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WEBINAR AND QUARTERLY REGULATORY UPDATE
14 MARCH, 2017
A Closer Look At Brazil’s New Serialization Regulation
This webinar is intended to be
interactive
Information contained in this webinar is current as of
March 2017
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BEFORE WE GET STARTED…
WEBINAR SERIES
DIRK RODGERSREGULATORY STRATEGIST FOR SYSTECH INTERNATIONAL
Dirk is widely acknowledged to be one of the global experts on the current and emerging set of pharmaceutical regulations on serialization and traceability. He is the founder of RxTrace.com where he writes regularly in exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards, and regulatory compliance.
PRESENTER
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History of Brazil’s Pharma Serialization Efforts
Brazil Law Number 13,410-2016
The Latest Draft Regulations From ANVISA
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Systech Quarterly Regulatory Update
History of Brazil’s Pharma
Serialization Efforts
BRAZIL RDC-54 (SUSPENDED)
Implementation timelines• Phase 1 deadline: December 10, 2015 (serialization and tracing data for 3 batches of product)• Phase 2 deadline: December 10, 2016 (serialization and tracing for all pharmaceuticals)
Key provisions• Serialization: Unit-level serialization, using a 2D Data Matrix barcode, which includes a 13-digit ANVISA drug registration number,
unique randomized serial number, expiration date and lot number. These combine to form the ANVISA Unique Identifier of Medicines (IUM). The serial number cannot be repeated between the units of any product manufactured by the registration holder and, in the case of importers, between products from the same manufacturer.
• Aggregation: Unit-to-case hierarchy required to support supply chain tracing events. • Supply Chain Tracing: All movements of units of sale and distribution of medicines must be recorded and stored by the participants
of the pharmaceutical supply chain, including reverse logistics. This includes tracing of transportation activities.• Manufacturer: Shall maintain the database with record of all movements of the IUM in the pharmaceutical supply chain including: IUM,
identification number (CNPJ) of drug recipients, identification number (CNPJ) of transport companies, date/type of drug transaction, transport packaging (case) identifier.
• Distributor: Provide serialized product transaction data back to the Manufacturer. Maintain a real-time database of all transactions managed containing: IUM, identification number (CNPJ) of companies selling to or receiving drugs from the distributor, identification number (CNPJ) of transport companies, date/type of drug transaction, transport packaging (case) identifier.
• Dispenser / Pharmacy: Provide serialized product transaction data back to the Manufacturer and Distributor. Maintain a real-time database of all transactions managed containing: IUM, identification number (CNPJ) of companies selling to or receiving drugs from the dispenser, identification number (CNPJ) of transport companies, date/type of drug transaction, transport packaging (case) identifier.
• Data Archival: One (1) year after the expiration date of the drug product.
BRAZIL RDC-54 (SUSPENDED) SUPPLY CHAIN VIEW
CMO/CPO
ANVISA
Manufacturer Wholesaler Dispenser Pharmacist
Product Serialization Repository
Product Serialization Repository
Product Serialization Repository
POLL
Brazil Law Number 13,410-2016
BRAZIL LAW NUMBER 13,410-2016Implementation Deadlines• ANVISA Regulations Published: April 29, 2017 (may be extended if necessary)• 3-Lot Pilot by Selected Participants: April 29, 2018• ANVISA Pilot Report & Final Regs: December 29, 2018• All Products Serialized and Traced: December 29, 2021
Key provisions• Serialization: Required• Aggregation: Not specified in the law• Supply Chain Tracing: Central repository, product movement data provided by each owner in the supply chain• Data Archival: Not specified in the law, may end up in the regulations
The Latest Draft Regulations
From ANVISA
DRAFT ANVISA REGULATIONSKey provisions• Serialization: Unit-level serialization, using a 2D Data Matrix barcode, which includes a GS1 GTIN,
a 13-digit ANVISA drug registration number, unique serial number, expiration date and lot number. These combine to form the ANVISA Unique Identifier of Medicines (IUM).
• Aggregation: Not specified in the draft regulation• Supply Chain Tracing: Central, government-run repository. All members of the supply chain must
upload event data within 3 to 7 days.• Data Archival: All members of the supply chain must hold a copy of their event data for at least
one year after the drug’s expiration date
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1011
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NEW BRAZIL SUPPLY CHAIN VIEW
CMO/CPOANVISA Manufacturer Wholesaler Dispenser Pharmacist
Central Product
Movement Repository
101010110010Product
Movement Repository
101010110010
Product Movement Repository
101010110010
Product Serialization & Movement Repository
QUARTERLY REGULATORY UPDATE
MARCH 2017
New official documents have surfaced:- October 2016: Proposed pharma serialization pilot- January 2017: Decree authorizing the pilot
Pilot:- February 1, 2017 to December 31, 2017- Voluntary participation- Final report due, February 1, 2018
The October proposal included a mandatory, 100% serialization requirement that would start on December 31, 2018 but this was not part of the January decree. It is unclear if that requirement and deadline are in effect.
RUSSIA
New post on CFDA website in January appears to mandate the use of China’s existing 14-digit National Drug Code as a “kind-of GTIN substitute”:
• WARNING: Interpreting the meaning of documents
released by the CFDA is notoriously hard.
• “Bit Code” is only unique to the drug, not to the package
• Must be encoded in a barcode on each package
CHINA
AliHealth announced that they will no longer “update” or offer support for the website that provides the old unique drug package identifiers.
EGYPT
UNITEDSTATES
E.U.
https://www.emvo-medicines.eu/
POLL
© 2017 Systech International. 21
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SYSTECH REGULATORY UPDATE PDFs
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