1. Falsified Medicines Case Study Operation McKinley Mark Jackson – Head of Intelligence MHRA

2. OVERVIEW Introduction MHRA Investigations MHRA Actions Laboratory Analysis & discrepancies Conclusions

3. DateMedicineIndicationMAHUnit Price Total Value Purchased From Falsified April 2013 RemicadeCrohn’s Disease MSD£420£84,000RomaniaPackaging falsified Sept 2013 Symbicort Turbohaler AsthmaAstra Zeneca £38£9,348LithuaniaPackaging falsified April 2014 HerceptinBreast Cancer Roche£410£4,100ItalyTampered/refilled June 2014 KaletraHIVAbbvie£280£61,040LatviaPackaging falsified Nov 2014 Symbicort Turbohaler AsthmaAstra Zeneca £38£94,506BulgariaPackaging falsified

4. Remicade – Op McKinley

5. ISMAIL stated that he purchased 200 units at £1,090 per unit (£218,000) from Muntera Filoteos (Romania) Metalux (UK) then purchased the consignment at £1130 per unit (£226,000) ISMAIL arranged for CPS Logistics (UK) to transport the consignment to UK, where Metalux (UK) would collect Interview – 23 April

6. Remicade – Op McKinley On 5 April, ISMAIL was informed that the product was being returned due to discrepancies Metalux (UK) returned 140 units of Remicade to CPS Logistics (UK) where ISMAIL arranged for it to be returned to Romania ISMAIL stated that he never sees the products he purchases Interview – 23 April (Cont’d)

7. Movement of Goods Advipha & INOPHA – German Wholesalers Direct Pharmaceuticals – UK Wholesaler Metalux – UK Wholesaler Life Pharmaceuticals – UK Wholesaler Muntera Filoteos - Romanian Wholesaler SUPPLYSUPPLY RETURNRETURN

8. Remicade – Op McKinley

9. Copy of the licence supplied by RODU

10. Laboratory Analysis & Discrepancies

11. ISMAIL - a victim of fraud?

12. MHRA Licensing Unit Actions 16 April – Life Pharmaceuticals UK Wholesale Dealer’s Licence Suspended –Incorrect address details –Using a logistics company (CPS) not on the licence –Incorrect RP details –Incorrect contact details for licence holder January 2014 – Licence Revoked

13. Comparison with Control Sample Outer Packaging SuspectControl

14. Comparison with Control Sample SuspectControl Comparison with Control Sample Outer Packaging

15. Comparison with Control Sample SuspectControl Comparison with Control Sample Outer Packaging

16. Comparison with Control Sample SuspectControl Comparison with Control Sample Inner Packaging

17. Batch Distribution Analysis Batch number printed on packaging & labelling - 2RMA66504 was for Romania and Bulgaria Batch number printed on vial 2RMKA828 and 2RMKA834 were for Turkey 2RMKA822 for Turkey and Switzerland 2RMKA831 for Turkey and Croatia

18. Conclusions Remicade legitimately manufactured in Netherlands Remicade was re-packaged in Turkey ISMAIL groomed by Romanian Company with genuine smaller orders ISMAIL a victim of fraud ISMAIL now suspected of involvement in criminality in an attempt to repay his debts

19. Thank you All Enforcement enquiries and potential referrals to: MHRA Case Referrals Centre casereferrals@mhra.gsi.gov.uk or tel +44 (0)20 3080 6330 Mark Jackson Head of Intelligence Medicines and Healthcare products Regulatory Agency +44 (0) 203 080 6332 mark.jackson@mhra.gsi.gov.uk