2016-05 Systech Symposium Athens (Sharing)

The
Changing Face of Serialisa0on:

Regulatory Update
24th May 2016 Systech Symposium Athens
Proprietary & Confiden0al | Copyright © 2016 Excellis Health Solu0ons LLC | All Rights Reserved www.excellishealth.com
Christoph Krähenbühl has been involved in Serialisa<on Projects since 2006,
la@erly as Product Security Manager at AstraZeneca, one of the early adopters and global
leaders in pharma serialisa<on.
He was one of the original experts on EFPIA’s Coding and Serialisa0on team and member
of the mul<-stakeholder team (EFPIA, GIRP, PGEU, EAEPC and Medicines for Europe) that
designed the EMVS (European Medicines Verifica<on System) and is currently part of the
European Medicines Verifica<on Organisa<on EMVO Commercial and Partnership team,
suppor<ng the EMVS establishment at na<onal level.
Christoph is also a member of ISPE’s Serializa0on / Traceability Special Interest Group.
In 2012, Christoph founded 3C Integrity, specialising in consul<ng and training in Pharma Serialisa<on which joined
forces on 1st January 2016 with Excellis Health Solu0ons to form 3C Excellis Europe.
3C Excellis provide a unique level of exper<se to strategically support our customers in all aspects of their
Serializa0on / Traceability implementa0on, from Coding and Regulatory exper<se, Manufacturing, ERP- EPCIS, MES,
Warehouse, Supply Chain and Valida<on for Manufactures, Contract Manufacturers, Distributors and Re-packagers.
christophk@3cexcellis.eu
Page 2 Proprietary & Confiden0al | Copyright © 2016 Excellis Health Solu0ons LLC | All Rights Reserved
Excellis Health Solu0ons : Global Capabili0es
•  Privately held Corpora<on, Founded in 2010 Locations
•  Leading System Integrator and Provider of ERP, Supply Chain, New Hope PA (HQ)
Manufacturing & Quality solu<ons 4 E. Bridge St.
Suite 300
•  Embodies an integrated suite of business prac<ces including: New Hope PA, 18938
•  Serializa<on, Track and Trace Phoenix AZ
•  ERP 4889 Gleneagle Dr
Suite 211
•  Supply Chain
Chandler, AZ 85249
•  Manufacturing
Boston MA
•  Computer Systems Valida<on 784 Beaver St
•  Industries Served: Suite 120
Waltham, MA 02452
•  Life Sciences
Europe (HQ)
•  Wholesale Distribu<on Brussels, Belgium
•  Consumer Packaged Goods Manchester , UK
•  Healthcare Asia(HQ)
Bangalore, India
•  Retail
Prac0cal Experience
“Yes, we now have 100 million serial numbers in the data base
– shucks, it was nothing!”
Impact of Counterfeit drugs
Direct Impact on Pa0ent

•  No therapeu<c benefit
•  Over or under dosage
•  Harmful effects including death
Impact on Brand Owners

•  Adverse events
•  Loss of revenue
•  Loss of brand
•  Loss of reputa<on
Wider Impact on Society

•  Loss of efficacy (Malaria drugs, An<bio<cs)
Strategies to fight counterfei0ng and other threats
AC Technology
Threats
Serialisa0on
Data-Matrix code, developed to ISO-standards

