Introducing the second article of the series on Africa’s Track and Trace Compliance landscape. In this paper we will look through the Track and trace systems in Zambia, Botswana and South Africa.
In late October 2021, the Zambia Medicines Regulatory Authority (ZAMRA) published a draft Guideline on Identification and Labelling of Medicines and Allied Substances and Master Data Sharing for public comments and feedback.
This document aims to guide how the Authority will require products to be labelled in support of their future pharmaceutical traceability system that is based on GS1 standards. This is an important step that needs to be taken in order to set up pharmaceutical traceability systems.
In December 2022 ZAMRA in collaboration with Management Development Division published a Strategic Plan for the period 2022-2026.
The ZAMRA Strategic Plan for 2022-2026 has been formulated to execute the Authority’s regulatory functions effectively and efficiently at both National and International levels.
To ensure that all medicines and allied substances conform to the set standards of quality, safety and efficacy throughout the supply chain, the Strategic Plan provides an operational framework which forms a critical component in the Authority’s execution of its mandate. The Plan spells out ZAMRA’s strategic focus in its vision, mission, core values, objectives and Strategies.
The Plan’s intended Strategic results are:
- to attain effective and efficient service delivery
- to ensure that all clients comply to set standards and regulations
- to enhance public confidence in the role of the Authority
In March 2023 ZAMRA published Guideline on traceability of medicines using GS1 standards.
According to the draft guideline, the serialization requirements for secondary packaging include placing a linear 2D Datamatrix.
The data carrier must include the following elements:
- Expiry date
- Batch number
- Serial number
Regarding the aggregation, all tertiary pack logistic units must include a GS1-128 barcode encoded with Serial Shipping Container Code (SSCC).
In addition to the guidelines, Zambia is also working on setting up its master data platform that will serve as the single source of truth for all product information in the country. This work is being championed by leadership from the Ministry of Health.
The Botswana Medicines Regulatory Authority was established by the Medicines and Related Substances Act of 2013 and commenced its operations in January 2018. The Authority’s primary role is to administer the Medicines and Related Substances Act, which is to regulate the supply chain of medicines, medical devices, and cosmetics in Botswana to ensure their quality, safety and efficacy.
BoMRA currently does not have a national track and trace system. However, such a traceability system was initiated with the support of the local Global Health and Supply Chain Management office.
In October 2021 BOMRA published its medicines traceability vision and strategy:
- Focus on strategic objectives and program benefits.(2021–2022)
- Definition of coding standards and master data architecture (.2022–2023)
- Deployment of initial software and requirements definition for traceability systems (2024).
The objective of this initiative will be to ensure both integrity in the local medicines supply chain and patient protection against the effects of substandard and falsified medicines. Later that year, leadership launched the traceability steering committee which will serve to provide guidance to the country’s efforts to set up pharmaceutical traceability.
In the report “Tracking Universal Health Coverage in the WHO African Region, 2022” Botswana is pointed out as one of the countries that shift its focus to delivering services through robust subnational health systems.
South Africa has well established regulatory system. In South Africa, the South African Health Products Regulatory Authority (SAHPRA) is in charge of monitoring, evaluating, investigating, inspecting, and registering health products, including drugs for human and animal use, devices, and in vitro diagnostic medical devices (IVDs).
The proposed phased implementation of product identification and serialization began in December 2018.
The deadline for Complete Pharmaceutical product serialization on secondary and tertiary level packaging was June 30, 2022.
For serialization, a GTIN, batch/lot numbers, expiry date, and serial number are required in a 2D DataMatrix code. These requirements apply to local pharma manufacturers and importers of pharmaceutical products.