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Jordan Food and Drug Agency (JFDA) released the notice, extending the deadline for the requirement of implementing Data Matrix and serialization on secondary packaging for regulated pharmaceutical products until 30 September 2024
Table of Contents
Another extension
The situation is being rolled forward for another time this year.
The current deadline for achieving full implementation is September 30, 2024.
Unchanged Labelling Requirements
At least the requirement for product labelling and packaging stayed unchanged. The JFDA has established specific requirements to ensure consumer safety and information transparency. The requirements for pharma serialization in Jordan are based on GS1 standards.
In general, the barcode must contain the following information:
- Global Trade Item Number (GTIN)
- Serial Number (SN)
- Batch/ Lot number
- Expiry date
The human-readable part must include the same elements, as the manufacturing data (MFD) and National Healthcare Reimbursement Number (NHRN) are optional.
The products that require labelling are all human drugs, veterinary drugs and herbal and health products. intended to be placed on the Saudi market require barcoding according to the SFDA guideline. Exceptions are made only for the free samples, non-registered drugs ordered for specific patients, drugs cleared for personal use, and drugs that must be repackaged – non-finished products.
Background
Jordan`s journey toward the implementation of pharma serialization started in 2017. The full operationalization of the entire Jordanian Track & Trace system was set for the beginning of 2020. Since then a lot of changes have been made, including several extensions of this exact deadline.
Pharma Market Overview
According to official statements, exports of Jordan’s pharmaceutical industries and medical supplies sector increased by 3.8% during January-June 2024, compared to the same period last year. The segment “Exports”, with its three sub-sectors (human drugs or veterinary medicines, pesticides, and medical supplies), surged to about USD 522.09 (JD 370) million during the first half of 2024, compared to USD 502.33 (JD 356) million for the same period in 2023.
We will continue to follow the journey of Jordan towards traceability system establishment and update you.
Meanwhile, if you need more information regarding track and trace regulatory compliance in Jordan, schedule a free consultation with our expert >> communication@softgroup.eu
