PHARMACEUTICAL

SERIALIZATION
TRACK & TRACE
EASY GUIDE TO COUNTRY-
WISE MANDATES
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Table of Contents

Introduction 05

US Federal 06

California 08

Argentina 10

Brazil 12

South Korea 14

India 16

China 18

EU 20

France 22

Turkey 24

References 26

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External Document © 2018 Infosys Limited
Introduction
Pharmaceutical companies have to contend with challenges stemming from supply
chain security lapses (resulting in theft, diversion and product recalls), counterfeiting and
stringent regulations. In addition to alarming safety concerns, these challenges also impair
the health of the industry by adversely impacting profits, brand credibility and research
initiatives.

With both industry and governments around the world realizing the significance of
implementing product serialization, it becomes mandatory for all entities within the supply
chain to comply with federal and/or state legislations pertaining to the locations in which
they operate.

Typically, drug distribution systems consist of entities such as manufacturers, wholesale

distributors and pharmacies before products reach the end consumer. Ensuring secure
product track and trace capabilities across various touch points throughout the supply chain
- through product serialization implementation - is crucial to address the challenges faced
by the industry. Apart from providing visibility and full traceability within the supply chain,
successful serialization programs will prove to be a key differentiator and a clear competitive
advantage for pharmaceutical companies.

This guide, compiled by the Legal and Research team at the Infosys Life Sciences Center
of Excellence provides a summary of the legal and regulatory framework proposed by
countries including Argentina, Brazil, China, EU, France, India, South Korea, Turkey, and USA
(Federal and California) to maintain supply chain integrity and ensure patient safety. This
guide also provides information on mandates to be adhered to by various stakeholders, to
ensure regulatory compliance.

We look forward to further discussing this research with you.

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 US Federal
Drug Quality and Security Act - H.R. 3204
The Drug Quality and Security Act - H.R. 3204 was
introduced on September 27, 2013. This bill was passed
in the House on September 28, 2013 - also referred as
Pharma track and trace bill - is approved by Senate as a
US federal law effective Nov 27, 2013.

The Drug Quality and Security Act would address the

following two important issues affecting the quality and
security of America’s drug supply:

1. Protect traditional pharmacies and clarify laws

related to human drug compounding in response
to the nationwide meningitis outbreak – one of the
largest public health crises in recent times.

2. Strengthening of prescription drug supply chain

in order to defend American families against
counterfeit drugs and protect jobs.

The bill is supported by the National Community

Pharmacists Association, U.S. Chamber of Commerce,
UPS, PhRMA, GPhA, BIO, HDMA, HIDA, NACDS and many
other organizations.

Below is the detailed mandate requirements and their respective

timelines:

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Title 1 - Compounding Quality Act Title 2 - Drug Supply Chain Security Act
Title I of the Drug Quality and Security Title II of the Drug Quality and Security Act,
Act, which is based on Rep. Morgan which is based on Rep. Bob Latta’s (R-OH)
Griffith’s (R-VA) H.R. 3089 and the Energy H.R. 1919, would create a uniform national
and Commerce Committee’s investigation standard for drug supply chain security
of the meningitis outbreak (including to protect Americans against counterfeit
four committee hearings), would clarify drugs while eliminating needless
FDA’s authority over the compounding of government red tape. The bill also would
human drugs while requiring the agency help prevent increases in drug prices, avoid
to engage and coordinate with states to additional drug shortages and eliminate
ensure the safety of compounded drugs. hundreds of millions of dollars’ worth of
duplicative government regulations on
This bill would enable the following:
American drug manufacturers, wholesale
1. Preserve and protect the practice of distributors, pharmacies, repackagers
traditional pharmacy compounding and third-party logistic providers. The bill
occurring in community pharmacies. would:
2. Eliminate the unconstitutional This bill would enable the following:
provisions of Section 503A of the
1. Create a new framework for securing
Federal Food, Drug, and Cosmetic
our prescription drug supply chain.
Act (FFDCA) that created uncertainty
The bill also would establish a 10-
regarding the laws governing
year transition to a unit level tracking
compounding and require FDA to
system for enhanced security.
engage in two-way communication
with state regulators – a major 2. Eliminate the patchwork of red tape,
deficiency in FDA’s response to the like California’s pedigree law, on drug
meningitis outbreak. manufacturers, wholesale distributors,
pharmacies, repackagers, and third-
3. Permit entities engaged in the
party logistic providers (3PLs). These
compounding of sterile drugs to
changes would help alleviate drug
register as “outsourcing facilities.”
shortages and reduce government-
imposed costs on prescription drugs.

