THE UNIVERSE OF LABELLING

Focus on Track & Trace

IMA Life Marketing

January 2017
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS
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 PREFACE – COUNTERFEIT DRUGS

The World Health Organization estimates that up to 1 per cent of medicines available in the developed
world are likely to be fraudulent.
This figure rises to 10 per cent in various developing countries, and in parts of Asia, Africa and Latin
America, fraudulent pharmaceuticals amount to as much as 30 per cent of the market.
In 2011, 64% of antimalarial drugs in Nigeria were found to be counterfeit.

According to the US Food and Drug Administration (FDA) and the different reports and consultants to
WHO, the value of the counterfeit drug market annually is $ 75billion. Moreover, 50% of the drugs
sold on the internet are believed to be falsified.

Industry analysts have estimated that counterfeit drugs cost pharmaceutical companies an estimated
$ 46 billion annually. The number of FDA counterfeit investigations has increased by almost 10-fold
since 2000.

PSI (Pharmaceutical Security Institute) data, show that the total number of pharmaceutical crime
incidents in 2011 was 1986, rising to 3002 in 2015.
In 2015, INTERPOL coordinated the “Operation Pangea VIII”, the largest ever Internet-based
operation focusing on the illicit sale of medicines and medical devices via the Internet, which saw a
record number of 20.7 million illicit and counterfeit medicines seized – more than twice the amount
confiscated during the 2013 operation.

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 PREFACE - THE FDA GUIDELINES

In the United States, the Drug Quality and Security Act of 2013 (DQSA) was signed into law last
November 2013. It includes, under Title II, the “Drug Supply Chain Security Act (DSCSA), which
establishes the new federal requirements for traceability.

The law requires FDA to develop standards, guidance documents, and pilot programs and to conduct
public meetings, in addition to other efforts necessary to support efficient and effective
implementation. FDA is developing a schedule for implementing the law’s requirements.

This system will enhance the FDA’s ability to help protect consumers from exposure to drugs that
may be counterfeit, stolen, contaminated, or otherwise harmful. The system will improve detection
and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers

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 PREFACE - THE FDA GUIDELINES
The development of the system will be phased in with new requirements over a 10-year period. These
requirements will include providing product and transaction information at each sale with lot level
information, in paper or electronic format, and placing unique product identifiers on individual drug
packages.

• Trade with authorized trading partners

• Provide transaction information to trading partners
• Quarantine and investigate suspect products
• Identify and remove illegitimate products and • Participate in electronic package-level
notify FDA and trading partners traceability system
2015 2023

15 2016
16 17 18 19 20 21 22 23

2017
• Serialize with unique product identifier
• Provide transaction information to trading partners in e-format
• Respond to verification requests from trading partners
• Verify unique product identifier of suspended products at
package level
• Verify the unique product identifier of returned products
intended for resale

So far, the FDA released:

• June 2014: draft guidance to handle the identification and notification of a suspect product.
• November 2014: draft guidance on how to exchange product tracing information.
• December 2014: guidance for product tracing requirements

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 PREFACE - THE FDA GUIDELINES

For a track, trace and authentication program to be truly successful the solution must offer
visibility and protection from the point of manufacture to sale to the consumer. The ideal solution will
not only ensure the identity, strength and purity of the drug but also the quality and efficacy.

Comprehensive track, trace and authentication solutions will ultimately reduce patient risk by giving
manufacturers, wholesalers, carriers, pharmacies and regulators a systematic method to detect and
control counterfeiting, drug diversions and product mishandling.

The solutions will ultimately ensure the right product, in the right place, at the right time, in
the right condition.

The serialization of pharmaceuticals is indeed a topical and pressing theme on the pharmaceutical
market. Pharmaceutical manufacturers are seeking simpler, more effective, and affordable ways to
combat counterfeit drugs, protect patient safety, and comply with the new and emerging regulations.
Increasing security measures helps protect patients, intellectual property, company reputation and
revenues.

