FAQs
Frequently Asked - Find answers to common questions about Track & Trace
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Yes, registration is required per the Pharmaceutical Products Traceability Directive No 43/2019 and related directives issued by EFDA.
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Yes. All supply chain participants must obtain a Global Location Number (GLN) to identify their organizations and key operational locations per the traceability directive.
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Invoicing Companies and Marketing Authorization Holders must register with GS1. GLN and GCP information can be found using the GS1 Lookup Directory and GTIN Management site.
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Aggregation defines parent-child barcode relationships, allowing receivers to scan one code and understand complete shipment contents. Serialized GTINs are used at unit and case levels; SSCC applies to pallets.
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The registration process involves administrative registration and technical onboarding, including TEST hub connection and PRODUCTION hub go-live after demonstrating compliance.
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The Invoicing Company is the entity handling invoicing, which may be the manufacturer or a separate company managing pharmaceutical distribution.
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Yes, all legally registered Invoicing Companies must be EFDA-approved, complete signup, sign participation agreements, and pay required fees.
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Complete MAH approval with EFDA, register with GS1, obtain GLN and GTIN, visit EFDA-MVC portal, complete the application form, finalize participation agreement, then begin technical onboarding.
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