3. Create floor and ceiling licensure

standards for wholesale distributors
and 3PLs while preserving state
authority for licensure issuance and fee
collection.

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 California
California’s E-Pedigree Law Preempted
On November 27, 2013, President Obama signed Public
Law 113-54. This law contains provisions for a national
track and trace system for prescription medication.
Included within this law are provisions that preempt
California’s e-pedigree requirements. These provisions
are in addition to those in the California Business
and Professions Code that also preempt California’s
provisions should federal legislation in this area be
enacted.

The California Board of Pharmacy made it official late this

afternoon, February 10th, 2014. As required by Section
4034.1 of the California Business and Professions Code
(CB&PC), the Board posted a public notice late yesterday
indicating that sections 4034, 4163, 4163.1, 4163.2,
4163.4, and 4163.5 of the CB&PC became inoperative
due to the enactment of the Federal Drug Quality and
Security Act (DQSA) on November 27, 2013 (see “It’s
Official, President Obama Signs H.R. 3204, DQSA, Into
Law“). These specific sections of the CB&PC comprise
what has been referred to in the industry as “the
California Pedigree Law”.

The public notice was mandated by California law within

90 days of federal preemption.

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Compliance Mandate
• The pedigree shall be created and • A single pedigree shall include
maintained in an interoperable every change of ownership of a
electronic system, ensuring given dangerous drug from its initial
compatibility throughout all stages of manufacture through to its final
distribution. transaction to a pharmacy or other
person for furnishing, administering,
• A pedigree shall include all of the
or dispensing the drug, regardless of
following information:
repackaging or assignment of another
The source of the dangerous National Drug Code (NDC) Directory
drug, including the name, the number.
federal manufacturer’s registration
• A pedigree shall track each dangerous
number or a state license number
drug at the smallest package or
as determined by the board, and
immediate container distributed
principal address of the source.
by the manufacturer, received and
The trade or generic name of the distributed by the wholesaler, and
drug, the quantity of the dangerous received by the pharmacy or another
drug, its dosage form and strength, person furnishing, administering, or
the date of the transaction, the dispensing the dangerous drug.
sales invoice number, the container
• Any return of a dangerous drug to a
size, the number of containers,
wholesaler or manufacturer shall be
the expiration dates, and the lot
documented on the same pedigree
numbers.
as the transaction that resulted in
The business name, address, the receipt of the drug by the party
and the federal manufacturer’s returning it.
registration number or a state
• If a manufacturer, wholesaler, or
license number as determined
pharmacy has reasonable cause to
by the board, of each owner
believe that a dangerous drug in,
of the dangerous drug, and
or having been in, its possession
the dangerous drug shipping
is counterfeit or the subject of
information, including the name
a fraudulent transaction, the
and address of each person
manufacturer, wholesaler, or pharmacy
certifying delivery or receipt of the
shall notify the board within 72 hours
dangerous drug.
of obtaining that knowledge.
A certification under penalty of
perjury from a responsible party of
the source of the dangerous drug
that the information contained in
the pedigree is true and accurate.

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 Argentina
Summary of the Law
• The National Food, Drug and Technology
Administration (ANMAT), through the Regulation
3683, has chosen GS1 Standards to distinctively
identify drugs through the supply chain. Under
the regulation, each unit has to be given a
unique identifier that includes a batch number
and expiration date, allowing the product to be
monitored in the supply chain.

