Pharma
| REGULATORY AGENCY |
National Agency for Food and Drug Administration and Control (NAFDAC) |
| REGULATION NAME |
National Pharmaceutical Traceability Strategy |
| COMPLIANCE DATES |
While the Agency has been designated to enforce these regulations, the timeline for implementation has not yet been specified. |
| APPLIES TO |
• These Regulations provides regulatory framework for the traceability of drugs and related products manufactured, imported, distributed, sold or used in Nigeria. • These Regulations shall apply to the traceability of drugs and related products manufactured, imported, exported, advertised, sold, distributed or used in Nigeria |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| BARCODE SYMBOLOGY |
GS1 Data Matrix (Proposed) |
| BARCODE CONTENTS |
|
| SERIAL NUMBER RANDOMIZATION | Not Specified |
| SERIAL NUMBER REUSE |
Not Specified |
| HUMAN READABLE EXPIRY DATE FORMAT |
Not Specified |
| BARCODE DATA ENCODING |
GS1 Standards |
| PRODUCT CODE NOTES |
NA |
| FREE SAMPLES MUST BE MARKED? |
No |
(A shipper containing one or more secondary packs)
| BARCODE SYMBOLOGY | SSCC Code (Proposed) | |
| BARCODE CONTENTS |
Not Specified |
|
|
PARENT-CHILD MAPPING AGGREGATION CAPTURE? |
No |
| SEND UNIT DATA TO GOVERNMENT REPOSITORY? | Proposed |
| SEND UNIT DATA TO THIRD-PARTY REPOSITORY? |
No Specified |
| SEND UNIT DATA TO TRADING PARTNER? |
No Specified |
| SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY? | No Specified |
| SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY? |
No Specified |
| SEND AGGREGATION DATA TO TRADING PARTNER? |
No Specified |
| WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION? |
No Specified |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? |
Proposed (Import & Exports) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT? |
No Specified |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT? | No Specified |
| MANUFACTURER ACTIVITY REPORTED? | Yes (Proposed) |
| DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED? |
No Specified |
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.
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
