global traceability regulations a snapshot - · pdf fileglobal traceability regulations a...

Global Traceability yRegulations

A Snapshot

© 2013 Axway | Confidential 1© 2013 Axway | Confidential 1

Agenda

• Plethora of global Pharma traceability regulations

• Common models

• Brazil example

• Implicationsp

© 2013 Axway | Confidential 2

Pharma - Europedi & i li ti i tcoding & serialisation requirements

Denmark 2011 Product Code

Europe 2018

Cyprus 2010 Product Code

Slovenia 2015 Product code &

France 2011 Batch Variable

Europe 2018 Compliance to Falsified

Medicines Directive(FMD) Europe Q4 2014 Delegated acts finalised

Batch/Expiry date

2010 2011 2012 2013 2014 2015 2016 2017 2018

Turkey 2010 Track & Trace

Europe 2011 Denmark 2014

Ukraine 2017Serialisation

England/NHS 2014 GTIN, GLN and

European Legislation

Serbia 2010 Traceability regulation

AMGROS : DataMatrix or bar code on injection & infusion

,product data

© 2014 GS1 © Copyright GS1 AISBL, 2014. All Rights Reserved.

Regulated requirementTender requirementImportant developmentEmerging Regulatory requirements

EU – 2011, 2014, 2018Falsified Medicine Directi e (FMD)Falsified Medicine Directive (FMD)

Status: Directive 2011/62/EU on prevention of the entry into the legal supply chain of falsified medicinal products Scope: Pharmaceuticals (incl vaccines)Scope: Pharmaceuticals (incl. vaccines)Purpose: Counterfeiting

Requirements as applicable: – AIDCAIDC– Packaging level: secondary level packaging– Data elements: Unique identification number, Batch/Lot number, Expiry date, Serial number,

national reimbursement number (if applicable)– Data carrier: DataMatrixData carrier: DataMatrix– Deadlines:

– 2011: Adoption of a new Directive on falsified medicines (FMD)– 2014: Delegated Acts to provide more detailed requirements on this capability

2018: requirements implementation in all EU Member States– 2018: requirements implementation in all EU Member States– Data Submission Portal: Stakeholder model– Traceability Model: Authentication model

Open point(s)/upcoming dev : EU Delegated Acts on safety features should be adopted end 2014/early

© 2014 GS1

Open point(s)/upcoming dev.: EU Delegated Acts on safety features should be adopted end 2014/early 2015.PP Database Dossier #: 200EUPH053011

4

Pharma – World (except Europe)di & i li ti i t

Jordan 2017 S i li ti

coding & serialisation requirementsCanada 2012 Vx Batch Variable

Korea 2013 Batch VariableEthical drugs

Argentina 2012Serialisation 2nd product group

India July 2014Serialisation for export – 1st level

Saudi Arabia 2015 DataMatrix Saudi Arabia 2017

Serialisation

Argentina 2011 Serialisation

Korea 2015 Serialisation

China 2015 Serialisation Phase III (all products)

India Jan. 2013Serialisation for export - 2nd

level

Argentina 20111st product group

Argentina 2013Serialisation 3rd product group

Brazil 2016ANVISA Track & Trace regulation ( all pharmaceuticals)

China 2012 Serialisation Phase I

2010 2011 2012 2013 2014 2015 2016 2017

Nigeria

…

USA 2010 FDA SNI guidance

India 2012 Identification for tender requirements

Taiwan2015/2016Draft Regulation Barcode req. -

Brazil 2015ANVISA Track & Trace regulation (3 batches of product)

Nigeria March 2013 MAS all antibioticsl

USA 2017 DSCSA - Serialisedproduct identifiers

Singapore 2014 Barcoding on injectableFDA SNI guidance

India 2011Serialisationfor export – 3rd level Korea 2012

Batch Variable Specified drugs

Nigeria Jan 2013 MAS all anti-malarial

Mexico 2014Draft Regulation on traceability

Japan 2015 Barcoding primary level

USA 2015 DSCSA -Product TracingRequirements(lot/batch & exp) USA 2023

DSCSA - Pkg (item-level) traceability

j

China 2013 Serialisation Phase II

© 2014 GS1

Japan 2012 Revised MHLWBarcode Guidelines

Regulated requirementTender requirementImportant developmentEmerging Regulatory requirements

anti malarial on traceability

Libya: serialisation – timeline to be defined

© Copyright GS1 AISBL, 2014. All Rights Reserved.