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 PREFACE – GS1

Appropriate international commission (GS1) has defined standard codifications common for Mass
Serialization; standards recommend the use of Global Trade Item Number (GTIN) for the
identification of pharmaceutical products and Serial Shipping Container Code (SSCC) for logistic
cases identification.

GS1 is a neutral, not-for-profit organisation dedicated to the design and implementation of global
standards, technologies and solutions to improve the efficiency of supply by adding useful
information.
The GS1 Traceability Standard defines business rules and minumum requirements to be
followed when designing and implementing a traceability system.

The GTIN can be used on all layers of the

packaging from the primary pack, e.g. blister
through to the pallet.

Pharmacies and hospitals are increasingly

wanting ID codes on the unit dose and this will
become more common.

Global manufacturers want to use the same

method of identification (GTIN) across all
packaging layers and it will be less confusing
for health care providers.

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 PREFACE – THE EFPIA GUIDELINES

European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the

European Commission proposal on falsified medicinal products as an important starting point
for measures to tackle the problem of counterfeit medicins in the legitimate supply chain.

EFPIA strongly recommends a common coding system across Europe, with RFID as a possible
long term solution, but its technology together with its high costs make it difficult for it to be
implemented.

According to EFPIA, after the positive results of the pilot in Sweden (Sept. 2009 – Feb. 2010),
a 2D matrix barcode (called «data matrix ECC 200»), can be implemented in a step-by-step
approach (from a batch level to a product level), without requiring a radical change in
European coding system, harmonizing it instead.

EFPIA’s recommendations for coding of pharmaceutical products in Europe:

• Data matrix – Coding proposal derived from GS1 standards

- Manufacturer Product Code (GTIN or NTIN): 14 digits
- Unique Serial Number (randomized): up to 20 alpha-numeric characters
- Expiry date: 6 digits
- Batch Number: up to 20 alpha-numeric characters

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 THE EU DIRECTIVE
Hospital
According to the latest EU Directives
(2001/83/EC, 2010/84/EU and 2011/62/EU),
Track & Trace is to be adopted throughout the
whole supply chain of pharmaceutical products.
2 January 2013 is the deadline for member
States to bring into force the laws, regulations
and administrative provisions necessary to
comply with these Directives. Safety Features
are to be implemented within 36 months after
Delegated Act. * Retailer
Wholesale

Production

Pharmacy
Raw &
packaging
material

* A linear bar code is currently used in Belgium, Greece

and Italy as a carrier for the serialization number of
medicinal products: here the Directive foresees a 3
years more for the implementation of the safety
features.
THE TECHNOLOGY

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 THE TECHNOLOGY

Currently, two distinct technologies have been

developed to face this problem: Mass
Serialization and ePedigree, which recall a
simpler formula called "Track and Trace".
Barcode 2D Code

Information capacity About 20 characters About 4,000 characters

Most of Pharmaceutical companies identify Kind of information Alphanumeric figure Alphanumeric figure, Kanji
Mass Serialization with Data Matrix ECC200 Error correction function X
codes (2D) on unit pack level as the best, Readability Fixed position 360 °
cheapest and easiest method, together with a Cycle time to apply code (by laser) Seconds Milliseconds
database system accessed by all relevant
parties in the supply to verify the integrated
serial number.
Data Matrix Code is a 2D barcode symbology

Contains no data
providing high data density with error
correction (ECC200).

Contains data
The code is printed on the product and
subsequently read by vision and control
systems, which are produced by numerous
worldwide specialists, such as Sea Vision,
Systech, PCE and so forth. Contains
Contains
data data

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 THE TECHNOLOGY

Generally speaking, measures have already been taken to activate traceability solutions,
called Track & Trace, to complete and check the process of the pharmaceutical
production chain, and specifically:

-Installation of a 2D code marking system (DataMatrixECC200) in every packaging

line. This system must be capable of operating in real time.

-Installation of a Vision System in all packaging lines to verify, in real time, whether
the 2D code is correct or not.

-Installation of a software operating system, in all packaging lines, capable of

procuring, managing and storing the 2D codes that identify the packages (cartons).

