Armenia Delays Mandatory Serialization for Medicines with Crypto Codes Until 2026 – What This Means for Pharma Companies

 

The pharmaceutical industry in Armenia has been granted additional time to comply with mandatory serialization requirements. According to Government Decision No. 125-N, issued on February 6, 2025, the deadline for mandatory marking of medicines with crypto codes has been postponed to January 1, 2026. This regulation, which applies to a defined list of pharmaceutical products, aims to enhance supply chain security and traceability across the country.

 

This extension presents challenges and opportunities for pharmaceutical manufacturers and importers. While it provides more time for compliance, companies should not delay preparations. Implementing serialization is a complex process requiring the integration of hardware, software, and compliance workflows.

 

Who Needs to Comply?

 

The decision specifies that the following product categories, classified under Armenia’s Commodity Nomenclature of Foreign Economic Activity (CNFEA), will require serialization:

• 3002 41 000 0 (Certain blood fractions and immunological products) • 3004 (Medicinal products for therapeutic or prophylactic use) • 3006 30 000 0 (First-aid kits and emergency medical kits) • 3006 60 000 0 (Chemical contraceptives based on hormones or spermicides)

 

Although serialization is mandatory from January 1, 2026, the government allows voluntary adoption before this deadline. This means that proactive companies can gain an advantage by preparing early.

 

Immediate Action Required for Compliance

 

To ensure continued compliance and system access, pharmaceutical companies must take the following steps:

• Marketing Authorization Holders (MAHs) • MAHs that have not yet transitioned to the new API must expedite EPCIS data flow migration to the upgraded NHRA-MVC Traceability Hub.
• Please refer to the official guidance here: NHRA-MVC Upgrade Letter to MAHs • Distributors and Dispensers • NHRA-MVC will directly coordinate training, seminar invitations, and support to ensure a smooth transition.

 

E-Mark: The National Operator

 

The E-Mark national operator has been designated to oversee the serialization system. This entity will issue crypto codes, ensure data integrity, and maintain the national tracking system. Companies looking to implement serialization can contact E-Mark for technical details and process guidelines.

 

How Should Pharma Companies Prepare?

 

With serialization compliance being a significant shift, pharma companies, parallel importers, and distributors must take strategic steps to meet the requirements:

 

• Assess Readiness – Conduct an internal audit of existing systems and identify compliance gaps.
• Upgrade IT Infrastructure – Ensure ERP, WMS, and production systems can integrate with Armenia’s E-Mark platform.
• Implement Secure Data Exchange – Serialization success depends on real-time data integrity and secure business transactions across the supply chain.
• Train Teams – Serialization impacts multiple departments, including regulatory, supply chain, and IT. Training employees in compliance workflows is essential.

 

The Bigger Picture: Serialization as a Compliance Trend

 

Armenia’s move towards serialization follows a global trend in pharmaceutical track-and-trace regulations. Many countries, including Russia, the EU, and the US, have implemented strict traceability mandates to combat counterfeiting, improve patient safety, and enhance supply chain transparency. Companies operating across multiple markets should align their serialization strategies for seamless compliance.

While the postponement to 2026 provides additional time, it should not lead to planning delays. Serialization requires significant investment, IT adaptations, and regulatory coordination. Early compliance will allow businesses to avoid last-minute disruptions, enhance supply chain security, and gain a competitive advantage in the Armenian pharmaceutical market.

 

For more details, visit the official government decision:

 

Government Decree Link

Marking Rules Document

 

 

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