Southern African Development Community (SADC) Track & Trace Requirements
Established in 1992, the SADC is a Regional Economic Community (REC) with 16 member states, including South Africa. Like other RECs, the SADC is developing pharmaceutical regulations for its member states, as well as monitoring the progress of the African Medicines Agency, which is working toward continent-wide harmonization of pharmaceutical regulations.
About SADC Track and Trace Requirements
The SADC member states are Angola, Botswana, Comoros, Democratic Republic of Congo, Eswatini, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Tanzania, Zambia, and Zimbabwe.
South Africa has the most established regulatory system; it seems the other SADC countries will adopt the same guidance, though this is not certain. 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).
As laid out in the Medicines and Related Substances Act, SAHPRA is responsible for “authorising, regulating, controlling, restricting or prohibiting the registration, manufacture, modification, importation, exportation, storage, transportation, sale or use of any medical device, IVD or class of medical devices, IVDs or medicines in respect of its safety, quality and efficacy.”
The proposed phased implementation of product identification and serialization began in December 2018 and could conclude in June 2022; however, the pandemic and other factors may affect this timeline. For serialization, a GTIN, batch/lot numbers, expiry date, and serial number are required in a 2D DataMatrix code. Aggregation and reporting to SAHPRA or another government agency does not seem to be required.
rfxcel Meets SADC Serialization & Traceability Requirements
rfxcel Is Your Partner for SADC Compliance
Our team will partner with you to meet SADC regulatory requirements and transform business value with a transparent digital supply chain. With dedicated track and trace solutions from rfxcel, you can safeguard your products and brand reputation by ensuring all items are legitimate, marked, and fully compliant with SADC laws.
rfxcel’s Team: Compliance, Visibility & Support
rfxcel’s team will help you achieve and maintain SADC compliance by bringing end-to-end visibility to your supply chain.
rfxcel will develop a fully validated implementation plan tailored to your needs and designed specifically for SADC countries. Our systems operate in local languages, local currency, and processes, easing the compliance burden for companies in any industry. Our goal is to increase company value through insightful and precise data by automating and digitizing workflows.
rfxcel provides 24/7 support to all our customers. We assign a dedicated support team member to our customers so we can quickly and thoroughly resolve any issues that arise.
Secure Your Supply Chain with rfxcel Traceability System
Our award-winning Traceability System is a fully customizable platform that simplifies and accelerates compliance and increases supply chain visibility no matter where you do business. It also integrates seamlessly with your existing systems and enhances scalability by letting you add new features quickly.
Find out more about our SADC compliance solutions and visit our blog for more about the African supply chain, including the eight RECs and the push for continent-wide harmonization through the African Medicines Agency.
Your value beyond compliance with rfxcel
- Digitize and centralize your entire supply chain in one elegant, easy-to-use, intuitive platform
- Enhance performance and reduce processing time in multiple languages
- Leverage IoT technology to gain new real-time insight into and control of your supply chain
- Trace your products forward and backward
- Maintain historical information for a batch or individual product with continuous review and supply chain optimization
- Drive growth by lowering costs and risks, eliminating inefficiencies, and tracking all activity anywhere in your supply chain, including among suppliers, distributors, and 3PLs
- Integrate with any trading partner