Chile 2013Identification & traceability

South Africa: traceability – timeline to be defined

Algeria: serialisation – timeline to be defined

JS4

JS4 TaniaJuliana Schubert, 4/10/2014

Pharma – World (including Europe)coding & serialisation requirementsg q

Cyprus 2010 Product Code

USA 2010

Denmark 2011 Product Code

Argentina 2011

Canada 2012 Vx Batch Variable

Argentina 2012Serialisation 2nd

Korea 2013 Batch VariableEthical drugs

India July 2014Serialisation for export – 1st level

Slovenia 2015 Product code & Batch/Expiry date

Saudi Arabia 2015 DataMatrix

Brazil 2016

Saudi Arabia 2017 Serialisation

Jordan 2017 S i li ti

China 2012Serialisation Phase I

USA 2010 FDA SNI guidance

France 2011 Batch Variable

1st product groupSerialisation 2nd product group

India Jan. 2013Serialisation for export - 2nd level Argentina 2013

Serialisation 3rd product group

Europe Q4 2014 Delegated actsfinalised

Korea 2015 Serialisation

China 2015 Serialisation Phase III (all products)

Brazil 2016ANVISA Track & Trace regulation (all pharmaceuticals)

Serialisation

Europe 2018 Compliance to FMD

2010 2011 2012 2013 2014 2015 2016 2017 …2018

England/NHS

Turkey 2010 Track & Trace

Serbia 2010 Traceability regulation

Europe 2011

India 2012 Identification for tender requirements Chile 2013

Identification & traceability

Denmark 2014AMGROS: DataMatrixor bar code

g2014

GTIN, GLN and product

data

Taiwan2015/2016Draft Regulation Barcode req

Japan 2015 Barcoding primary level

USA 2015 DSCSA -P d t T i

Ukraine 2017Serialisation

USA 2017 DSCSA - Serialisedproduct identifiers

Europe 2011 European Legislation

India 2011Serialisation

for export – 3rd level

Korea 2012 Batch Variable Specified drugs

Japan 2012 Revised MHLWBarcode Guidelines

Nigeria 2013 MAS all anti-malarial / MAS all antibiotics

Mexico 2014Draft Regulation on traceability

Singapore 2014 Barcoding on

injectable

Barcode req. -Product TracingRequirements(lot/batch/exp)

USA 2023 DSCSA - Pkg (item-level)

traceabilityBrazil 2015ANVISA Track & Trace regulation (3 batches of product)

© 2014 GS1

Regulated requirementTender requirementImportant developmentEmerging Regulatory req.

© Copyright GS1 AISBL, 2014. All Rights Reserved.

Libya: serialisation – timeline to be defined

South Africa: traceability – timeline to be defined

Barcode Guidelines y

China 2013Serialisation Phase IIAlgeria: serialisation – timeline to be defined

Medical devicesdi d d t b i tcoding and database requirements

Turkey 2009

USA Q3 2014FDA UDI ImplementationClass 3

USA 2018

Cyprus 2010 product code tender Guidance

Netherlands/NVZ 2012 Product code

Belgium 2013 Argentina 2014Turkey 2009 Product code & database

GHTF 2011UDI Guidance

EU – April 2013EC UDI Recommandation

USA 2018FDA UDI ImplementationClass 1EU Q3 2012

EC proposalMD Regulation

USA 2015FDA UDI ImplementationLife supporting/sustaining devices

Law on MDTreacability

Traceability System of Medical Devices – first products

2009 2010 2011 2012 2013 2014 2015 2016 2018

Argentina 2015

USA Q4 2012 Comments on draft FDA UDI

USA Q3 2013Final FDA UDI

USA 2016 FDA UDI ImplementationClass 2

Spain - 2009 SAS product code

Japan Q1 2011 Product code & variable –Rest

USA Q3 2012 EU Q2 2014/Q1 2015

England/NHS 2014 GTIN, GLN and product data

Argentina 2015Traceability System of Medical Devices – more products

RegulationJapan Q1 2009 Product code & variable Phase 1

Japan Q1 2010 Product code & variable – Phase 2

England/NHS 2012 Product code

Draft FDA UDI Regulation

Q2 2014/Q1 2015MD Regulation

IMDRF 2013UDI Roadmap

© 2014 GS1

Canada, China, Spain, Korea, India, Japan , Brazil, etc.: UDI regulatory requirements under dev.

