;
1. PHARMASEA Ltd. 11, Dingli Street, Sliema, Malta
The initial focus of the Italian investigation was on a small number of medicinal products; Herceptin, Remicade, Alimta, Avastin & Mabthera. The network was informed that there was no legitimate supply in the wholesaler supply chain for three of these medicinal products from Italian origin (Herceptin, Avastin and Mabthera), hence the initial alert issued by Germany and subsequent press statements by EMA.
Italian authorities continued to identify the supply chains for the medicinal products concerned. On review of documentation from the Bogus Operators to Italian Operators (purchasers) it became evident that a large number of various medicines (but with small volumes) were supplied utilising the same supply chains as for the five medicinal products listed above. It was evident that in most cases the country of final destination was Germany. The supply chain models were;
A) Bogus Operator sells to Italian Operator who sells to German operator or
B) Bogus Operator sells to Italian Operator who sells to operator in another MS* who subsequently sells to a German operator.
On the basis of the data collected and disclosed by Carabinieri NAS and by the competent Prosecutor, AIFA have painstakingly identified the medicinal products that were supplied via Route A listed above. They are involving other Member States in the supply chain review when one of the 5 authorised Italian wholesalers supplied product to a non-German wholesaler / PDs (Route B above). The investigation has now identified 81 products has being supplied via the bogus operators listed above. These products are listed in the Annex attached. It is likely that this Annex will continue to evolve as more information becomes available.
Action taken by Issuing Authority
AIFA has identified and confirmed the falsified nature of the batches of medicinal products listed in the Annex attached, since they were never legally provided by the MAH, but were sourced by criminal activities still under investigation (such as thefts). It is likely that the list will develop further as more of the investigation is completed. Italian and Maltese authorities are progressing regulatory action against the wholesaler authorisations of the above listed operators.
AIFA is now proposing recall of all confirmed falsified medicines listed in the attached annex, to pharmacy level. The Annex is a searchable excel spread sheet of identified falsified trades. Each Member State should search for trades in which they are the last customer in the supply chain. Once identified these trades form the basis of a specific Member State recall. Please note that each trade lists the batch number of the implicated product, the date of shipment and the quantity in the delivery.
AIFA is proposing recall of the specific trade not the entire batch referenced.
AIFA have a specific request that all recalled medicines, if possible, should shipped back to the supplying Italian wholesaler. Italian authorities may use these products (and associated documentation), in evidence at forthcoming criminal trials