• A distinctive feature of the legislation is the inclusion

of new categories of drugs over a period of time. On
March 28, 2012, ANMAT added new drug classes to
the traceability scheme, including antibiotics, insulin,
clotting factors and a broad range of cardiovascular
drugs and central nervous system treatments
including antidepressants, antipsychotics and drugs
for epilepsy and Parkinson’s disease. Again, in 2013,
the government added more than 200 additional
drugs to the traceability system.

• The government plans to implement the serialization

program on a phased approach with more drugs and
agents being added to the system.

• The Argentine authority tasked with combating

illegal narcotics, SEDRONAR, launched a national
chemical precursors traceability system on 1 January
2013. The system will enable operators to digitally
record precursor transactions nationwide via a
computer network, while allowing regulators real-
time monitoring of precursor movements, and the
gathering and collection of such data for analysis.

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Compliance Mandate
• Pharmaceutical companies must • Each package-unit to be given a
place a support or storing device unique identifier that includes a batch
with capacity to store a univocal code number and expiration date, allowing
supervised and audited by ANMAT the product to be monitored en route
on the package of each of unit of from the manufacturer to distributors,
a medicinal product for sale to the logistics operators, pharmacies,
public. All information must be given in healthcare facilities, and patients.
Spanish.
• Each agent involved in the supply chain
• Suppliers should place a code on must record “logistic movements” of
their packaging complying with GS1 drugs and transmit that information,
Standards. on a real-time basis, to a Database
managed by ANMAT.

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 Brazil
Summary of the law
• The Brazilian Federal Law 11.903 of 2009 and the
subsequent regulations of the National Agency for
Sanitary Surveillance in Brazil (ANVISA) mandate
that a 2D data matrix code be put on all secondary
packaging.

• The 2D data matrix should be with a human

readable text including a Identificador Único de
Medicamentos (IUM), Registration number, Batch and
Validity.

• Each stakeholder in the supply chain is responsible

for capturing, tracking, recording and transmitting of
data to ANVISA.

• The National System of Drug Control proposal

published in April 2013 by ANVISA mandate a 180-
day implementation timeline for manufacturers and
1 year for the rest of the supply chain participants, to
start upon publication of the final regulation.

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Compliance Mandate
• The packaging of medicines must • Distributors are required to control
contain a traceable label. The their distribution chain and attach a
packaging of medicines must be stamp on the medicine packaging,
completely sealed with an unreusable evidencing the authenticity of the
security stamp, not recoverable after product.
any attempt at tampering.
• The secondary packaging should
• Companies holding product incorporate an identifiable feature for
registrations will be responsible for tracking and security. 2D data matrix
generating and placing a unique drug code and associated text to be put on
identifier (IUM) on secondary medicine all secondary packaging.
packs, based on its 13-digit ANVISA
• At identified points along the supply
registration number, plus a serial
chain different stakeholders will be
number, expiration date and
required to supply data to ANVISA.
lot number.

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 South Korea
Summary of the Law
• In Korea, the Ministry of Health and Welfare
notification 2011- 58 amending “Controlling and
indicating barcodes of pharmaceutical products” sets
the law relating to drug traceability.

• Pharmaceutical barcode or RFID tag must be adhered

to primary, secondary and external containers as well
as packaging materials, per items, and per packaging
units.

• Expiration date and lot number information is

mandated in bar codes for traceability of specified
drugs from 2012 and prescription
drugs from 2013, respectively.

• The government aims to have Pharmaceutical Bar

Code or RFID tags on 50% of all drugs in the South
Korean pharmaceutical supply chain by 2015.