Regulated requirement

Tender requirement

Important development© Copyright GS1 AISBL, 2014. All Rights Reserved.

USA

© 2014 GS1

DSCSA TimelinesDSCSA TimelinesManufacturers, repackagers,

wholesalers must exchange lot-level TI, TH, TS for 100% of shipments

1/1/2015

6/1/2015

Dispensers must receive lot-level

TI, TH, TS11/27/2023

Unit-level traceability for entire US supply-chain

11/27/2017

Manufacturers required to send electronically

2014 2015 2016 2017 2018 2019 2020 2021 2023

1/1/2015

• Verify transaction data at unit level

Manufactures:• Serialize 100% of units +homogeneous cases

11/27/2017

11/27/2018 11/27/20201/1/2015Supply-chain must have

systems and processes in place to verify transaction

data at lot-level• Verify transaction data at unit level

Repackagers:• Buy/sell only serialized products

11/27/2018

Wh l l11/27/2019


Dispensers:• Buy only serialized products



Wholesalers:• Buy/sell only serialized productsLot Traceability

Serialization

4 Core Areas of DSCSA4 Core Areas of DSCSAProduct Tracing Serialization Verification Request for

Information

•Single document which includes transaction information, transaction statement, d i hi

•Apply a Standardized Numeric Identifier (SNI) to uniquely identify a package or

l d h

•Determining whether the product identifier affixed to, or imprinted upon, a package or h

•Must respond within 1‐2 business days to a request for TI, TH, TS in the event of suspect or ill i i dand transaction history

•Provisions for both lot and unit level tracing

sealed homogeneous case.

•Must not buy or sell unless product is serialized

homogeneous case corresponds to t the standardized numerical identifier or lot number and expiration d t

illegitimate product•Must respond within 24 hours to a request for information at a unit level – coincides

•Rolling timelines starting November 27th, 2017

date• Systems and processes to validate TI, TH, TS for product in possession.

with serialization timelines

• Lot verification starts January 1st, 2015

•Unit‐level verification coincides with serialization timelines


se a at o t e es

TI/TH/TS DefinitionsTransaction Information •The proprietary or established name or names of the product

• The strength and dosage form of the product• The National Drug Code number of the product• The container size• The number of containers• The lot number of the product• The date of the transaction• The date of the shipment, if more than 24 hours after the date of the transaction• The business name and address of the person from whom ownership is beingThe business name and address of the person from whom ownership is being transferred;• The business name and address of the person to whom ownership is being transferred.

Transaction History A statement in paper or electronic form, including the transaction information forTransaction History A statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

Transaction Statement A statement, in paper or electronic form, that the entity transferring ownership in a transaction—• Is authorized as required under the DQSA• Received the product from a person that is authorized as required under the DQSA• Received transaction information and a transaction statement from the prior owner of the product• Did not knowingly ship a suspect or illegitimate product• Had systems and processes in place to comply with verification requirements


• Had systems and processes in place to comply with verification requirements • Did not knowingly provide false transaction information• Did not knowingly alter the transaction history

5 Key Strategies for Interoperability5 Key Strategies for Interoperability

2. Document Pedigree 5 FDA Interoperability1. Paper / Portal

• Minimal impact to existing systems and processesLik l b

Messaging Standard (DPMS)

• Purpose built EPCGlobalstandard to meet existing state pedigree laws • Mature supply‐chain use‐

3. HDMA ASN

• Released Q2 2014 on HDMA website• Modified version of ANSI X12 ASN 856

4. EPCIS 1.1/CBV

•Released Q2 2014• Axway is involved in GS1 working groups• Outlines lot level

5. FDA Interoperability Guidance

•Released no later than November 27th, 2014•May 8th, 9th FDA Public Workshops• Likely occur by

modifying packing slip or providing a customer portal

• Mature supply‐chain use‐cases•A number of supply‐chain participants have invested in DPMS compatible systems

X12 ASN 856•Transaction histories and master data replication hurdles• Expect revision to be released any day

• Outlines lot‐level traceability using EPCIS transactions• GS1 US Healthcare Guidance will align standard with DSCSA.

