The Pharma Industry’s
Benefits of MES systems as level 3 track-and-trace solutions.
By Jürgen Laskowski, Director, Track & Trace, Werum IT Solutions, & Zaim Imeraj, Project Manager,
Werum IT Solutions
Counterfeit drugs have become an increasing lobal threat over the last few decades.
More and more regulatory
authorities, including those
of Argentina, Brazil, India,
South Korea, Saudi Arabia,
and Turkey, have adopted
or will adopt requirements
for the use of globally
unique drug identifiers and
serialization in order to
protect the supply chain.
These new rules, of course,
are in addition to existing
and pending track-and-trace
regulations in the U.S. and
The U.S. Drug Quality and Security Act
The Drug Quality and Security Act (DQSA) was
signed into law in 2013. It outlines critical steps
to build an electronic, interoperable system for
identification and traceability of prescription
drugs as they are distributed in the U.S. The new
law supersedes any individual state guidelines.
The requirements are phased in over a period of
10 years by providing a migratory path from lot
traceability to serialization to item-level traceability.
The next big step will be the introduction of
mandatory medicinal product serialization in 2017.
EU Falsified Medicines Directive
One of the key objectives of the European
Directive on preventing falsified medicinal products
from entering into the supply chain is to ensure
product integrity and authentication of medicines,
i.e. safety features and product serialization. To
effectively accomplish this means a harmonized
unique identifier across Europe. Adopted in 2016,
the Delegated Acts on safety features (Regulation
2016/161) lay out the technical parameter of the
greater EU Falsified Medicines Directive (FMD),
setting up the first “end-to-end verification system”
for drugs across the world. The requirements must
be implemented by EU member states by February
2019 (2025 for Belgium, Italy, and Greece).
However, implementation at national level can
be completed before the end of these transition