European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work...
Transcript of European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work...
![Page 1: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/1.jpg)
© GS1 2017
European Union (EU) Falsified Medicines Directive
Mr. Mike Rose, Vice President, Supply Chain VisibilityJohnson & Johnson
18 October 2017
![Page 2: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/2.jpg)
Mike RoseVice President, Supply Chain VisibilityJohnson & Johnson Supply Chain
Chairman, EFPIA Supply Chain WorkgroupCo-Chair, EFPIA-Medicines for Europe FMD Workgroup
The Promise of SerializationEU Falsified Medicines Directive (FMD)
![Page 3: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/3.jpg)
Johnson & Johnson • World’s largest science & technology
company focused solely on healthcare
• More than 275 operating companies in 60 countries
• Selling products in more than 175 countries
• Approximately 128,000 employees worldwide
88
![Page 4: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/4.jpg)
Johnson & Johnson PortfolioConsumer
Baby Care • Body Care • Facial Skin Care • Sun Care •Feminine Personal Care • Allergy Care •
Compromised Skin Care • Cough and Cold Care • Digestive Health • Oral Care • Pain Care
Medical DevicesWound Closure & Surgical Devices • Minimally Invasive Surgery • Joint Replacement • Sterilization • Eye Health
• Diabetes Care
PharmaceuticalsOncology • Infectious Diseases & Vaccines •Immunology • Cardiovascular & Metabolism •
Neuroscience & Pain
89
![Page 5: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/5.jpg)
90
![Page 6: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/6.jpg)
Serialization and TraceabilityA unique identification number assigned to each item identifying it with a product number and associated serial number
It’s applied at every package level - bottle, case, pallet
These unique numbers are uploaded into a database and can provide actionable product intelligence
91
![Page 7: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/7.jpg)
EU Falsified Medicines Directive
Product Safety Features
Product Safety Features
Authenticity
Pack identity
Tamper evidence
Authenticity
Pack identity
Tamper evidence
Good Distribution
Good Distribution
Wholesalers & Brokers
GDP
Wholesalers & Brokers
GDP
Active Substances
Active Substances
InternetSales
InternetSales
Community logoCommunity logo
Registration API activities
GMPs forexcipients
Feb 9, 2019 Q1 2014 July 2, 2013 2015
Jan 2, 2013
92
![Page 8: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/8.jpg)
• Secure the legitimate supply chain
• Be proactive as market partners
• Stakeholder-governed modelFunctioningHarmonisedCost-effective Inter-operable
• Established the European Medicines Verification Organization (EMVO)
• Local governance through National Medicines Verification Organizations
European Stakeholder ModelAligned on common goal to protect patients
93
![Page 9: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/9.jpg)
EU Hub and National Medicines Verification Systems (NMVS)
PharmaceuticalManufacturer
ParallelDistributor
Pharmacy Wholesaler
EuropeanHub
NationalSystem
NationalSystem
National BlueprintSystem
National BlueprintSystem
National BlueprintSystem
German NationalSystem
94
![Page 10: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/10.jpg)
COUNTRY READINESS
95EMVO PMMR SEPTEMBER 2017
2 2 2 24 4
6 6 6 6 6 6
79 9 9
8 87 7
11 11 11 11
2321 21 21 20 20 19 19
15 15 15 15
0
5
10
15
20
25
30
Oct‐16 Nov‐16 Dec‐16 Jan‐17 Feb‐17 Mar‐17 Apr‐17 May‐17 Jun‐17 Jul‐17 Aug‐17 Sep‐17
rest
Late
Main
Early
![Page 11: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/11.jpg)
EXECUTIVE SUMMARY BLUEPRINT TENDENCY
96
15
14
220
31
11810
16
24
6
27
13
28
4
3
26
19
17
8
12
30
9
32
2529
22
7
11
5
23
21
Blueprint candidate
Small Country Blueprint
Blueprint open
Standalone system
Non EU Countries
EMVO PMMR SEPTEMBER 2017
![Page 12: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/12.jpg)
EXECUTIVE SUMMARY COUNTRY READINESS
97
15
14
220
31
11810
16
24
6
27
13
28
4
3
26
19
17
8
12
30
9
32
2529
22
7
11
5
23
21
Early Adopter
Main Stream
Late Follower
Non EU Countries
EMVO PMMR SEPTEMBER 2017
![Page 13: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/13.jpg)
Page 98
GS1 - GTINAustria*, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark**, Estonia, Finland**, Germany*, Hungary, Iceland**, Ireland, Latvia, Lithuania, Malta, Netherlands, Norway**, Poland**, Portugal, Romania, Slovakia, Slovenia, Spain**, Sweden, Switzerland, UK
* GTIN for multi country - shared packs** Some countries will allow GTIN or NTIN
GS1 - NTINAustria*, France, Germany*
* For market specific packs
TBCItaly and Greece (coding requirements under discussion)
Some countries (outlined in red) also require a national number in the 2D Barcode when using GTIN
Pack coding harmonisation has increased, but . . .
