Introduction
Ministry of Health (MoH) in Kuwait published Circular in 2022 regarding the track and trace requirements for pharmaceutical medicines. However as of now there is no traceability requirements but it is stated the from January 2024 onwards all pharmaceutical products sold in Kuwait must have a GS1 DataMatrix with 4 data elements. Kuwait MoH have planned to implement GS1 standards for serialization, aggregation and barcoding.
Product Identification
Following 4 data elements to be encoded in 2D barcode. To facilitate the visual correct reading control Human-Readable Information (HRI) is applied along with a 2D barcode:
- GTIN: N2 + N14
- Batch number: N2 + Maximum of 20 alphanumeric characters.
- Expiration date: Represented in YYMMDD.
- Unique Serial number: N2 + up to 20 alphanumeric characters.
Timelines:
1st January-December 2023: Local agents to submit master data to GS1 Kuwait.
1st January 2024: All pharmaceutical products present in Kuwait supply chain must comply with GS1 DataMatrix with 4 data elements.
* Technical details on master data submission to GS1 Kuwait is awaited.
Gulf Health Council (GHC) is an active organization in GCC of which Kuwait is an active member. It is expected that GHC has announced to initiate Electronic Patient Information Leaflet “e-PIL” project. The agenda of e-PIL is to provide updated, electronic, and harmonized information about medicines throughout the GCC region.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the Jordan pharmaceutical serialization requirements.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
