Armenia's pharmaceutical traceability is governed by a robust legal framework anchored in the Law on Goods Labelling and the comprehensive Law "On Medicinal Products." The Ministry of Health's Order N02-N establishes detailed requirements for pharmaceutical labelling and traceability, ensuring that medicinal products, pharmaceutical substances, and related materials comply with both national and EAEU standards. This harmonized approach facilitates seamless cross-border trade while maintaining stringent safety protocols throughout the pharmaceutical supply chain.

The state-operated e-Mark system serves as Armenia's cornerstone for electronic product marking and traceability, managed by the State Revenue Committee. This centralized platform generates, assigns, and monitors unique product codes using Data Matrix technology, enabling comprehensive end-to-end tracking of pharmaceutical products. The system's integration with EAEU partners ensures interoperability and supports Armenia's commitment to regional regulatory harmonization while maintaining sovereign control over domestic pharmaceutical oversight.

Armenia employs a strategic phased approach to traceability implementation, initially targeting high-risk product categories before expanding to pharmaceuticals. This methodical rollout allows for system refinement and stakeholder adaptation while building toward comprehensive pharmaceutical serialization. The Ministry of Health has established pilot programs and implementation timelines that align with EAEU practices, ensuring a smooth transition to mandatory pharmaceutical traceability without disrupting existing supply chains.

The regulatory framework encompasses stringent licensing requirements for pharmaceutical wholesalers and mandatory certificates of activity for proper medicine distribution. State inspections and control mechanisms actively monitor compliance, with penalties for violations ensuring adherence to traceability regulations. Registration certificates for medicinal products require five-year renewals, creating ongoing accountability and maintaining current product information within the traceability system.