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21 Oct

[Blog] Traceability of Medicines in Guinea-Bissau: Key Regulatory Deadlines and Requirements

by Milena Atanasova
in Blog, news
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Guinea-Bissau: Key Regulatory Deadlines and Requirements

 

On 19 September 2025, the Government of Guinea-Bissau officially established its national pharmaceutical traceability system – the AVG Pharmaceutical Traceability Hub.
The initiative was launched under Dispatch No. 31/GMSP/2025 and the Joint Dispatch of the General Health Inspection Office (IGAS) and the Regulatory Authority for Pharmacy, Laboratory and Medicines (ARFAME), published in October 2025.

The system introduces mandatory digital Track & Trace controls to verify the authenticity and origin of all medicines distributed in the country. The platform will open in October 2025 for registration of manufacturers, importers, distributors, and dispensers. The official go-live is set for March 2026.

 

Implementation Timeline

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).

 

Scope of Application

 

The regulation covers all pharmaceutical products intended for human use, including registered and donated products, except:

 

  • Products imported for personal use
  • Non-registered products ordered by authorized institutions
  • Samples for regulatory or promotional purposes
  • Blood and blood components
  • Homeopathic and traditional medicines
  • Extemporaneous preparations

 

Exempted products remain subject to movement registration in the National Traceability System unless specifically waived by the Authority.

 

Serialization and Data Structure

 

The unique identifier must follow the GS1 General Specifications and include:
  • GTIN (Global Trade Item Number)
  • Batch/Lot number
  • Expiration date
  • Serial number
Identifiers must appear both in human-readable and machine-readable format:
  • Secondary packages: encoded in a 2D DataMatrix
  • Tertiary packages/logistic units: encoded in a GS1-128 linear barcode and/or 2D barcode
  • Logistic units: identified with an SSCC (Serial Shipping Container Code)
All supply chain participants must record and communicate traceability data to the national system.

Registration and Connectivity

 

The National Traceability System portal will be accessible from 27 October 2025 at https://guinea-bissau.avgrouphub.com
Steps for registration:
  1. Complete the training section (Resources – Trainings).
  2. Fill in the sign-up form with company details, GLN, and representative information.
  3. Verify registration via the email confirmation link.
  4. Receive system confirmation within 72 hours.
Entities failing to register or connect will not be authorized to manufacture, import, distribute, or dispense medicines.
The Guinea-Bissau initiative follows similar national systems in Nigeria, Ghana, and Kenya, which are also aligned with GS1 EPCIS and World Health Organization (WHO) guidelines for medicine traceability.

Official Sources