• To date there have been a number of important decisions made which help harmonise the FMD implementation across Europe:
– Choice of data carrier (2D DataMatrix)– Choice of coding scheme (ability to use International standards such
as GS1)
![Page 14: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/14.jpg)
Page 99
. . . But there are still coding/ labelling challenges
• However there are other factors which will drive unnecessary complexity and cause issues with FMD implementation if not avoided:
– Human readable text order– Prefix (heading) location– Use of labels to apply coding– Barcode transition requirements– Encoded data order– Application identifier use– Printed format of the 2D Data Matrix– Inclusion of the national number in the 2D Data Matrix
![Page 15: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/15.jpg)
Page 100
Complexity Drivers
Complexity Driver Overview Position Table Advocacy DocHuman readable text order Complete Complete Final DraftPrefix (heading) location Complete Complete Final DraftUse of stickers/labels to apply coding Complete Complete DraftTransition requirements Complete Complete Under ApprovalEncoded data order Complete Draft DraftApplication identifier use Complete Draft Not StartedPrinted format of the 2D Data Matrix Complete Draft Not Started
![Page 16: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/16.jpg)
J&J Supply Chain ExperienceGerman securPharm Pilot - pharmacy point of dispense verification
• Approximately 400 pharmacies• Partnership between pharmacies and
manufacturers• Receive scan confirmation
J&JSupplyChain
101
![Page 17: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/17.jpg)
• GS1 standards based • Digital thread connecting
stakeholders• Embedding uniqueness into
business events• Building digital foundation for
IoT, Blockchain, etc.• Enabling real-time decisions• Bridging supply chain platforms
Serialization is Data Driven
102
![Page 18: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/18.jpg)
Collaboration Identifies Additional Business Value Opportunities
• Strengthens supply chain integrity
• Higher fidelity visibility enables efficiency improvements- Reducing counts and checks
- Reducing claims and credits
- Enhancing returns verification
• Communal standardizing of “best practices”
103
![Page 19: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/19.jpg)
Serialization Data Driven Insights Emerging in Manufacturing MAKE and PLAN
• Manual work reduction• Deviation investigation • Product issue resolution• Connecting plant to shelf – Digital
Thread• Unlocking visibility further into
supply chain• Real product flow and movement• Creating “win-win” for suppliers
and customers
104
![Page 20: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/20.jpg)
Healthcare Commercial Use Cases will Benefit as Well• Pricing and reimbursement
• Pharmacovigilance
• Pharmacoeconomics
• Indication-based pricing
• Patient compliance
UseData Wisely
105
![Page 21: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/21.jpg)
Our Actions on Serialization and Track & TraceSecuring the supply chain and driving end-to-end innovation
106
• 3500+ SKUs in scope
• End-to-end impact
• Customer collaboration and joint value creation
• Recognized by Council for Supply Chain Management Professionals with their 2016 Innovation Award
![Page 22: European Union (EU) Falsified Medicines Directive · Manufacturing MAKE and PLAN • Manual work reduction • Deviation investigation • Product issue resolution • Connecting](https://reader033.fdocuments.us/reader033/viewer/2022050103/5f426ca117b60e49201248dd/html5/thumbnails/22.jpg)
7 Billion Reasons to Care
107
Serialization and Traceability Will Benefit Patients and Consumers Everywhere