-Installation of a centralized system to manage the 2D codes, capable of collecting

and managing data from all the production lines and making them usable for wholesalers
and/or pharmaceutical labs.

-Installation of a 2D code verification system for all packages that certifies the
authenticity of the package. This system will be installed at the wholesalers' facility
and/or at the pharmaceutical labs.

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 WORLD MARKET: STATUS QUO &
FUTURE SCENARIO

In many countries around the world, governments are working to approve specific local laws on
this aspect. Despite a unique solution effective world-wide is not feasable yet, pharmaceutical
industries, effected by huge economic losses caused by the counterfeit drugs’ market, keep
looking for measures easy to be implemented, with a low economic impact. The most critical
topics are the disagreement on the system to be adopted and who is going to pay for it.

For instance, the coding solution provides an efficient and cost effective method which meets
also the EC’s requirements for pack identification put forth in the recently adopted Falsified
Medicines Directive (July 2011).

As matter of fact, the ongoing EFPIA’s initiative to set up an effective safeguard system against
the entry of counterfeit medicines in the legal supply chain, clearly demonstrate that the
European industry is calling for:
- a harmonized coding and serialization system across Europe for greater patient safety;
- a stakeholder governed point-of-dispense system for cost-effectiveness;
- a 2D Matrix code on international standard as unique identifier for interoperability.

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 FOCUS ON: USA

• November 2013: the Drug Quality and Security Act

was signed into law.
• January 2015: Companies must provide
Transaction Documents (TD) identifying items using
the U.S. National Drug Code (NDC) and packaging
lot and quantity, in either paper or electronic form,
and maintain the documents for a minimum 6 years.
• November 2017: manufacturers must imprint
human interpretable as well as a DataMatrix symbol
containing a unique Standardized Numeric Identifier
(SNI), the packaging LOT number, and the expiration
date on each package. For the case, they must apply
a linear of DataMatrix code containing a unique FDA
SNI, the packaging LOT number, and the expiration
date. Transaction documents and history in
electronic form have to be maintained for 6 years.
• November 2018: manufacturers’ encoding rules
extended to repackagers, too.
• November 2023: companies will no longer need to
pass on to their customer’s transaction histories all
the way back to the original manufacturer. They will
only need to include information about where they
bought the drug, the so-called “one-up, one-down”
sharing system (previously full supply chain history).

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 FOCUS ON: BRAZIL

• December 2013: entered into force the Resolution

No. 54 by the Joint Board of the National Health
Surveillance Agency (ANVISA) that established rules
and provisions for implementation of a national
system of drug product identification and tracking.

• December 2015: manufacturers and importers

have to test their capabilities and provide data from
three separate LOTs.

• December 2016: each sealable package and

bundles (shelf packs) have to be encoded with the
Brazilian Unique Medicine Identifier (IUM). The law
requires the collection of trade data, including
ANVISA Drug Registry Number, Serial number,
expiration date, packaging LOT number in human
readable form, and DataMatrix symbol. Shipper
cases must have a unique identifier (not UDI).
Manufacturers and importers have to track and
maintain the IUM as well as the CNPJ (Cadasto
Nacional de Pessoas Jurídicas) business registration
number of the shipping and receiving companies,
date and type of transaction.
GS1 standards support the encoding of the IUM as
application identifier for country reimbursement.

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 FOCUS ON: ARGENTINA

• 2012: The law requires serialization and tracking using GS1 encoded DataMatrix symbols for
all unit-level items that are reimbursed.
Manufacturers have to imprint the item’s identity using a GS1 GTIN, a unique serial number,
the packaging LOT number, and expiration date both in human readable form and a machine
readable GS1-encoded DataMatrix symbol.

• 2013: the Argentine authority tasked with combating illegal narcotics, SEDRONAR, launched
a national chemical precursors traceability system to enable operators to digitally record
precursor transactions nationwide via a computer network.

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 FOCUS ON: CHINA

• April 2008: China’s SFDA (State Food and Drug Administration) calls for serialization on
individual saleable pharmaceutical products by December 2011 for 275 therapeutic areas (for
drugs sold in the Chinese market as well as the ones manufactured in China).

