Italian case about stolen medicine affects Denmark

29 August 2014

21 stolen packages of medicine from Italy have probably been sold on the Danish and German markets. The Danish Health and Medicines Authority has asked the company to recall the medicine (the batch).

The stolen packages contain the medicinal product Abilify®, oral solution, 1 mg/ml, which is used for the treatment of schizophrenia and mania. Up to 21 of the packages have been repacked by the company EuroPharmaDK and then sold on the Danish and German markets.

Stolen medicinal products are by definition falsified – even if they are manufactured in the right way – because they have been distributed outside the legal distribution chain. Consequently, we have asked the company to recall any unsold packages of the medicinal product (the batch) from pharmacies.

In connection with its control during the repackaging, EuroPharmaDK found no signs that the contents of the stolen medicine packages have been manipulated. The medicinal product is very stable and there are no special storage requirements. Against this background, we assess that the quality of the medicinal product has not been affected. We recommend that patients in treatment with Abilify oral solution from EuroPharmaDK continue the treatment.

Italian case about stolen medicinal products

The case about stolen medicinal products was first mentioned on our website in April 2014; at that time the case was about cancer medicine.

As the investigation progressed, it was found that the case also involved other types of medicine that were not sold in Denmark. The case is still being investigated in Italy in collaboration with other European authorities. A number of illegal companies have distributed the stolen medicinal products in the legal distribution chain in Europe.

We follow the situation closely and cooperate with other European drug regulatory authorities. When we get new information about the stolen medicine, we will investigate whether the medicine has been distributed to Danish pharmacies or consumers.

Stolen from hospitals in Italy

The medicine was stolen from hospitals and during transportation in Italy. Illegal companies using false authorisations in several European countries then sold the medicine in the legal distribution chain. After having been sold in the legal distribution chain again, the medicine could potentially have been distributed between several authorised wholesalers, all of which have bought the products in good faith just like EuroPharmaDK.

At present, no Danish companies have traded directly with the illegal companies.

So far the investigation in Italy has revealed that the following illegal companies have distributed medicines without holding a valid authorisation:
1. CARNELA LIMITED str. Michalaki Karaoli 8, Nicosia, Cyprus, VAT CY10308068X
2. ABLE POWER INTERNATIONAL HOLDINGS str. 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 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)
9. EXIMP AZ - sro, Bratislava, Slovak Republic
10. PIRAMID D.O.O Brniceva Ulica 31, 1231 Ljubljana, Slovenia, VAT 61869937
11. TAIN D.O.O Nova Gorica, str. Kridiceva Ulica n.19, Slovenia, VAT 76488632
12. HILDONS, Feidiou 3, Thessaloniki Greece, VAT number EL 800528668

The below companies holding a valid authorisation have traded directly with the non-authorised companies and then distributed the medicine to a number of European countries:
1. FARMA GLOBAL SNC Via Boscofangone Snc, 80035 Nola, Napoli, VAT 06474151211
2. FARMACEUTICA INTERNAZIONALE SRL Via Dell'industria Snc, 83030 Pietradefusi, Avellino, VAT 02715470643
3. FARMACIA COZZOLINO DI MARIO & CIRO S.N.C. - Corso Italia 15, 80056 Ercolano, Napoli, VAT 02778921219
4. FARMACIA DELLA ROCCA Via Sottotenente Ernesto Cirillo 207, 80041 Boscoreale, Napoli, VAT 06345681214
5. PHARMA-TRADE SPA, Via Roma,12 (Operative site: Via S.Abbondio, 158), 80045 Pompei (NA), VAT 07034161211
6. PHARMASEA Ltd. 11, Dingli Street, Sliema, Malta

The purpose of the further investigation is to unravel the supplier chain following these wholesalers.