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Compliance Mandate
• Manufacturer must adhere or indicate Ethical drugs according to the
barcode or RFID tag to distributed article 2 paragraph 10 of the
pharmaceuticals that are domestically pharmaceutical affairs law
manufactured or imported (excluding (excluding radio pharmaceuticals,
high pressure gas for medical use, orphan drug, cell therapy product),
drug substances manufactured just for or designated drugs according
other manufacturing process, herbal to its ordinance appendix 5,
medicines, product for clinical trials). paragraph 2, B, international
However, pharmaceutical barcode or standard barcode, GS1-128 code
RFID tag can be omitted for empty must be used. However, in case
capsules. that GS1-128code is used to
external containers and packaging
• Pharmaceutical barcode or RFID tag
materials, GTIN-13 can be used to
must be adhered to primary, secondary
primary containers and packaging.
and external containers as well as
packaging materials, per items, and per • In case of indicating RFID tag according
packaging units. to the article 4 paragraph 1, SGTIN-96
or SGTIN-198 should be used (one
• Pharmaceutical barcodes and RFID tags
of the GS1 system). However, in case
must be cared so not to be damaged or
that RFID tag is used, GTIN-13 can be
wiped out in distribution step.
used to one of primary or external
• Types of barcode and component containers or packaging materials.
system:
• In case that Pharmaceutical RFID tag
In case of indicating barcode should be used, manufacturers should
according to the article 4 paragraph notify the minister of health and
1, international standard barcode, welfare the expiry date of shelf life,
GTIN-13 or GS1-128 code (one of lot number that matches each serial
the GS1 system) must be used. number before sales.

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 India
Summary of the Law
• In India, the Directorate General of Foreign Trade
(DGFT) made unique numbers and barcodes
mandatory on tertiary, secondary and primary
packaging for all pharmaceuticals exported from the
country.

• The law also requires incorporation of 2D barcodes

(GS1 data matrix) on medicines at the strip/bottle/
vial level, as well as encoding GTIN and Unique Serial
Numbers by July 1, 2014.

• As per earlier notification of the ministry, the

exporters were to implement barcode on primary
level packaging with effect from July 1, 2013. The
deadline might be extended to 2015 in light of
opposition from the industry.

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Compliance Mandate
• Exporters of pharmaceutical products • Tertiary Level packaging requirement:
will adopt a trace and track system and Incorporation of barcodes
incorporate its features for exported (1 D) encoding unique product
medicines using barcode technology identification code (GTIN), Batch
as per GS 1 global standards as detailed Number, Expiry Date and Unique
below: Serial Number of the Tertiary pack
(shipper/carton).
• Primary Level packaging requirement:
Incorporation of 2D (GS1 Data • Under the track and trace system,
matrix) barcodes on medicines manufacturers would be required
at strip/vial/bottle, etc. encoding to maintain serialized record of
unique product identification code exported pharmaceutical products for
(GTIN) and Unique Serial Number of a minimum period of six months after
the Primary pack. the expiry date of the product.

• Secondary Level packaging

requirement :
Incorporation of barcodes
(1D or 2 D) encoding unique
product identification code (GTIN),
Batch Number, Expiry Date and
Unique Serial Number of the
Secondary pack.

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 China
Summary of the Law
• On April 9, 2008 China’s State Food and Drug
Administration (CFDA) made serialization mandatory
on individual saleable pharmaceutical product units
for 275 therapeutic classes by December 2011.

• From May 1, 2013, China’s Ministry of Health has

released the essential drug list (EDL) of products
requiring serialization. This new list has expanded
the EDL from 307 to 502 products.

• The China National Drug Code (NDC) plus serial

number is required to be printed on primary and
secondary packages up to the pallet with hierarchy
information for the products listed on the EDL.

• China Drug Identification, Authentication and

Tracking System, a division of China Product
Identification, Authentication and Tracking
System (PIATS), provides an online portal for drug
manufacturers and other enterprises that involve
drug supply chain activities to register their products
and obtain serial numbers.

• Chinese law has extended serialization and

compliance reporting to all pharmaceuticals by 2015.

