Pharma
| REGULATORY AGENCY | EDA : Egyptian Drug Authority |
| REGULATION NAME | UDI Decree |
| COMPLIANCE DATES | The deadline for the use of the GTIN for all medical supplies that are being traded inside the local market is one year from the publication of the Decree. |
| APPLIES TO | All medical devices, their accessories and IVDs that will be supplied to the Egyptian market, except medical devices and IVDs for research use, or investigational, custom made. |
(Packaging which is in direct physical contact with the active ingredient)
| BARCODE SYMBOLOGY |
GS1 DataMatrix (inter alia, ID/linear bar code, 2D/Matrix bar code, RFID) |
| BARCODE CONTENTS |
|
| SERIAL NUMBER RANDOMIZATION | NA |
| SERIAL NUMBER REUSE |
No |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
UDI – PI |
| PRODUCT CODE NOTES |
Primary Level Packaging Is defined as the first level of packaging in direct contact with the product and marked with an AIDC (Automatic Identification and Data Capture) data carrier either on the packaging or on a label affixed to the packaging. It may consist of a single item or group of items for a single therapy such as a Kit. For packaging configurations that include a retail consumer trade item, primary packaging is a packaging level below the retail consumer trade item. |
| FREE SAMPLES MUST BE MARKED? |
Not Specified |
(Packaging which is in direct physical contact with the active ingredient)
| BARCODE SYMBOLOGY |
GS1 DataMatrix (inter alia, ID/linear bar code, 2D/Matrix bar code, RFID) |
| BARCODE CONTENTS |
|
| SERIAL NUMBER RANDOMIZATION | NA |
| SERIAL NUMBER REUSE |
No |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
UDI – PI |
| PRODUCT CODE NOTES |
Due to the wide variety of secondary level packaging configurations for medical devices, following is additional guidance. In the following examples, the outer carton is the secondary level packaging.
|
| 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? | Yes (EDA ) |
| 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? | EDA |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? | Yes (Exports & Import) |
| 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