• May 2013: China’s Ministry of Health released the essential drug list (EDL) of product
requiring serialization expanding the original list to 502 products (including traditional drug
products and holistic Chinese remedies).

• March 2015: Full implementation of the system to track movement of goods from
manufacturer, through each storage of the supply chain, to dispensing and final recipient.

Sealable items (primary and secondary packages up to the pallet) are encoded with a linear
ISO-128 barcode containing a 20-digit code comprised of the Chinese National Drug Code
(NDC), serial number and check digits.

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 FOCUS ON: SOUTH KOREA

2011: according to the notification 2011-58 of the Ministry of Health and Welfare, pharmaceutical
barcode or RFID tags must be adhered to primary, secondary and external containers (shipping cases)
as well as each sealable item.

January 2015: all packages must include the item’s identity as a GTIN (unique serial number for each
item), packaging LOT, and expiration date in human readable form and a DataMatrix symbol.

Manufacturer must include a barcode or RFID tag on distributed drugs that are domestically
manufactured or imported.
Cases must include the same information in linear, GS1-128 barcodes.

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 FOCUS ON: INDIA

2015: Products exported to countries without

drug traceability require serialization.

The Indian Directorate General of Foreing Trade

(DGFT) requires GS1-GTIN, serialization and
barcode on tertiary (cases), secondary and
primary packaging for all pharmaceuticals
exported. The law requires GS1 DataMatrix
symbols on drugs at the unit of sale as well as
encoding GTIN and unique serial numbers.

Exported items requiring serialization: GS1-

GTIN code, unique serial number, packaging lot
and expiration date. Sealable units include
DataMatrix symbol and cases include a linear
GS1-128 barcode.

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 FOCUS ON: JORDAN

January 2017: all prescription drugs must contain both

human readable text, and a DataMatrix symbol encoded
with GS1 GTIN to identify the item, the packaging LOT
number, expiration date and pack size.

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 FOCUS ON: SAUDI ARABIA

March 2015: the outer package of prescription

drug products must contain both a human
readable, and a DataMatrix symbol encoded
with GS1 GTIN to identify the item, the
packaging LOT number, expiration date and
pack size.

March 2017: each prescription drug item must

contain a unique serial number with the
information listed above and the number must
be encoded in the DataMatirx symbol.

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 FOCUS ON: TURKEY

2012: the Turkish Ministry of Health (MOH) etablished the

ITS (Pharmaceutical Track and Trace System) to track
prescription drugs and their shipping cases.

The law requires serialization and tracking using GS1

encoded DataMatrix symbols for all unit-level items
reimbursed by MOH.
Manufacturers have to imprint the item’s identity using a
GS1 GTIN, a unique serial number, the packaging LOT
number, and expiration date.

Information is posted into the ITS database by

manufacturer, and as goods move through the supply
chain.

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 FOCUS ON: FRANCE

AFSSAPS regulation (2011):

• All pharmaceutical products distributed in France

must have a 2D Data matrix barcode,
incorporating the CIP13 code (product number),
batch number and expiration date at item level.

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 FOCUS ON: ITALY

• 2001: application of the Italian bollino (AIC code – 9 digits), supplied by an authorized
printer designated by the Italian government.
- Unique sequential code.
- Product name, ID #, Holder name.

• 2005: Italian MoH established a central database to track pharmaceutical products.

• 2007 IMPACT ITALIA: Italian task-force that involves the main institutions working to
combat counterfeit medicines.

• 2015: UDI (Unique Device Identification) regulation under development.

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 THE IMA LIFE OFFER

IMA Life is actively engaged in tackling the threats of counterfeits and ready to cope with all the
different needs of its Clientele on the international market. Several solutions have already been
developed and installed to align the pharmaceutical drug packaging lines to the new emerging
requirements in terms of track and tracing, and ad hoc solutions have been tailored to existing or
new packaging lines.

The request that Clients make most often is that of printing the 2D code to the labels on line, and
this is why IMA Life has come up with different solutions for the Track & Trace process.