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Compliance Mandate
• The serial numbers need to be acquired documentation and information apply to the provincial food and drug
from the CFDA; the same to be applied technology, and ensuring that administration for its examination and
at the case and unit package level responsible persons are properly approval. Thereafter they should be
and the various commissioning and qualified. confirmed in the system applicable.
inventory movement transactions
• Drug makers importing drugs
across the supply chain need to be
into China must designate a local
reported.
pharmaceutical company, wholesaler,
• The serial number for the subsidiary or other office as their
pharmaceutical drugs would be 20 electronic monitoring agent in the
numeric digits including manufacture country, according to the SFDA.
code, serial number, check digits Overseas drug makers must appoint a
(6 digit codes that has one-to-one Chinese agent to handle all monitoring
mapping with China’s own NDC, 9 activities, including uploading product
digit serial number and 4 checking/ barcodes and facilitating drug recalls.
encryption digits). Additionally, the local agent will be
• 2012 National Essential Drug Lists responsible for reporting vigilance
(NEDL) drug products that are findings to the SFDA. The requirements
domestically packaged (i.e. w/in China) take effect Dec. 31 2013.
need to be serialized and reported • All imported varieties of bid-winning
upon to the China Food and Drug essential drugs should be entered into
Administration (CFDA). the network and coded according to
• 2012 NEDL drug products that are the requirements of documents of
packaged outside of China and SFDA [2010] 194 and 237. For varieties
imported into the country will need to that are sub-packaged in China the sub
be serialized and reported upon to the packaging manufacturers must print/
CFDA. paste the drug electronic supervision
code with a unified logo in the smallest
• If the size of the minimum package is
sales package before March 31, 2011.
too small or the bottles are specially
shaped and under other special • If the imported varieties of bid-winning
circumstances where drug electronic essential drugs that are packaged in
supervision codes with unified logo the original producing areas belong
cannot be printed/pasted the code to circumstances prescribed in the
may be printed on the larger package preceding paragraph, their offices
of the minimum one. If there are any or authorized agents in China shall
such variances the manufacturers apply to the provincial food and drug
should apply to the provincial food and administration for its examination and
drug administration for its examination approval. Thereafter they should be
and approval. Thereafter they should confirmed in the system applicable. If
be confirmed in the system applicable. the imported varieties of bid-winning
essential drugs that are packaged in
• There is an obligation to implement
the original producing areas belong
a quality control system with an
to circumstances prescribed in the
electronic drug monitoring system,
preceding paragraph, their offices
bar codes to ensure pharmaceutical
or authorized agents in China shall
traceability, use of standardized

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 EU
Summary of the Law
• The recently formulated Directive 2011/62/EU on
falsified medicines foresees national enforcement of
drug serialization activities by 2016 across the EU.

• Each member state must transpose the directive

before January 2, 2013 by outlining laws, regulations
and administrative provisions necessary to comply
with the Directive.

• This Directive doesn’t specifically address how

serialization should practically look like and this
is left up to each country. Nevertheless, European
Commission published a Concept paper for public
consultation proposing certain types of serialization
including: linear barcodes, 2D barcodes, and radio-
frequency identification (RFID).

• The barcodes will need to be printed or attached

to every single pack of medicines subject to
prescription and other medicines at risk of being
falsified. The barcodes will be checked into a
database repository system by the manufacturer and
checked out when dispensed by a pharmacy.

• Once all parts of the directive come into force from

2016 onwards, manufacturers failing to comply with
any aspect of the above will no longer be allowed to
market their products in Europe.

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Compliance Mandate
• Manufacturer to choose the • Various ways to carry the serialisation
appropriate technical solution for the number on the outer packaging could
serialisation number and its carrier. be: (a) Linear barcode (b) 2D-Barcode

• In order to allow identification of a pack (c) Radio-frequency identification

of medicinal products, a serialisation (RFID).

number would have to contain, as a • Manufacturers of active substances

minimum, a manufacturer product to comply with good manufacturing
code and the pack number. practice (‘GMP’) for active substances.

• The serialisation number allows for

inclusion of a range of other product
related information such as (a) Batch
number (b) expiry date (c) National
reimbursement number.

