Beruflich Dokumente
Kultur Dokumente
Agenda
Brazil High-Level Compliance Summary and Network
Serialization, Tracking/Data Exchange and Reporting Requirements
Funding Model
Governance Model
Data and System Security
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission
Deadlines
Dec. 10, 2015
Serialization (unit-level)
Serialization (unit-level)
Government Reporting
Government Reporting
All pharmaceuticals
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission
ANVISA System
(industry developed)
XML
Pharmaceutical Company
3PL
Carrier
(registration holder)
Wholesale
Distributor
Pharmacies /
Hospitals / Dispensers
Packaging Site
4
CMO / CPO
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission
Serialization Requirements
Drug registration holders (manufacturer, importer) are responsible for serializing drug products
- Unit level
- Transport container (case) level
A Brazilian IUM is applied to each unit of product in a 2D datamatrix (must be in this order)
ANVISA Registry Number
13 digits
SN
13 digits
Expiry
MM/YY format
Lot
* Note: a GTIN may be added but must not come within the four required IUM data elements
Aggregation is required
- Transport packaging container must contain an identifier linking the container to the unit IUMs
5
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission
Distributor
Product IUM
Transport Package identifier
Brazil CNPJ identifier (sender)
Brazil CNPJ identifier (receiver)
Brazil CNPJ identifier (carrier-if applicable)
Date of transaction
Type of transaction (sale, transfer, etc.)
Receiving
Purchase
Transfer
Donation
Return
Payment
Free Sample
Delivery
Sale
Transfer
Donation
Return
Payment
Free Sample
Production
IUM
Import
Carrier
Packing
Disposition
Dispensation
Shortage
Deviation
Loss/Damage
Destruction
Pharmacy Dispenser
Product IUM
Transport Package identifier
Brazil CNPJ identifier (sender)
Brazil CNPJ identifier (receiver)
Brazil CNPJ identifier (carrier-if applicable)
Date of transaction
Type of transaction (sale, transfer, etc.)
Error Correction
Invalid event
Replacement event
Reporting
Transmission
Receipt
Expected that supply chain members will use XML and other means to exchange event data
All product movement data must be stored for 1 year post product expiration date
6
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission
Reporting Requirements
Product and supply chain event reporting by registration holders to ANVISA
- Web service XML-based communication
Defined in XSD schema files documented on the ANVISA website
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission
Funding Model
ANVISA central repository
- ANVISA has started to develop the specifications of a central repository system
- ANVISA will ask industry to develop and manage such a system on their behalf
- Funding requirements for this system (from registration holders or from all stakeholders) has not yet been
publicly defined
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission
Governance Model
ANVISA has developed a formal group steering committee to advise on the structure, operational processes
and technical design
- 25 core members (ANVISA, Brazil Ministries, National Councils, Industry Associations)
- Subcommittees focus on specific aspects of RDC 54 readiness
Public Sector
Etc.
ANVISA is generally leaving it to industry to develop and manage the process of implementation of
interoperable data exchange systems
- Industry stakeholders may have their own private SNCM system or use a system shared with other stakeholders
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission
ANVISA has not yet extensively documented explicit requirements for security
Events and data captured by the SNCM system for RDC 54 must be protected and remain unchanged
- Any update/removal of historical data throughout record retention period will be considered a regulatory infraction
NOTE: A Replacement Event or Declaration of Invalidity should be used to correct regulatory records
- After the record retention period expires for a specific event, records related to that event may be removed
- Data managed by the SNCM system beyond that required for regulatory purposes may be modified
Authentication, Encryption
- Data access controls for ANVISA to access registration holders SNCM systems
Additional security issues expected to be left to industry to define (but may be part of certification)
- Data security within SNCM systems
- Transaction security across supply chain stakeholder data exchanges
10
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission
Questions
11
2014 TraceLink Inc. All Rights Reserved Confidential Not for Redistribution Without Express Permission