Pharma
| REGULATORY AGENCY | Agencia Nacional de Regulacion, Control y Vigilancia Sanitaria (ARCSA) |
| REGULATION NAME | Guidelines for traceability Control for strategic Medicines and Goods for health in Ecuador |
| COMPLIANCE DATES | Implementation of traceability deadline for each phases: |
| APPLIES TO | All Medicines produced in Ecuador or imported and to be purchased by the Ecuadorian State and prescribed in public health institutions to be dispensed by public hospitals |
(Packaging which is in direct physical contact with the active ingredient)
| BARCODE SYMBOLOGY | 2D or linear barcode |
| BARCODE CONTENTS |
|
| SERIAL NUMBER RANDOMIZATION | No Specified |
| SERIAL NUMBER REUSE |
No Specified |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
GS1 DataMatrix |
| PRODUCT CODE NOTES | Requirements as applicable: Packaging levels: as of secondary packaging level GS1 standards required Data carriers: 2D or linear barcode Data elements: GTIN, lot, serial number and expiration date SSCC on logistics units |
| FREE SAMPLES MUST BE MARKED? |
No |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| BARCODE SYMBOLOGY | 2D or linear barcode |
| BARCODE CONTENTS |
|
| SERIAL NUMBER RANDOMIZATION | NA |
| SERIAL NUMBER REUSE |
No |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
GS1 DataMatrix |
| PRODUCT CODE NOTES |
Requirements as applicable: |
| FREE SAMPLES MUST BE MARKED? |
No |
(A shipper containing one or more secondary packs)
| BARCODE SYMBOLOGY | SSCC |  | |
| BARCODE CONTENTS | GS1-128 (SSCC) | ||
PARENT-CHILD MAPPING AGGREGATION CAPTURE? | Yes |
| SEND UNIT DATA TO GOVERNMENT REPOSITORY? | ARCSA database |
| 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? | Agencia Nacional de Regulacion, Control y Vigilancia Sanitaria (ARCSA) |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? | Yes (Import & Exports) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT? | Yes |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT? | Yes |
| 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