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 France
Summary of the Law
• France has also been in the forefront on the
serialization activities. The objective of the program
is to improve the efficiency of batch recalls, to reduce
errors, to combat counterfeiting and reimbursement
fraud and to increase the transparency of the
distribution chain.

• The French CIP13 coding legislation requires all

prescribed pharmaceutical products distributed in
France to include a specified data matrix barcode on
the outer packaging from January 1, 2011.

• The regulations framed by the French Agency of

Sanitary Safety and Health Products (AFSSAPS)
require that a 2D matrix barcode containing the
new CIP 13 code, batch number, and expiry date be
printed on each item of sale.

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Compliance Mandate
• All prescribed pharmaceutical products • Code is batch-specific not pack-specific,
distributed in France to include a and only changes when the batch
specified data matrix barcode on the number or expiry date changes.
outer packaging.
• Manufacturers, distributors, pharmacies
• The requirement is to incorporate a and hospitals will be required to trace
fixed CIP13 number (effectively an SKU products by an electronic receipt
number or pseudo-GTIN) plus batch notice.
number and expiration date, into an
ECC200 datamatrix code.

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 Turkey
Summary of the Law
• Turkey’s objective in launching the serialization
program was to reduce instances of pharmaceutical
reimbursement fraud. As of July 1, 2010, all
pharmacists in Turkey’s serialization scheme (ITS)
were officially unable to gain reimbursement for
medicines not carrying the 2D data matrix barcode.

• The Turkish Ministry of Health (MOH) requires

serializing and tracking using 2D data matrix
technology for all unit-level items that are
reimbursed by MOH, including promotional samples,
hospital packaged products, prescription drugs, and
non-prescription drugs.

• Turkey’s requirements have evolved in recent years

to require that more data be recorded at more points
along the supply chain.

• Another bright feature of the serialization framework

in Turkey is the use of a centralized government
database for managing all pharmaceutical serial
numbers. All parties in the supply chain must report
their receipt and sell data to the database or risk their
product being restricted from distribution.

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Compliance Mandate
• All the transactions of the drug units • Composition of Barcodes:
from their production to consumption The company owning the product shall
are recorded by the system through be responsible for the smooth reading
notifications. After the transactions, by the automatic data collectors
stakeholders to transfer the final status (barcode readers) for the composition
and ownership information of the drug of the barcodes to be placed on
units to İTS. Medical Products for Human Use. When
designating the quality principles of
• The following identifiers will be used in
the barcodes and data matrices to be
the identification of Medicinal Products
composed, the following standards
for Human Use: GTIN-Global Trade Item
shall be taken as basis in relation with
Number, Serial Number, Expiration
barcode verification:
Date, Batch/Lot Number and Group
seperator (FNC1). For Linear Barcodes (EAN-13,
GS1-128): TS EN ISO/IEC 15416
• The GTIN (Barcode Number) in EAN-13
Information Technology –
Barcode Symbology might be printed
Automatic identification and data
on the product package as the primary
capture techniques – Barcode
identifier.
printing quality trial property;
• Data Matrix: All identifying information Linear symbols.
indicated in Article 4 of the Guidance
For Dimensional Barcodes (Data
on implementation of Identification
Matrices): TS EN ISO 15415
and barcoding of medicinal products
Information technology –
or human use will be included as
Automatic identification and data
secondary identifier in Data Matrix
capture techniques – Barcode
symbology on the package of the
printing quality trial property
Medicinal Product for Human Use.
specification – Two-dimensional
• The data matrix, as a Datamatrix symbols.
barcode in ECC200 standards, may
be printed in either the square or the
rectangle form, as indicated in the
mentioned standard. This printing
form shall be determined by then
manufacturer/importer.