Workshops•Current RFI docket open for public comment until June 9th, 2014•Not expected to endorse a single interoperability format

Key Considerations:di ’

Key Considerations:Will di

Key Considerations:R l i l h i

Key Considerations:Mi ti th f l t

Key Considerations:C i i• Trading partner’s

infrastructure capabilities• Paper will exist in supply‐chain on January 1st, 2015

• Will your trading partners accept DPMS?• Maturity of supply‐chain use‐cases

• Role in supply‐chain• Migration path from lot traceability to item level serialization• Data storage

•Migration path from lot traceability to item level serialization• Global compliance strategy• Aggregation / InferenceO i i t f

• Companies can not wait for guidance to start implementation• Be involved.


• On‐going maintenance of standard

Compliance Models

© 2014 GS1

Typical Labeling Requirements A t t d Id tifi ti / D t C t T h l (AIDC)• Automated Identification / Data Capture Technology (AIDC)

• Packaging level: – Tertiary (Pallet; Case/Carton);– Tertiary (Pallet; Case/Carton); – Secondary (common marketing pack), – Primary (dispensing item – e.g. one blister in a box of 4) y ( g g )

• Data elements: – Product Code / GTIN– National Healthcare Reimbursement Number (NHRN)– Expiration Date

B t h/L t N b– Batch/Lot Number – Serial Number - by Regulatory Body or Manufacturer

• Data carrier: EAN/UPC GS1-128 DataMatrix; RFID


Data carrier: EAN/UPC, GS1 128, DataMatrix; RFID

Traceability Models Central Government Repository e.g. China

Pharmacy / Dispenser

Contract Manufacturer

Wholesaler

Manufacturer3PL

Standard Numerical Id Verification

Serial Numbers

Transaction History


Government Regulatory Body

Government mandatedCommercial/Logistics

Traceability Model Regulated Supply Chain (Stakeholder Model) – e.g. USA


g pp y ( ) g


Wholesaler Pharmacy / Dispenser

T i

Transaction History

Manufacturer

Dispenser

Serial NumbersTransaction History

Transaction History

3PLTransaction History



Government regulatedCommercial/Logistics Govt Requests

Traceability Model Book End (EU)


( )

Standard


Pharmacy /


Serial Numbers

Wholesaler

y /Dispenser

Manufacturer3PL3PL

Serial Numbers


Government regulatedCommercial/Logistics

Serialized Traceability Snapshot - EvolvingCountry Package

L lSerial N b B

Transaction Recording / R ti

Year in EffLevel Numbers By… / Reporting Effect

India 1st Manufacturer To define 2014 (?)

China 2nd Government Report to Govt 2012 2015China 2nd Government Report to Govt 2012‐2015

USA 2nd Manufacturer Pass to Buyer; Store 2015‐2023

Brazil 2nd / 3rd Manufacturer Accessible to Govt 2015‐2016Brazil 2 / 3 Manufacturer Accessible to Govt 2015 2016

EU 2nd Manufacturer Serial Numbers to Central Database

2018

Turkey 2nd Manufacturer Report to Govt 2010

Argentina 2nd Manufacturer Report to Govt 2013

South Korea 2nd Manufacturer Under discussion 2015

Ukraine 2nd Manufacturer Report to Govt 2017

J d 2 d T d fi T d fi 2017


Jordan 2nd To define To define 2017

Saudia Arabia 2nd To define Stakeholder 2017

Brazil


ANVISA UpdateANVISA Update

• December 10th, 2013– Passed RESOLUTION RDC N. º 54 outlining new requirements for

unit-level traceability.– Defined timelines for implementation– Defined high-level initial architecture

• February 17th, 2014– ANVISA establishes Steering Committee on Drug Control System – Representatives from government, professional health care advice,

industry representatives and organizations of different areas of the medical sciencesmedical sciences

• Next StepsANVISA to define interoperability standards for remote access


– ANVISA to define interoperability standards for remote access interface to government

Definitions (1/2)Term DefinitionTerm Definition

Drug Product Tracking

Set of procedures that allow background information tracing, application or localization of drugs, by means of previously recorded information, through an exclusive product identification system, to be applied for the control of

Tracking all and every drug product unit produced, dispensed or sold in national territory.

Drug Product ChainPharmaceutical product flowchart from the source to the consumption, comprising the following stages: production, importation, distribution, g

(Business Step)co p s g t e o o g stages: p oduct o , po tat o , d st but o ,transportation, storage and dispensing, as well as other types of movement foreseen by the sanitary controls.

MovementAll transactions regarding the displacement of drug product units between establishments throughout the pharmaceutical production chain theMovement establishments throughout the pharmaceutical production chain, the dispensing, as well as returns and recalls of already dispensed products.

