HOME
> INDUSTRY
SOLUTIONS > EUROPEAN PRESCRIPTION DRUG
TRACKING
The
recent focus has been on regulations relating to
the 2011 European Falsified Medicines Directive
(FMD), referred to as DIRECTIVE 2011/62/EU,
which amends EU Directive 2001/83/EC relating to
the prevention of entry of falsified medicinal
products into the legal supply chain in Europe.
The specific details for the
implementation are being defined now and the law
is scheduled to become effective in 2017.
The requirements for encoding packages and
for tracking product information have been
widely discussed and are integrated into
business strategy and requirements for our
clients. Several organizations, including EDQM
and European Federation of Pharmaceutical
Industries and Associations (EFPIA) are
preparing guidance to comply with the 2011
European Falsified Medicines Directive (FMD).
There are several very
specific requirements for manufacturers and
wholesalers that will be defined based on your
company procedures and business systems.
Projects have
delivered (1) strategy, (2) project roadmap and
plans, (3) User Requirement Specification (URS)
for (a) enterprise serialization, (b) packaging
systems, (c) warehouse/shipping (referred to as
EDGE), and (d) regulatory reporting such as
e-pedigree, (4) contract manufacturer and
logistics provider requirements and governance,
(5) compliance with global regulatory
requirements, (6) functional and design
specifications, (8) business system and
packaging designs and architectures, (9) pilot
planning and scenarios, (10) GAMP based
validation, and (11) vendor selection.
Projects have included solutions involving
serialization, track and trace, electronic
pedigree (e-Pedigree), country traceability
reporting (i.e., Turkish Ministry of Health,
China, etc.), radio frequency identification
(RFID), barcoding and scanning, GS1 electronic
product code information services (EPCIS),
supply chain, warehousing and Electronic Data
Interchange (EDI). Pharma Logic Solutions is a
longstanding Solution Provider for GS1 US
Healthcare.
Strategy, business and
user requirements, designs and implementations
have included solutions from SAP (ECC, SCM, Aii,
OER, Aie), JD Edwards, Oracle (OPSM, OPM),
Manhattan Associates, MAPICS, Acsis
(ProducTrak), Axway, rfXcel, Frequentz, Systech, Optel Vision (TrackSafe, Line
Master, PharmaProof), Cognex, Mettler Toledo,
Seidenader (Körber Medipak), Antares Vision
(Xyntek), Laetus, ROC-IT Solutions, TAKE
Solutions, Uhlmann, Nosco, Werum PAS-X,
Tracelink, Videojet and others.
Contact us to
discuss your needs and contrast the
Pharma Logic Solutions solutions against previous providers to
see why our approach is the
ideal solution. |
