Pharma
| REGULATORY AGENCY | The Botswana Medicines Regulatory Authority (BoMRA) |
| REGULATION NAME | Medicines traceability vision and strategy |
| COMPLIANCE DATES | The government will set up requisite regulatory instruments in 2022-2023 timeframe at which point it will become clear the traceability model to be adopted and other relevant information. |
| APPLIES TO | Drug manufacturers who have manufacturing and/or packaging facilities within Botswana, and who export drugs to any other countries. |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| BARCODE SYMBOLOGY | Linear, or 2D Datamatrix following GS1 standards |
| BARCODE CONTENTS |
|
| SERIAL NUMBER RANDOMIZATION | No |
| SERIAL NUMBER REUSE |
Not Specified |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
GS1 Standards |
| PRODUCT CODE NOTES |
In the case of “mono cartons”, a manufacturer or exporter shall affix the bar code on mono cartons containing one primary pack on an optional basis until further notice |
| FREE SAMPLES MUST BE MARKED? |
Not Specified |
(A shipper containing one or more secondary packs)
| BARCODE SYMBOLOGY | GSl -128linear | | |
| BARCODE CONTENTS | Product code (use of the GS1 GTIN is now optional), Lot Number,Expiration Date, GS1 SSCC (SSCC may appear in a separate barcode) | ||
|
PARENT-CHILD MAPPING AGGREGATION CAPTURE? |
Not Specified |
| SEND UNIT DATA TO GOVERNMENT REPOSITORY? | No |
| SEND UNIT DATA TO THIRD-PARTY REPOSITORY? |
As applicable |
| SEND UNIT DATA TO TRADING PARTNER? |
As applicable |
| SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY? | No |
| SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY? |
As applicable |
| SEND AGGREGATION DATA TO TRADING PARTNER? |
As applicable |
| WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION? | Proposed |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? | Yes (Exports) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT? | No (Future) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT? | No |
| MANUFACTURER ACTIVITY REPORTED? | No |
| DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED? |
No |
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