Pharma
| REGULATORY AGENCY | Brazil National Agency of Sanitary Surveillance (ANVISA) |
| REGULATION NAME | Federal Law no. 11,903/2009 & 13,410/2016 |
| COMPLIANCE DATES | 28th April, 2022 : All the drugs must be serialized and their supply chain movements must be reported to ANVISA (According to draft) |
| APPLIES TO | Domestic manufacturers of prescription pharmaceutical products Importers of prescription pharmaceutical products |
| BARCODE SYMBOLOGY | Datamatrix (ISO / IEC 16022 Standard) |
| BARCODE CONTENTS | The Unique Medication Identifier (IUM); which consists
|
| SERIAL NUMBER RANDOMIZATION | No |
| SERIAL NUMBER REUSE |
Not Specified |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
GS1 Standards |
| FREE SAMPLES MUST BE MARKED? |
Not Specified |
| BARCODE SYMBOLOGY |
GS1 standard |
| BARCODE CONTENTS | Perhaps, similar to Unit-level packaging |
| LOGISTICS UNITS MUST BE SERIALIZED? | Yes; Aggregation can be done with SSCC, SGTIN or CNPJ based aggregator |  | |
| PARENT-CHILD MAPPING AGGREGATION CAPTURE? | Yes |
| SEND UNIT DATA TO GOVERNMENT REPOSITORY? | Yes |
| SEND UNIT DATA TO THIRD-PARTY REPOSITORY? | As applicable |
| SEND UNIT DATA TO TRADING PARTNER? | As applicable |
| SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY? | Yes |
| SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY? | As applicable |
| SEND AGGREGATION DATA TO TRADING PARTNER? | As applicable |
| WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION? | ANVISA |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? | Yes |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT? | Yes |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT? | No |
| MANUFACTURER ACTIVITY REPORTED? | Yes |
| DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED? | Yes |
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in
