MHRA GDP Symposium

Novotel London West, London

8 & 10 December 2015

#GMDPevents
The Threat from Falsified
Medicines
Presented by: Christopher Morris, MHRA Enforcement

#GMDPevents
 Agenda

• Recent MHRA Enforcement counterfeit investigations

• FMSM Watchlist and new risk assessment process

• The Unregulated Supply chain

• Emerging threats and future medicines at risk of

counterfeiting

3 #GMDPevents
 Counterfeits in the UK Supply Chain
Date Medicine Purchased Falsified How identified
from
April 2013 Remicade Romania Packaging Batch number
falsified discrepancies
September Symbicort Lithuania Packaging Batch number
2013 Turbohaler falsified discrepancies
April 2014 Herceptin Italy Tampered / Vials contained liquid
refilled instead of lyophilised
powder
June 2014 Kaletra Latvia Packaging PIL substandard
falsified
November Symbicort Bulgaria Packaging Slight discrepancies in
2014 Turbohaler Falsified packaging colour and
braille
June 2015 Kaletra Latvia Packaging PIL substandard
Flasified

4 #GMDPevents
 Remicade – Op McKinley
• In April 2013, A German wholesaler identified batch number
discrepancies on 200 Remicade units.
• Products sold to them by UK Wholesaler.

5 #GMDPevents
 Comparison with Control Sample
Suspect Control Suspect Control

Suspect Control Suspect Control

6 #GMDPevents
 Herceptin 150mg
• Case concerns the discovery of counterfeit Herceptin (breast cancer drug) in the
wholesale supply chain in the UK and the EU.
• On 2 April 2014, the Paul-Ehrlich Institute in Germany identified a number of
suspected counterfeit batches of Herceptin.
- batch number of the primary and the secondary packaging differed
- the products were partially liquid (although it’s a lyophilisat)
- residue of product was partially outside the vial
- some products seemed to have been tampered with.

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 Herceptin (Cont’d)
• Some of the counterfeited Herceptin had gone through UK
wholesalers.
• 22 vials of Herceptin from the suspect batch were seized
from two UK wholesalers
• 10 were confirmed as being tampered with and/or containing
liquid rather than powder
• All the Herceptin was purchased from Italian Wholesalers
• Investigations in Italy suggested that the Herceptin was
stolen from hospitals and refilled.
• It has since been found that up to 60 different medicines
have been identified as stolen in Italy since 2012 and
subsequently sold into EU wholesale chain.

8 #GMDPevents
 Kaletra 200mg/50mg
• Case concerns the discovery of falsified Kaletra (HIV treatment) in the
wholesale supply chain in the EU.
• In June 2014, German authorities were alerted to 3 batches of Kaletra
which were identified as having packaging not characteristic with the
genuine product.
• Testing later determined the tablets to be genuine but the PILs had been
falsified
• Two UK wholesalers were identified as the source of the Kaletra by the
German authorities.
• MHRA investigations determined that the UK wholesalers had purchased
the Kaletra from a Latvian Wholesaler.
• Batch number analysis shows that the Kaletra was
originally distributed in Turkey and Israel, in English livery.
• A second case involving the same UK wholesaler from the same Latvian
wholesaler and same batch number in June 2015.
9 #GMDPevents
 Symbicort 320/9 Turbohaler
• Case concerns the discovery of suspected counterfeit Symbicort (asthma inhaler)
in the wholesale supply chain in the UK.
• On 9 September 2013, a UK wholesaler discovered packaging discrepancies on
246 packs of parallel imported Symbicort from Lithuania in Bulgarian livery.
• The packaging all described PAWT as the batch number whereas a wide range of
other batch numbers were found on the actual product.
• Further enquiries by MHRA discovered a further 98 suspect packs received from
another UK wholesaler. Whilst the German authorities discovered a further 90 at a
wholesale dealer.
• It was later established that the batch numbers on the actual product were for the
non-EU market, with Turkey as the common denominator. The PAWT batch
number was for the EU market.
• Testing revealed the product to be genuine but the packaging to be falsified.
• Turkish Nationals Arrested as a result of a separate counterfeit case are probably
linked.

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 Symbicort 320/9

• On 29 October 2014, a suspected falsified batch of Symbicort

was identified in Germany.
• A UK Wholesaler purchased the stock from a Bulgarian
wholesaler.
• A second UK wholesaler had also purchased some of this
stock from the first UK wholesaler.
• In total, 2487 doses were seized by the MHRA and German
Authorities.
• Testing showed that the product was genuine but both the
primary and secondary packaging had been falsified.
• None of the counterfeit product went beyond the wholesale
chain.
11 #GMDPevents
 Symbicort 320/9 (Cont’d)
Red colouring is irregular at top

Counterfeit PIL is wider than

genuine
Red colouring is easily removed

12 #GMDPevents
 Symbicort 320/9 (cont’d)
Counterfeit Genuine

Blue from side panel can be

seen from front view

Dot missing from braille

Counterfeit Genuine

13 #GMDPevents
 Counterfeit Packaging / Diversion MO

Once in EU wholesale chain with legitimate EU batch

numbers, the medicines are traded throughout
Europe. The falsified medicines are often only
identified when a Parallel Importer checks the batch
numbers on both primary and secondary packaging

The re-packaged medicines are

sold into the wholesale chain in
Eastern Europe

Genuine medicines for the non-EU market are

re-packaged into falsified packaging with
genuine EU batch numbers

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 Tampering/Refilling MO

15 #GMDPevents
 The Watchlist
Product Therapeutic Class Manufacturer Risk Assessment
Kaletra HIV Abbvie 22

Symbicort Turbohaler (Inhaler) - Astra Zeneca 21

Asthma
Herceptin Oncology Roche 19

Cialis Erectile dysfunction Eli Lilly 18

(Tadalafil)
Viread Anti-retroviral Gilead 18

Norditropin Simplexx Hormone growth Novo Nordisk 17

deficiency Limited

Viagra Erectile dysfunction Pfizer 16

(Sildenafil)

Levitra Erectile dysfunction Bayer 16

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 The Monitoring List
Product Therapeutic Class Manufacturer

Truvada Anti-retroviral Gilead

Tramadol (Tramadol
Hydrochloride) Analgesic Bristol Laboratories
- Reclassification as a Class
C drug.

Rivotril Anti-epileptic Roche

Postinor (Levonorgestrel) Emergency contraception Bayer
Remicade Anti-inflammatory (Immunological) Merck, Sharp and Dohme
Sutent Oncology Pfizer
Avastin Oncology Roche
Mabthera Oncology Roche
Exjade Heavy Metal Chelator Novartis Pharmaceuticals UK
Ltd
Humira Antirheumatic Abbvie Ltd
Neulasta Oncology Amgen Ltd
Zyvox Anti-biotic Pharmacia Ltd

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 The Unregulated Supply Chain
Viagra - B314833021
B31833024
B12148332
B14830238

Cialis - 05668
AD47385
AC075060
C251322

Levitra - BXB8551

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 Emerging Trends
• Continued threat of diversion/re-packaged meds from
Turkey.

• Potential weakness in the Greek market.

• Tampering/refilling likely to become more prevalent and

more professionally done.

• China/Hong Kong still at the forefront of counterfeit

medicine manufacturing. Including the export of APIs.

• Counterfeits already seen in China of emerging and

expensive medicines such as Sovaldi

19 #GMDPevents
 Christopher Morris
Intelligence Analyst - Counterfeits
Enforcement Group

#GMDPevents
 © Crown copyright 2015
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