Pharmaceutical Commerce - June 2018 - 16

F E AT U R E

Counterfeiting protection for medicines:
BY NADINE LAMPKA AND ARNE REHM, SCHREINER MEDIPHARM

EU

requirements for protecting medicines against counterfeiting will
become mandatory in February 2019. Consequently, pharmaceutical
manufacturers are preparing to meet these demands with 2D
identification codes and sealing of their sales packs. However, they should be aware
that this measure alone will not guarantee a product's integrity or authenticity. Only
the combination with additional counterfeit-proof authenticity features can offer a
comprehensive approach against fraud, misuse and tampering. Customized multilevel security concepts, including analog as well as digital features like NFC (Near Field
Communication) ensure that all stakeholders, if informed expert or end user, can be
involved in the authentication process.
Enhancing supply chain security

By means of EU Directive 2011/62/EC, the so-called
Falsified Medicine Directive (FMD), legislators and
pharmaceutical manufacturers intend to safeguard the
supply chain in Europe. Effective February 9, 2019, every
manufacturer must provide most of the prescription medicine
packs (exceptions on white list) and a selection of high risk
non-prescription packs (on black list) with an individual
serial number in the form of a 2D code (DataMatrix) and a
tamper protection feature. Thus, patients shall be protected
against falsified medicines. As the requirements set out in
the valid version have been known since October 2, 2015,
the roadmap for those who need to take action is clear. The
level of the counterfeiting risk determines whether or not a
medicine has to be provided with these security features.
The Drug Supply Chain Security Act (DSCSA) mandates
the development and implementation of standards for
drug product tracing, to be phased in by 2023. A tamperverification feature is not part of the DSCSA. In terms
of physical packaging, the FMD and the DSCSA do differ
in many details besides this. Since the demanded safety
features were released, it seems that tamper-verification
measures in general gained attention with respect to the

16 \ Visit our website at www.PharmaceuticalCommerce.com \ 06.2018

value they provide to secure a product´s integrity and the
manufacturer's brand.

Serialization plus authenticity

Serialization by means of 2D codes, as required by the EU
Directive, opens up additional opportunities to the industry.
It controls internal logistics processes more efficiently
and offers clear identification of every individual medicine
pack. However, further actions are necessary to convert
an easy-to-copy serialization code into an authenticity
feature for effective verification. Deep industry knowledge
combined with specialized know-how in materials and
printing technologies are prerequisites for developing
tamper protection and anti-counterfeiting solutions for the
pharmaceutical industry.
Effective security solutions for diverse threat scenarios
can be divided into three categories:
1. A label may clearly indicate first-opening and
tampering.
2. Integrated technologies of various security and
detection levels provide effective protection against
counterfeiting.
3. Track & trace system solutions serve to identify and


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Table of Contents for the Digital Edition of Pharmaceutical Commerce - June 2018

Table of Contents
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Pharmaceutical Commerce - June 2018 - Table of Contents
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Pharmaceutical Commerce - June 2018 - Cover3
Pharmaceutical Commerce - June 2018 - Cover4
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