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 References:
US Federal Argentina • Article on National System of Control
• Prescription Drug Marketing Act -- • Argentina Launches Drug Precursors of Medicines (Law 11.903) by Domino
Pedigree Requirements under 21 CFR Tracking System-January 23, 2013 Printing Sciences plc
Part 203 • Brazil opens public comment on
• Several Market Access Barriers Impede
• Safeguarding America’s Multinational Companies From Easily traceability proposals-Apr 3 2013
Pharmaceuticals Act of 2013 (H.R. 1919, Accessing Argentina’s
113th Cong) South Korea
• Pharmaceutical Market But Attractive
• Drug Supply Chain Security Act (S.957, Opportunities Exist-May 30, 2013 • Drug Traceability-By Procurement
113th Cong.) Intelligence Unit
• Regulation 3683 in Non-English
• Proposed Rule: FDA Proposes to language • GS1 Healthcare Reference Book
Remove Certain Requirements Related 2011/2012
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to PDMA • Guidelines for Use and Managing of the
language
• FDA Guidance for Industry-Standards Pharmaceutical Bar code
• Argentina Medicines Traceability
for Securing the Drug Supply Chain - • Ministry of Health and Welfare
system
Standardized Numerical Identification notification 2011- 58
for Prescription Drug Packages • Order No.1831 of 2012
• Healthcare Activities in Korea
• 21 USCS § 353 (e)(1)(a) • Argentina extends traceability
programme for medicines-By Phil • Impact of a Two-Dimensional Barcode
• 21 CFR 820.60 (2013) for Vaccine Production, Clinical
Taylor, February 22, 2013
• 21 CFR 203.50 (a) Documentation, and Public Health
• Notice 0247 dated January 15, 2013
• 21 CFR 203.50 (b) Reporting and Tracking-Final Report-
regarding additions of medicines to the
July 2012
• 21 CFR 201.25 system
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Requirements 2013 • Track & trace to help check spurious
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- http://energycommerce.house.gov/ sciences-Argentina- By Emilio N June 6, 2013
fact-sheet/hr-3204-drug-quality-and- Vogelius, Hugo J Eppens Millán, • India’s Insights into Serialization, April
security-act Florencia Rosati and Ana Andrés 17,2012
Estudio Beccar Varela, Practical Law
California • DGFT Public Notice No.21 (RE-
Company, 2012
2011)/2009-2014 dated January 10,
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California ePedigree Law Quarter 4 – 2011
• DGFT Public Notice No. 54 (RE-
• California Business and Professions • IDRAC- Argentina, ANMAT Information 2012)/2009-2014 dated April 5, 2013
Code, Chapter 9 Note Disposition
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• California Business and Professions • Medicine use revisited: Three per DGFT guidelines
Code § 4034 secondary levers
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• California Business and Professions • Implementing drugs traceability in 2012)/2009-2014 dated July 11, 2012
Code § 4126.5 Argentina-By Maximiliano Derecho
• California Business and Professions China
Code § 4163.1 Brazil
• China SFDA Mandatory Serialization
• California Business and Professions • GS1 Healthcare Reference Book Update-06/01/2009
Code § 4169 2012/2013
• Improving quality,optimize supply
• California Business and Professions • Brazil Proposes Pharmaceutical chain, implementing traceability-
Code § 4085 Serialization and Traceability System Global challenge for pharmaceutical
• California Business and Professions • Serialization – A Worldwide Challenge- industry-By Gilberto Rossi Giuseppe
Code § 4163.5 (b) By Dana Buker and David Loy, Sep/Oct Ruggirello, Sep/Oct 2010
2012 • PIATS Website
• The California Pedigree Law Is Now
Officially Inoperative - http://www. • National System of Control of • China Serialization Deadlines for 2012
pharmacy.ca.gov/about/e_pedigree_ Medicines (Law 11.903) National Essential Drug List-May 23,
law_preempted.shtml • Life Sciences 2012 2013

