17 Jun

[Blog] Algeria Moves Forward on Pharmaceutical Traceability

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Algeria Advances Toward Pharmaceutical Traceability with New GS1 Guidance

Published: June 2025 | Author: SoftGroup Editorial Team

Algeria is entering a new phase in pharmaceutical regulation with the release of a draft circular and GS1 implementation guideline at the end of 2024. These documents outline the technical conditions for the importation of medicines and medical devices for human use—marking a pivotal shift toward full pharmaceutical traceability in the country.

While the draft circular does not yet include a fixed implementation date, the authorities have confirmed that the requirements will apply from the date of signature. For pharmaceutical companies operating in or exporting to Algeria, this signals the need to prepare without delay.

A Strategic Move Toward Global Compliance

Alignment with Global Traceability Standards

The GS1 guideline places Algeria on the path to aligning with international best practices in serialization and product verification. The key data identifiers required under the upcoming regulation include:

GTIN (Global Trade Item Number): To uniquely identify each product
Serial Numbers: For unit-level traceability and counterfeit prevention
Batch/Lot Numbers & Expiry Dates: Essential for recall readiness and patient safety
2D Data Matrix Barcodes: For efficient, high-density data capture throughout the supply chain

This alignment reflects Algeria’s ambition to enhance both market surveillance and supply chain transparency, mirroring regulatory frameworks already in place across the EU, MENA region, and other regulated markets.

National Pilot Project Starts in 2025

As Algeria prepares for full-scale implementation, a national pilot project is set to launch in early 2025. This initiative will test the technical and operational readiness of stakeholders, including manufacturers, importers, and health authorities.

At SoftGroup, we view this as an essential phase—one that not only prepares the pharmaceutical ecosystem for compliance but also sets the foundation for long-term digitalization and automation.

What This Means for Pharmaceutical Stakeholders

Whether you’re a Marketing Authorization Holder, CMO, or local distributor, the Algerian traceability roadmap brings new responsibilities—but also new opportunities:

Ensure readiness for GS1 serialization and reporting
Evaluate your existing IT and line-level capabilities
Plan for onboarding support, training, and partner alignment
Take advantage of the pilot phase to validate systems and workflows

SoftGroup has deep experience supporting both national authorities and pharma companies across traceability rollouts—from regulatory gap analysis to end-to-end software implementation. Our solutions are fully GS1-compliant and already operational in markets with similar frameworks.

Get Ready for Algeria’s Traceability Future

Algeria’s regulatory push reflects a broader global shift toward connected, transparent, and secure pharmaceutical supply chains. Now is the time to evaluate your readiness and take proactive steps to remain compliant and competitive.