03 Nov

[Blog] Serialization Now Mandatory in Algeria: What the New 2025 Decree Means for Pharma Importers

Table of Contents

A Major Compliance Shift: Algeria Makes Serialization Mandatory

On October 12, 2025, Algeria’s Ministry of Pharmaceutical Industry introduced a decisive regulatory step forward. The Ministerial Decree No. 25 (Arrêté N°25 du 12 Octobre 2025), published in the Official Journal of the Algerian Republic, now makes serialization mandatory for all human medicines imported into the country.

This new measure is part of Algeria’s broader push to modernize pharmaceutical regulation and aligns with international efforts to enhance medicine traceability and patient safety.

What the Decree Covers: Key Compliance Requirements

The decree sets clear technical conditions for the importation of pharmaceuticals and medical devices, with two primary objectives:

Ensure traceability and security of imported health products
Harmonize with international standards, including GS1-compliant Data Matrix barcoding

By January 1, 2027, all affected products must:

Feature a 2D Data Matrix code on each secondary packaging, encoding:

GTIN (Global Trade Item Number)
Unique serial number
Batch number
Expiry date

Include a tamper-evident device, confirming package integrity

These requirements apply to:

Prescription medicines
Reimbursable medicines

…and affect all stakeholders in the supply chain – manufacturers, importers, distributors, and logistics providers operating in the Algerian market.

What’s Next: Reporting to the Algerian National Track and Trace System

The decree also confirms that an additional official document will be issued by the end of 2025, specifying the reporting mechanism to Algeria’s National Track and Trace System. This upcoming obligation will clarify how data must be exchanged between supply chain partners and national authorities – an essential step for end-to-end compliance.

How SoftGroup Can Help

Whether you’re preparing for Algeria’s 2027 deadline or already operating in other serialized markets, SoftGroup provides full Level 2–5 serialization and aggregation solutions fully aligned with GS1 and international compliance requirements.

Azure-based serialization platform
Local regulation mapping
Fast implementation for new markets
Integration with customs and reporting systems

Official Sources of Information

Ministry of Pharmaceutical Industry (Ministère de l’Industrie Pharmaceutique – Algérie)
GS1 Standards for Serialization and Aggregation