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SOLUTIONS > BRAZILIAN ANVISA PRESCRIPTION DRUG
TRACKING
The recent
focus has been on regulations relating to the
Brazilian Brazilian Resolution No. 54 by the
Joint Board of the National Health Surveillance
Agency (ANVISA — Agencia Nacional de Vigilancia
Sanitariar). The new law established rules and
provisions for implementation of a national
system of drug product identification and
tracking throughout the pharmaceutical supply
chain. Provisions adopted following a pubic
comment period starting on April 2, 2013. The
law was Published/Adopted on December 10, 2013.
Brazilian Resolution No. 54 and AVISA
established that by December 10, 2015 (2 years
from effective date) manufacturers must provide
to ANVISA a set of complete tracking data for 3
lots of drug product including all transactions
down to the point of dispensation. Likewise, by
December 10, 2017 (3 years from effective date),
all drug products must be serialized, tracked
and reported and all supply chain participants
must have required identification and tracking
systems in place.
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. |
