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Guinea-Bissau Regulatory

Regulatory For

Guinea-Bissau

Guinea-Bissau Pharma Serialization & Traceability

Regulatory Agency
  • Primary authority: Autoridade Reguladora de Farmácia, Laboratório e Medicamentos (ARFAME)
  • Works under the Ministry of Public Health.
Regulation Name No standalone serialization regulation currently enacted. Oversight governed under national pharmaceutical regulatory framework and anti-counterfeit provisions.
Compliance Dates Manufacturers and Marketing Authorization Holders (MAHs)
  • By 15 November 2025: Register in the National Traceability System and submit product and location master data.
  • By 19 March 2026: Implement serialization of primary packages (SGTIN) with GTIN, lot number, and expiration date. Data must be submitted through GS1 EPCIS (Commission, Ship).
  • By 19 September 2026: Extend serialization to secondary and higher packaging (SSCC) and report aggregation data via GS1 EPCIS (Commission, Aggregate, Ship).

Distributors and Dispensers (Importers, Wholesalers, Pharmacies, Hospitals, Clinics)
  • By 30 November 2025: Complete registration and submit master data.
  • By 18 December 2025: Establish connectivity with the National Traceability System (API or manual interface).
  • By 19 September 2026: Comply with primary package serialization reporting.
  • By 19 September 2027: Extend compliance to secondary and logistic unit packaging, reporting via GS1 EPCIS (Receive, Ship, Dispense, Aggregate, Disaggregate).
Applies to Covered:
  • All human pharmaceutical products
  • Registered products
  • Donated medicines
Exemptions:
  • Personal import medicines
  • Non-registered emergency products
  • Promotional samples
  • Blood products
  • Traditional / homeopathic medicines
  • Extemporaneous preparations
However, movement tracking may still be required.

Secondary Packaging

Barcode Symbology GS1 2D DataMatrix
Barcode Content The unique identifier must follow the GS1 General Specifications and include:
  • GTIN (Global Trade Item Number)
  • Batch/Lot number
  • Expiration date
  • Serial number
Serial Number Randomization Not applicable – serialization not mandated.
Serial Number Reuse Not applicable.
Human Readable Expiry Date Format Required on packaging per standard labeling rules (Day/Month/Year or Month/Year depending on product).
Barcode Data Encoding No mandated GS1 DataMatrix encoding requirement.
Product Code Notes Importers typically use GS1 GTINs for commercial distribution, but this is not a government serialization mandate.
Free Samples must be marked? Samples must comply with general labeling laws; no serialization marking requirement.

Tertiary Packaging

Barcode Symbology Tertiary packages/logistic units: encoded in a GS1-128 linear barcode and/or 2D barcode.
Barcode Contents Identified with an SSCC (Serial Shipping Container Code)

Aggregation Data Capture

Parent-Child Mapping Aggregation Capture? No

Data Exchange

Send Unit Data to Government Repository? AVG Pharmaceutical Traceability Hub (AVGroupHub)
Send Unit Data to Third-Party Repository? Not Specified
Send Unit Data to Trading Partner? Commercial practice only (not regulatory serialization).
Send Aggregation Data to Government Repository? Not Specified
Send Aggregation Data to Third-Party Repository? Not Specified
Send Aggregation Data to Trading Partner? Not Specified

Authentication

Who Offers Data Repository for Authentication? No national pharmaceutical serialization repository currently operational.
Manufacturers Must Register Shipments in Repository? Not Specified
Downstream Trading Partners Must Authenticate on Receipt? Not Specified
Downstream Trading Partners Must Authenticate on Shipment? Not Specified

Government Reporting

Manufacturer Activity Reported? Import and distribution reporting required under general pharmaceutical control laws (non-serialization).
Downstream Trading Partner Activity Reported? Distribution records required for inspections; no electronic serialization reporting system.
Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

Disclaimer

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

About Kevision Systems

Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.

For Further Information, please contact our Compliance Team at info@kevision.in

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