AIFA. Withdrawal from the market of products involved in illicit trafficking

The Agency has disseminated a Rapid Alert to all Member States through which the competent authorities have been asked to withdraw from the market the drugs indicated in the list "products involved in illegal trafficking“

Safety   AIFA – 08/11/2014

On 8 August 2014, the Agency disseminated a Rapid Alert to all Member States through which the competent authorities were asked to withdraw from the market the medicines indicated in the list "products involved in illegal trafficking” attached to the report issued, which shows the trade names (and related data) of over 60 products subject to illegal transactions.

It should be noted that the products recalled from the market are exclusively the products involved in the individual transactions indicated in the above list and, therefore, not entire lots.

It is also confirmed that, as already reported in previous AIFA communications, the products subject to illegal transactions through unauthorized operators are only those exported to other European countries. No problems have currently emerged with respect to the same products marketed throughout the country, even where they bear the same lot number as those contained in the list.

The Italian and foreign operators involved

The Rapid Alert issued on 8 August represents a further evolution of the investigations launched by the Italian authorities into the "Herceptin case", during which illegal supply channels were identified, through which they were marketed and exported to the countries of the European Economic Area drugs falsified with respect to the origin, as they are accompanied by false documentation (false sales invoices) produced by the unauthorized foreign operators indicated below:

1. CARNELA LIMITED str. Michalaki Karaoli 8, Nicosia, Cyprus, VAT CY10308068X
2. ABLE POWER INTERNATIONAL HOLDINGSstr. Podmaniczky Utca 57. 2/14, Budapest, Hungary
3. AVIMAX HEALTH AND TRADE KFT Fòti U. 4 Szàm, HU-2161 Csomàd, Hungary, VAT HU24206028
4. MARS DISTRIBUTIONS KFT Tompa M. Utca 9, HU-8360 Keszthely, Hungary, VAT HU11779074
5. EURORIGA MED Import Export – str. Akademika Mstislava Keldisa Iela 12-158, Riga, Latvia, VAT LV40103517211
6. LATVAMED INTERNATIONAL Imp. Exp – str. Akademika Mstislava Keldisa Iela 12-158, Riga, Latvia, VAT LV40103572887
7. PERSONAL COMMODITY RINGSIDE Municipiul Arad, str.Tribunal Dobra n.18 Judet Arad, Romania, Fiscal code RO31031066 dated 19.12.2012
8. ZEAPHARMA SRL , Municipiul Targu Jiu, Victoriei, bloc196, scara 3, etaj 2, ap. 10, Judetul GORJ, Romania (note: Zeapharma is authorized as a pharmacy, not as a wholesaler)
9. EXIMP AZ – sro, Bratislava, Slovak Republic
10. PIRAMID DOO Brniceva Ulica 31, 1231 Ljubljana, Slovenia, VAT 61869937
11. TAIN DOO Nova Gorica, str. Kridiceva Ulica n.19, Slovenia, VAT 76488632
12. HILDONS, Feidiou 3, Thessaloniki Greece, VAT number EL 800528668

On the basis of what was reconstructed through the checks carried out on the acquired documentation, the following Italian operators would have been involved in these transactions, who would have directly purchased drugs from unauthorized foreign operators:

1. FARMA GLOBAL SNC Via Boscofangone Snc, 80035 Nola, Naples, VAT 06474151211
2. PHARMACEUTICAL INTERNATIONAL SRL Via Dell'industria Snc, 83030 Pietradefusi, Avellino, VAT 02715470643
3. COZZOLINO DI MARIO & CIRO SNC PHARMACY – Corso Italia 15, 80056 Ercolano, Naples, VAT 02778921219
4. PHARMACY DELLA ROCCA Via Sottotenente Ernesto Cirillo 207, 80041 Boscoreale, Naples, VAT 06345681214
5. PHARMA-TRADE SPA, Via Roma,12 (Operative site: Via S.Abbondio, 158), 80045 Pompei (NA), VAT 07034161211

The investigations also made it possible to identify an authorized Maltese operator - PHARMASEA Ltd. 11, Dingli Street, Sliema, Malta - supplied by a wholesaler without the necessary authorizations for the distribution of medicines.

The list of national and foreign operators involved was previously disseminated by AIFA, both through the European Rapid Alert system (14 May 2014 and 1 July) and through its institutional portal (19 May 2014, 6 June 2014).
This update therefore represents a development with respect to the issue of suspicious transactions under current scrutiny.

Results of recent control activities

Based on the checks carried out on the documentation relating to illicit trafficking between Italian operators and unauthorized foreign operators, it was possible to identify the involvement of further drugs, and to reconstruct the recurring pattern of transactions, most of which have Germany as their final destination:

• A. sale by the unauthorized foreign operator (1) to the authorized Italian operator (2) and subsequent sale by the latter to an authorized operator in Germany (3)
• B. sale by the unauthorized foreign operator (1) to the authorized Italian operator (2), sale by the latter to an operator of another member state (3) which in turn resells to an operator in Germany ( 4)

AIFA has reconstructed the "path" of the drugs marketed according to the first scheme (A), which currently appear to be over 60 (by type and not in terms of quantity), as reported in the "List of products subject to illegal transactions".

This list may be further integrated should further elements and information emerge.

Finally, it should be underlined that the Agency, through the Rapid Alert issued, has expressly requested the Member States to allow all the products indicated to be made available to the competent Italian prosecutors, in order to use them as possible evidence in the context of future trials penalties.