Zimbabwe Serialization Update: What Pharma Companies Must Know

On July 18th, Zimbabwe took an important step toward improving public health and combating counterfeit medicines by introducing new traceability guidelines for medical products. This targets pharmaceutical manufacturers, importers, exporters, distributors, and other relevant stakeholders.

As a pharma company following this framework, you can actively track your products from production to the end-consumer, reducing the risk of falsification, simplifying recall processes, and earning your customers’ trust.

The GL-22 guideline introduces a complete end-to-end system of pharmaceutical traceability based on serialization, data capture, and real-time reporting. Its core features include:

• Unique identifiers (GTIN, batch/lot number, expiry date, serial number) are applied to all packaging levels 
• Use of GS1 Data Matrix barcodes for machine-readable encoding 
• Centralized data sharing with MCAZ for real-time monitoring 
• Enforcement of minimum print quality, data structure, and barcode placement rules 
• Master data registration using Global Location Numbers (GLN) 
• Capturing and sharing supply chain events such as manufacturing, distribution, sale, or recall 

The goal is to reduce the production and distribution of falsified medical products, improve recall systems, protect patients, and rebuild trust in the pharmaceutical system.

The implementation of this guideline shall follow a phased approach:

• Phase I (0–12 months): Pilot projects with selected manufacturers and distributors

identified for high-risk products.

• Phase II (12–36 months): Gradual rollout across the supply chain.
• Phase III (36–60 months): Full implementation and regulatory enforcement.

MCAZ will provide periodic updates, technical assistance, and training during the transition 

period. 

Serialization and standardized product coding reduce the risk of counterfeit medicines entering the legal supply chain. With traceability in place, you gain full visibility over product movement—from manufacturing to the point of sale. Improving recall speed and accuracy helps reduce financial loss and safeguard the brand’s reputation.

Mandatory data sharing and event reporting bring real-time insights into inventory, expiry dates, and logistics performance. Aligning with GS1 global standards also simplifies compliance in export markets where similar systems are already in place.

Overall, the Zimbabwe pharmaceutical traceability regulation:

• Reduces revenue losses from counterfeit products 
• Gives full visibility across the supply chain by improving recalls 
• Aligns with global serialization standards 
• Strengthens regulatory oversight and public confidence 

Companies already active in serialized markets like the EU or Saudi Arabia will find Zimbabwe’s framework familiar, as it follows established GS1 specifications and global best practices.

Already working with serialization?

 We’ll help you align your existing systems with the MCAZ traceability requirements without disrupting your current workflows.

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