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• The Long Road To Serialization-By Gail • Responses to the public consultation • 03.07.2012 | Public Information – The
Dutton, March 28 2012 on the concept paper Pharmaceutical Track and Trace System
• China Finalizes Revised Drug • Directive 2001/83/EC on the Operates Trouble-Free
Distribution Rules-By Louise Zornoza, Community code relating to medicinal • ITS System-Scope
Feb 20, 2013 products for human use • Guidance on implementation of
• China Essential Drug List Update-By • European Commission Information on Identification and Barcoding of
Ken Fallu, May 22, 2013 Falsified Medicines medicial products for human use, 2008
• China SFDA Mandatory Serialization • Overview of the transposition status of • Regulation To Amend The Regulation
Update-Global Track and Trace, all Member States On Packaging And Labeling Of
06/01/2009 • Implementation measures by the Medicinal Products For Human Use,
• China SFDA Mandatory Serialization European Commission May 2009
Update-Global Track and Trace, • List of third world countries ensuring • Regulation Amending The Regulation
06/01/2009 level of protection of public health On The Packaging And Labeling Of
• Good Supply Practice for equivalent to that in EU Medicinal Products For Human Use,
Pharmaceutical Products (No.90 Decree December 6, 2008
• FAQs-Importation of active substances
of the Ministry of Health of the People’s for medicinal products for human use • Regulation on Packaging and Labeling
Republic of China) of Medicinal Products for Human Use,
• Implementing Decision
• Summary of Good Supply Practice for December 8, 2005
• New rules on importing active
Pharmaceutical Products • Notification-The Notifying of Products
pharmaceutical ingredients
• China: Imported Drugs Must Have Local to İTS which have Newly Obtained a
• Concept paper related to Unique License-Notification Feb 27, 2012
eMonitoring Representative-China:
Identifier for Medicinal Products
Imported Drugs Must Have Local • Notification-About the PTS
eMonitoring Representative, Notifications of Manufacturer
France
Feb 26 2013 Companies and Pharmaceutical
• French CIP13 coding legislation-By Wholesalers-Feb 28, 2012
• China Supplementary Notice on
Domino
Further Strengthening Electronic • Notification- To the Attention of all the
Supervision of Essential Drugs-Global • Coding Packs for France (CIP13): Is Companies which have the Authority
Track and Trace, 12/28/10 Your Equipment Also Suitable for to Export Pharmaceuticals and/or
Serialization?-By Mark Davison Companies which make Distributions
• Serialization for China e-coding: a CMO
perspective, By Arianna Albertella & • Datamatrix the way forward for French for Pharmaceutical Exportation
Actavis Italy Spa, Apr 16 2013 pharmaceuticals industry-By Avery Purposes-December 30, 2011
Dennison • 05.01.2012 | About the Sharing of Error
• Serialization for China e-coding: a CMO
perspective, By Arianna Albertella & • On the right track- By Manufacturing Codes
Actavis Italy Spa, Apr 16 2013 Chemist, Pharma, Aug 5, 2011 • Notification-About Phase 2 Processes of
• China SFDA Mandatory Serialization • France is first to set the code-By Pharmaceutical Wholesalers-December
Update, 06/01/09 Manufacturing Chemist, April 21, 2011 23, 2011

• Webinar: China Track and Trace - • France CIP 13 Coding Update-06/01/20 • ITS News and Notifications
Serialization and Reporting Compliance • Track and Trace Working Principles
Turkey
• Good Supply Practice for • ITS News-Sep 17, 2012
Pharmaceutical Products (No.90 Decree • Improving quality, optimize
• ITS Announcement-December 22, 2011
of the Ministry of Health of the People’s supply chain, implementing
Republic of China) traceability:a global challenge for the
The various updates on the tracking
pharmaceutical industry, By Gilberto
requirements are being reflected in the ITS
EU Rossi and Giuseppe Ruggirello, Sep/Oct
website under the following links:
2010
• Directive 2011/62/EU on falsified • ITS Announcements
medicines • ITS Announcement July 03, 2012
• ITS News
• Concept paper submitted for public • News on Turkey’s Tracking & Tracing • ITS on Press
consultation System-GMP News, June 30, 2010
• ITS Events

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