Under the guidance of the African Medicines Regulatory Harmonization (AMRH) and the New Partnership for Africa's Development (NEPAD), delegates from national and regional economic communities (RECs) spanning Africa have endorsed a Call to Action for the "Africa Strategy for Pharmaceutical Traceability." Through this endorsement, they have affirmed their dedication to implementing measures aimed at enhancing the accessibility of high-quality medicines, ensuring enhanced tracking of products throughout the supply chain, and facilitating improved patient care. Embracing established global standards for pharmaceutical traceability in supply chains is envisioned to advance these objectives by fostering stronger regional regulatory alignment and facilitating global and national interoperability among supply chains and associated information systems.
Several African countries are making rapid progress in implementing pharmaceutical drug traceability measures. Approximately 25 African countries and six donor organizations have committed to utilizing GS1 standards to enhance supply chain integrity and combat counterfeit medicines within their borders.
Zambia Medicines Regulatory Authority (ZAMRA)
The strategic plan for 2022-2026 has been devised by ZAMRA to enhance the effective and efficient execution of the Authority's regulatory functions both domestically and internationally. Additionally, the Zambia Medicines Regulatory Authority (ZAMRA) has released a preliminary Guideline on the Identification and Labelling of Medicines and Allied Substances as well as Master Data Sharing for public review and input. This guideline aims to outline the criteria by which the Authority will mandate product labeling in support of their forthcoming pharmaceutical traceability system aligned with GS1 standards. It marks a crucial progression towards establishing pharmaceutical traceability systems.
In March 2023, ZAMRA released a Guideline outlining the implementation of GS1 standards for traceability of medicines.
As per the preliminary guideline, serialization requirements for secondary packaging necessitate the inclusion of a linear 2D Data matrix. This data carrier must encompass;
- GTIN,
- expiry date,
- batch number, and
- serial number.
Regarding aggregation, all tertiary pack logistic units must feature a GS1-128 barcode encoded with a Serial Shipping Container Code (SSCC).
Furthermore, alongside these guidelines, Zambia is actively establishing its master data platform, which will serve as the centralized repository for all product information within the country. This initiative is led by the Ministry of Health.
Timelines
The dates listed below are based on the official publication date of the traceability guideline in August 2023.
Labelling/Barcoding:
- GTIN, Expiration, and Lot
Imported Medicines: August 2025
Domestically Manufactured Medicines: August 2026
- Serial Number
Imported Medicines: August 2028
Domestically Manufactured Medicines: August 2028
- Master Data Provision
The obligation to furnish and submit master data for Identifying organizations (MAH, Manufacturing Site, Legal Entity) at the time of MA application.
Trade items: February 2025 (1.5 years post-publication of the traceability guideline).
The system will utilize;
- Global Trade Item Number (GTIN),
- Serial Number,
- Expiration Date, and
- Batch/Lot Number for tracking purposes.
The current Scope is for the following participants;
- All domestic manufacturers
- Wholesale pharmaceutical enterprises
- Medical institutions
- Pharmacies
Compliance
It is important for pharmaceutical companies to work closely with their supply chain partners and technology vendors to ensure that their serialization solutions comply with Zambia regulations and meet the required deadlines. Non-compliance with serialization requirements can result in penalties and delays in product registration and market access.
Reference:
https://www.zamra.co.zm/wp-content/uploads/2023/08/Guildlines-of-Traceability-of-Medicines.pdf
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 Zambia pharmaceutical serialization requirements.
Our team of experts strategizes and plans 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.