Key data elements:
§  Product code (GTIN/NTIN)
§  Randomised unique serial number
§  Expiry date
§  Batch number
§  Na<onal health number (where necessary)
Product #: 09876543210982
Batch: A1C2E3G4I5 2D DM as data carrier of choice:
Expiry: 180500 Compact, Robust, Cost-effec@ve
S/N: 12345AZRQF1234567890
Serialisa0on: From Success to Challenge
2010 2016
Illustra@ons © GS1
Pharma Sales subject to SER / T&T requirements
1100
1085 Base = Global Pharma market (2013) – USD 1,085 BN
1000
900
800
On hold
700
Under Discussion
600
Dran, awai<ng finalisatoin
500 Issued, not ac<ve
400 Ac<ve, scope limited
Ac<ve, expanding scope
300
Ac<ve
200
100
0
2010 2011 2012 2013 2015 2016 2017 2019 2020s
Example EU-FMD “Safety Features”
San Marino
Vatican
Monaco
Key elements of the EU-FMD
Unique Iden0fier Fully harmonised across the EU: 2D barcode containing 4 mandatory elements – 1) product
code, 2) serialisa<on number, 3) batch number and 4) expiry date and – op<onally – as a 5th
element the na<onal reimbursement number (if requested by Member States)
Tamper-Evidence Medicinal Products must be tamper-evidenced (EN standard EN 16679:2014 recommended)
Repackagers Parallel distributors to replace safety features with equivalent features = UI de/re-commission
Scope All prescrip0on medicines (unless white-listed), no OTC medicines (unless blacklisted)
Process Systema0cal end-to-end verifica0on (“before being dispensed to pa/ents e.g. at pharmacy
level”) supplemented by risk-based verifica0ons by wholesale distributors: “Medicines at
higher risk of falsifica/on (returns or medicines not being distributed directly by manufacturers
or marke/ng authorisa/on holders or wholesalers distribu/ng on their behalf)”
Timing Compliance across all 28 MS (+ 3 EEA) on Publica<on of DA + 3 years (or + 9 years for BE, GR, IT)
Establishment and The repository containing the unique iden<fiers should be set up and managed by stakeholders
Opera0on of the (stakeholder model) with access and a supervisory role granted to Na<onal competent
Repository Systems authori<es
Funding Manufacturers bear the cost of the repository systems
“Point of dispense verifica0on”
EU-FMD and EMVS Timeline
July 1, 2011 January 2, 2013 February 9, 2016 February 9, 2019 9,
February
2025
Publication of Transposition of Publication of Compliance date
directive in official directive to MS Safety Features in 25 EU MS + 3
Compliance
journal of EU national law Delegated EEA + CH
date BE, IT, GR
Regulation
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
2009/2010 2012/2013 Q1 2013 Q1 2014 2015

Sweden EMVS System European Hub Link Hub 3 Blueprint
Pharmacy Pilot design Provider selected SecurPharm Providers
Q4 2011 Q4 2012 February 13 2015 March 14 2016

MoU between EFPIA, MoU with additional EMVO stakeholder Bulgarian NMVO (1st
PGEU, GIRP signed stakeholders signed organisation established outside Germany)
EMVS – Data Flow
Wholesaler Pharmacy Wholesaler

Na<onal Na<onal
System System
Na<onal
System Na<onal
System
Pharmacy
European Parallel
Hub Distributor
MAH = Marke<ng
Authorisa<on Holder
Na<onal
Na<onal
System
System
Pharmacy Wholesaler
Pharmacy Wholesaler
EMVS – Data Flow
Wholesaler Pharmacy Wholesaler

Na<onal Na<onal
System System
Na<onal
System Na<onal
System
Pharmacy
European Parallel
Hub Distributor

MAH = Marke<ng
Na<onal
Authorisa<on Holder System
= Brand Owner
Brand Owner Obliga0ons:
•  Ensure all Medicinal Products carry SF
•  Report UIs to EMVS via European Hub
•  Process Excep<ons and Alerts Pharmacy Wholesaler
Page 16 > Require a capable L4 Repository/EPCIS Proprietary & Confiden0al | Copyright © 2016 Excellis Health Solu0ons LLC | All Rights Reserved
Stakeholder responsibility
Pharma - Brand Na0onal
Requirement (rou0ne Parallel Trader / Wholesaler/
Owner and Pharma - CMO Pharmacist Competent
opera0on) Repackager Distributor
Generics Authori0es
no - Marke/ng
1) Pay Yes Authorisa/on Yes
Holders pay
2) Apply UI Yes Yes Yes
3) Apply TE Yes Yes Yes

Connect to EMVS: no - will be done by
4) Yes Yes
Upload UIs customer
Connect to EMVS: Yes: "consumed"
5) for exported packs
Decomm UIs packs
Connect to NMVS: for higher risk voluntary check is
6)
Check UIs shipments possible
Connect to NMVS: "Early dispense" for Yes: Point-of-
7)
Verify UIs ins<tu<ons Dispense
8) Process Alerts Where relevant Where relevant Where relevant Where relevant
Access System for
9) Yes
Overview/Supervision
Serialisa0on – your to-do list
1.  Get Started