Movement Nature(Business Step)

Purpose of the movement, such as sales, donation, transferences, returns, recalls, disposals, losses, among others.( p)

Exclusive ProductIdentification(Serialization)

Attribution of the Drug Product Single Identification (IUM) code, corresponding to the smallest commercializing unit, according to the established herein.


Outsourcers Producing companies/manufacturers, wholesalers, retailers, importers; transporters, buyers, dispensing units and drug product prescribers.

Source: Interfarma English translation of RESOLUTION RDC N. º 54, DECEMBER 10th, 2013

Definitions (2/2)Term Definition

A series of numeric, alphanumeric or special characters created through identification and codification standards, which allow the exclusive and unmistakable identification of each specific unit of drug product commercialized in the market according to the disposed herein

Drug Product Single Identification (IUM) code

commercialized in the market, according to the disposed herein.

IUM Data Elements:

• Drug product Anvisa registration number containing 13 (thirteen) digits• Drug product Anvisa registration number, containing 13 (thirteen) digits• Serial Number• Expiry date, format: MM/YY and• Batch number

Serial Number

Individual non‐repetitive 13‐digit number in the IUM, corresponding to each drug unit to be commercialized in the Brazilian territory, establishing the two‐dimensional barcode and written in a way that is readable to the human eye on the commercial package, according to the disposed herein.

Transportation packagePackage used for the transportation of drug products placed in its primary or secondary packages.

Drug Product Control Corporate repository to store product traceability data


gNational System (SNCM)

Controlled Product National System (SNGPC)

An interface allowing Brazilian Sanitary Surveillance Agency to retrieve data from corporate repository.

Brazil RequirementsR l R iRegulatory RequirementTraceability Model Unit‐level traceability of physical movement of product.

Government and trading partner external reporting.

Supply‐Chain Participants Producing companies/manufacturers, wholesalers, retailers, importers, transporters,Supply Chain Participants Effected

Producing companies/manufacturers, wholesalers, retailers, importers, transporters, buyers, dispensing units and drug product prescribers.

Item level serialization Unique identifier across all products; Drug Product Single Identification (IUM).

Physical Data Carrier 2D DataMatrix

Tertiary Packaging SerializationYes, aggregation and inference required

Randomization Required Yes

E t l R ti E t l ti i i d b ll b f th l h iExternal Reporting External reporting is required by all members of the supply‐chain:

• Supply‐chain participants required to report back to the manufacturer• Manufacturer / brand owner is required to provide Brazilian Sanitary Surveillance Agency remote access to data.g y

Interoperability Format ANVISA to establish interoperability standards for remote access interface

Record Retention Must retain item‐level tracking data for 2 years after product expiration date

Implementation Dates


Implementation DatesDecember 10th, 2015 ‐ Three (3) batch/lots traced through supply‐chain and made available to the Brazilian Sanitary Surveillance AgencyDecember 10th, 2016 ‐ 100% of products serialized and tracked

ANVISA Proposed Architecture


What does it mean for a Global Pharma Organization?Pharma Organization?


Some Implications of Global Compliance

• Evolving regulations– Agile Architectureg

• Support multiple models and multiple legal rolesSerial number management– Serial number management

– Central / distributed repositories– Different obligations depending on the role

• Supply Chain and Government - InteroperabilityDi t h l d l l f hi ti ti– Diverse technology and level of sophistication

– Multiple standards


Phased ApproachPhased Approach

Now ‐Assessment

•Assess current

Phase 1 ‐

Lot Level Tracingl i

Phase 2 ‐

Serializationf l il

Phase 3 ‐

Unit‐Level Tracingf l il• Assess current

serialization project•Develop strategy with end‐state in mind

•Harmonize on GS1

• Implement enterprise platform which supports serialized and non‐serialized tracking

• Locate required

• Learn from early pilots with trading partners

•Develop enterprise serial number management strategy

• Learn from early pilots with trading partners

• Enable support for aggregation and inference

standards• Evaluate current infrastructure

• Evaluate partner capabilities

attributes in backend and partner systems

•Build‐out required interfaces to ERP, WMS, and partner systems

•Rollout and testing of manufacturing lines / CMO’s

•Rollout and testing of distribution center edge

•Enable traceability for returns

•Advanced exception handling

capabilities• Identify strategic business opps

p y•End‐to‐end testing with trading partners

distribution center edge systems / 3PL’s


global traceability regulations a snapshot - · pdf fileglobal traceability regulations a...

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