The Essential Guide

to Serialization in the EU

WHY SERIALIZE?

COUNTERFEIT MEDICINES HAVE BECOME A SERIOUS THREAT

TO PUBLIC HEALTH

10%

20x

700,000

$10bn

More profitable than trafficking Heroin(source : WHO)

Of medicines sold worldwide are counterfeit(source : WHO estimation)

Deaths per year (malaria & tubercolosis treatment only)(source : OECD)

Annual revenue loss for EU pharma industry(source : EUIPO)

WHY DO YOU NEED TO FIGHT AGAINST COUNTERFEIT DRUGS

BY USING A SERIALIZATION SOLUTION?

CREATE

NEW BUSINESS OPPORTUNITIES

PROTECT

YOUR CURRENT SALES

PRESERVE

YOUR BRAND IMAGE

INCREASE

PATIENT SAFETY

HOW TO SERIALIZE?

WHAT DOES SERIALIZATION MEAN FOR THE PHARMA

INDUSTRY

Serialization is the affixing of unique serial numbers

(Unique Product Identifier) to each saleable package

unit of product.

Aggregation is the linking of all package levels in a

Parent/Child Relationship (i.e. bundle, case, pallet)

Track & Trace: tracing a product all the way through

the supply chain to the end consumer or point of

dispensation

WHAT IS A UNIQUE PRODUCT IDENTIFIER?

A UPI is a standardized graphic that includes

Human-readable formMachine-readable data carrier

Examples:

+

UNIQUE IDENTIFICATION CODE (SGTIN)

(01) GTIN Code including name identification, common

name, dosage, size of the content and type of drugs

(17) Expiration

date

(10) Lot

number

National reimbursement number or other national

identification number requested by the destination

country.

(21) Serial number : Numeric or alphanumeric

series of numbers with max 20 digits , generated

by randomised or not algorithm.

SGTIN (Serial Global Trade

Item Number)(01) GTIN (21) Serial Number+

Unique identification code

=

2 3

UNIT LEVEL SERIALIZATION: THE SOLUTION AGAINST COUNTERFEITING IN TRADITIONAL DISTRIBUTION CHANNELS

REGULATORY

CONTROL

SUPPLY CHAIN

CONTROL

Unique combination code / history is impossible to replicate

1PACKAGING CONTROL

Serialization & Aggregation

Unique code number attribution / unit

PRODUCT ID

DATABASE

1 PRODUCT WITH 1 UNIQUE CODE NUMBER + 1 UNIQUE HISTORY

= RELIABLE TRACEABILITY

TWO LEVELS OF COMPLIANCE

ARE REQUIRED

Data

Management &

Exchange

≈ 100 BILLIONSProducts to be serialized

and tracked each year

Data Upload to a

Hub or Reporting

to Authorities

Packaging Line

Serialization

≈ 20,000Packaging lines to be equipped

….and limited serialization

solution providers capacities

Data

Carriers

REQUIREMENTS BY COUNTRY

ALREADY OBLIGATORY

DEADLINE

EXPECTED SERIALIZATION AGGREGATION DATAMATRIX

MORE THAN 40 REGULATIONS IN PLACE OR TO COME

BY 2021,85% OF PRESCRIPTION DRUGS WILL BE SERIALIZED

Serialize all prescription drugs at the unit of sale level compliant with requirements

set out in the Falsified Medicines Directive 2011/62/EU.

Use

tamper-evident packaging.

Report product master data & serialization data

to a European Hub

Report events

like recalls, decommissioning, recommissioning.

Relative flexibility of Directive 2011/62/EU allows

for country-specific requirements.

FMD REQUIREMENTS

TO MEET on FEBRUARY 2, 2019

Serialize all RX products

at the unit of sale level compliant with the FDA’s SNI guidance

Store the DSCSA information

for a minimum of 6 years

Serialize all RX products in

homogenous cases compliant with the FDA’s SNI guidance

Provide

the Transaction Statement, History, and Information in electronic format

Be prepared to report

against DSCSA data within 48 hours

DSCSA REQUIREMENTS

TO MEET on NOVEMBER 27, 2017 (*)

(*) The FDA postponed the DSCSA requirements

deadline to November, 28th, 2018

MAIN CHALLENGES

Timeliness: If you cannot achieve Serialization compliance in time, you put your whole business at

risk

Productivity: Central configuration and prequalification reduce impact on OEE and speed up

deployment

Connectivity: Serial numbers, master data and event information need to be exchanged among

supply chain parties and also reported in a compliant way.

Communication: Serialization implementation requires the coordination of numerous internal

and external stakeholders. Don’t underestimate the scope of your project!

Serialization and Beyond: when choosing your serialization solution, don’t forget to consider

future compliance and regulatory requirements. Beyond compliance, think of the business potential of

your serialization data.

SERIALIZATION REQUIREMENTS

MAIN CHALLENGES