Ø  Mobilise your Senior Stakeholders
Ø  Commitment of <me and resources
Ø  Awareness that these can be major projects
2.  Assemble your Team
Ø  Cross-func<onal – affects many parts of the organisa<on
Ø  Get help – Leveraging prac<cal experience is cri<cal
Ø  Don’t rush for the Serialisa<on Technology Stack – understand the full picture
3.  Implementa<on
Ø  Take a holis<c approach: Not a series of separate projects but an exercise that reaches across
your organisa<on
Ø  Define your Serialisa<on User Requirements for flexibility and adaptability
Ø  Engage with the wider ‘to do list’ (but don’t get distracted)
The Change Curve
New opportuni<es
Pharma Sales subject to SER / T&T requirements
1100
1085 Base = Global Pharma market (2013) – USD 1,085 BN
1000
900
800
700
600
500
400
300
200
100
0
2010 2011 2012 2013 2015 2016 2017 2019 2020s
3C Excellis Europe – ac0onable intelligence
3C Excellis Europe have been working with pharma companies – brand owners, generic manufacturers and
contract packers, from large enterprises that are ac<ve world-wide to small specialized companies – in
defining, planning and delivering their serialisa<on programmes. 3C have also been involved in the European
industry stakeholder response to the EU-FMD requirements for many years and are currently suppor<ng the
European Medicines Verifica<on Organisa<on (EMVO) in the rollout of the EMVS (European Medicines
Verifica<on System) at European level and across Member States.
Experience – Excellis unrivalled experience of consul<ng, and industry experience within our management
team. We have helped some of the world’s largest companies with their strategies and deployments.
Methodology – Excellis u<lises a proven methodology, which combines the best understanding of the
external business landscape with the technology environment and proven strategic capabili<es to ascertain
internal requirements, value, and benefits.
Resources – The consul<ng resources of Excellis consist of experienced individuals and subject ma@er experts
from both innova<ve consul<ng environments and leading business and technology organiza<ons. This
unique combina<on provides the best complement of vision and the ability for a successful and pragma<c
implementa<on.

3C Excellis Europe – helping you step up
3C Excellis Europe and Excellis provide a unique level of exper<se to strategically

support your serializa<on journey with a strong experience in the domains of
Regulatory, Manufacturing, ERP- EPCIS, MES, warehouse, supply chain and valida<on
for MAH, CMO, distributors and re-packagers.
3C Excellis Europe and Excellis working with you…
ü  to move beyond mee<ng the narrow focus on regula<ons;
ü  to deliver wider business benefits;
ü  to protect your investment and transform a mandatory expense into a business
opportunity for the industry.


Thank You

3C Excellis Health Solu<ons

www.3cexcellis.eu
Proprietary & Confiden0al | Copyright © 2016 Excellis Health Solu0ons LLC | All Rights Reserved www.excellishealth.com

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The

Changing Face of Serialisa0on:

Direct Impact on Pa0ent

Impact on Brand Owners

Wider Impact on Society

Data-Matrix code, developed to ISO-standards

2009/2010 2012/2013 Q1 2013 Q1 2014 2015

Q4 2011 Q4 2012 February 13 2015 March 14 2016

Wholesaler Pharmacy Wholesaler

Wholesaler Pharmacy Wholesaler

3) Apply TE Yes Yes Yes

1.  Get Started

3C Excellis Europe and Excellis provide a unique level of exper<se to strategically

Das könnte Ihnen auch gefallen

2016-05 Systech Symposium Athens (Sharing)

Hochgeladen von

Dokumentinformationen

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

2016-05 Systech Symposium Athens (Sharing)

Hochgeladen von

Copyright:

Verfügbare Formate

The

Changing Face of Serialisa0on:

Direct Impact on Pa0ent

Impact on Brand Owners

Wider Impact on Society

Data-Matrix code, developed to ISO-standards

2009/2010 2012/2013 Q1 2013 Q1 2014 2015

Q4 2011 Q4 2012 February 13 2015 March 14 2016

Wholesaler Pharmacy Wholesaler

Wholesaler Pharmacy Wholesaler

3) Apply TE Yes Yes Yes

1. Get Started

3C Excellis Europe and Excellis provide a unique level of exper<se to strategically

Das könnte Ihnen auch gefallen

1.  Get Started