Online Reporter
Sikhumbuzo Moyo, Senior Reporter
THE Medicines Control Authority of Zimbabwe (MCAZ) has released new guidelines to ensure the traceability of all medical products manufactured, imported, exported, advertised, sold, distributed or used within the country.
In a circular, MCAZ’s director-general, Mr Richard Rukwata, revealed that the Guidelines for Implementing Traceability for Medical Products in Zimbabwe (MCAZ/LED/GL-22) came into effect on 18 July.
The circular was addressed to manufacturers, wholesalers, pharmacies, industrial clinics and dispensing medical/veterinary practitioners.
“These guidelines apply to all medical products that are manufactured, imported, exported, advertised, sold, distributed, or used in Zimbabwe and are aimed at ensuring that such products are traceable throughout the entire supply chain,” reads the circular.
It said the traceability framework is expected to reduce the circulation of falsified medicines, strengthen recall mechanisms, and promote public confidence in the quality of medical products available on the market.
The Authority said implementation will be conducted in a phased approach, with the first phase running from 0-12 months and these are pilot projects targeting high-risk products with selected manufacturers and distributors, as well as unregistered medicines imported in bulk.
The second phase, running from 12-36 months, will see a gradual rollout across the pharmaceutical supply chain and finally, the third phase will be full national implementation and regulatory enforcement.
The Authority said key requirements include placement of unique identifiers on medical product packaging, use of GS1-compliant data carriers such as Data Matrix, GS1-128, electronic data sharing and traceability reporting by all supply chain actors, label printing requirements, including human-readable interpretations (HRI) and master data submission to the Authority.
“All manufacturers, importers, wholesalers, retailers, healthcare institutions, and other relevant entities are therefore required to comply with the provisions of these guidelines,” said the Authority.
It warned that non-compliance shall be subject to regulatory action as provided for under the Medicines and Allied Substances Control Act (Chapter 15:03) and SI 150 of 1991.
According to the circular, MCAZ will provide technical assistance, stakeholder training, and regular updates to facilitate the smooth adoption of the traceability framework.
These guidelines come against the background of the Authority having embraced cutting-edge portable technology to combat substandard and falsified medicines, which continue to be of serious concern.
The authority is now using handheld Raman and Near-Infrared (NIR) spectrometers to rapidly verify the authenticity of medicines — without opening packaging or sending samples to a laboratory.
“Substandard and falsified (SF) medicines remain a critical public health concern, but MCAZ is leveraging cutting-edge portable technology to strengthen frontline defences. Handheld Raman and Near-Infrared (NIR) spectrometers are now being used to rapidly verify the authenticity of medicines — without opening packaging or sending samples to a laboratory,” said the Authority.
spectrometers use laser light to generate a unique chemical “fingerprint” of a drug, while NIR spectrometers analyse its internal structure using near-infrared light.
These compact tools deliver fast, reliable results in minutes, are easy to operate in the field, and are already proving invaluable at pharmacies, clinics, and border checkpoints,” said the Authority.
By integrating these technologies into its quality surveillance efforts, MCAZ is striving to ensure that only safe, effective medicines reach the public.
