Pharma
| REGULATORY AGENCY | Zambia Medicines Regulatory Authority (ZAMRA) |
| REGULATION NAME | Draft guidelines for product identification labeling and master data sharing. |
| COMPLIANCE DATES | This is Draft guideline for public review and comments.(30th November 2021) |
| APPLIES TO | This guideline shall apply to all medicines and allied substances which are meant for supply to the Zambian |
(Packaging which is in direct physical contact with the active ingredient)
| BARCODE SYMBOLOGY | NA |
| BARCODE CONTENTS | NA |
| SERIAL NUMBER RANDOMIZATION | NA |
| SERIAL NUMBER REUSE | Not Specified |
| HUMAN READABLE EXPIRY DATE FORMAT | Not Specified |
| BARCODE DATA ENCODING | Not Specified |
| PRODUCT CODE NOTES | Not Specified |
| FREE SAMPLES MUST BE MARKED? | Not Specified |
(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 | Not Specified |
| SERIAL NUMBER REUSE |
Not Specified |
| HUMAN READABLE EXPIRY DATE FORMAT |
Not Specified |
| BARCODE DATA ENCODING |
GS1 Standards |
| PRODUCT CODE NOTES |
An additional barcode according to the GS1 Specifications, besides a GS1 Data Matrix for the identification of the secondary package in dispensing is allowed (e.g., use of the EAN-13 for retail purposes). The GTIN for the identification of the product in both barcode symbols, however, shall be the same. Placing the unique identifier on the secondary package by means of stickers is acceptable During the grace period for implementation of the unique identifier and When no legal and/or technically feasible alternative exists, as agreed upon between the Marketing Authorization Holder (MAH) and ZAMRA |
| 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 (Zamra) Product Master |
| SEND UNIT DATA TO THIRD-PARTY REPOSITORY? | As applicable |
| SEND UNIT DATA TO TRADING PARTNER? | As applicable |
| SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY? | Not Specified |
| SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY? | As applicable |
| SEND AGGREGATION DATA TO TRADING PARTNER? | As applicable |
| WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION? | Zambia Medicines Regulatory Authority – Zamra |
| 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 |
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For Further Information, please contact our Compliance Team at info@kevision.in
