Pharma
| REGULATORY AGENCY | The Ministry of Health and Prevention, UAE (MOHAP) |
| REGULATION NAME | Tatmeen Project, a platform for tracking and tracing serialized pharmaceutical products to improve and secure the country’s healthcare supply chains. |
| COMPLIANCE DATES | The deadline for uploading and transferring data to Tatmeen portal is 13th December 2022. |
| APPLIES TO | All conventional medicines sold, distributed, or stored in the UAE |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| BARCODE SYMBOLOGY |
2D Datamatrix following GS1 standards |
| BARCODE CONTENTS |
|
| BARCODE SEQUENCE | Encoding Options (any of below)
|
| SERIAL NUMBER RANDOMIZATION | Yes |
| SERIAL NUMBER REUSE |
Not Specified |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
GS1 Standards |
| PRODUCT CODE NOTES |
Logistic Units must be aggregated and identified with an SSCC (Serial Shipping Container Code). Aggregation is to be done by the manufacturer on all applicable packaging levels to ensure ease of downstream reporting. Distributors, wholesalers and health facilities that unpack and re-pack products to deliver to points of dispensing are required to aggregate the Logistic Units using their own SSCC codes. If, in addition to being a Logistic Unit, the item is regarded as a Trade Item by the brand owner, it may additionally be identified with a GTIN |
| FREE SAMPLES MUST BE MARKED? |
Not Specified |
|
EXEMPTED PRODUCT |
Free samples of pharmaceutical products, pharmaceutical products imported for personal use only, Medical Devices and Supplies, GSL Products |
| BARCODE SYMBOLOGY | GSl -128linear |  | |
| BARCODE CONTENTS | SSCC | ||
| PARENT-CHILD MAPPING AGGREGATION CAPTURE? | Yes |
| HOMOGENEOUS LOGISTIC UNIT |
Yes (SSCC) |
| HETEROGENEOUS LOGISTIC UNIT |
Yes (SSCC) |
| BARCODE SYMBOLOGY | GSl -128linear | | |
| BARCODE CONTENTS | SSCC | ||
| PARENT-CHILD MAPPING AGGREGATION CAPTURE? | Yes |
| HOMOGENEOUS LOGISTIC UNIT |
Yes (SSCC) |
| HETEROGENEOUS LOGISTIC UNIT |
Yes (SSCC) |
| SEND UNIT DATA TO GOVERNMENT REPOSITORY? | Yes |
| SEND UNIT DATA TO THIRD-PARTY REPOSITORY? | Yes |
| 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? | Tatmeen |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? | Yes (Domestic & Exports) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT? | No (Future) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT? | No |
| MANUFACTURER ACTIVITY REPORTED? | Yes |
| 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
