Ghana

Regulation name

Ghana Pharmaceutical Traceability Strategy (2022) & FDA traceability guidelines (2023)

Serialization status

In progress – national traceability strategy published in 2022; pilot tracking projects active since 2023; unit-level serialization not yet mandatory

Country population

~32 million

Alert requirement: Not yet active –GFDA developing event capture and alerting features within national system

Aggregation requirement: Planned but not enforced – unit→case→pallet aggregation included in roadmap

Track & Trace requirement: Planned – phased implementation; full end-to-end traceability expected post-2025

Official governing body: Ghana Food and Drugs Authority (GFDA)

Implementation deadline / enforcement date: No fixed deadlines published; pilots ongoing with guidelines recommending gradual rollout post-2023

Serialization type / level: Planned GS1 DataMatrix on secondary; tertiary packaging to follow as system matures, Secondary packaging requires GTIN, Batch, Expiry; Serial included in later phases; tertiary SSCC

MAH / CMO responsibilities: MAH or authorized delegates will upload data during phased rollout

Serialized product scope: Phase 1 covers essential medicines; later phases include full Rx and OTC coverage

Penalties for non-compliance: Not defined yet; FDA guidelines indicate enforcement will follow national rollout stages

Repackaging rules: Not specified; presumed to align with GS1 global practice requiring re-serialization after repackaging

Serialization exemption rules: No written exemptions; small primary packs may be practical exceptions pending formal policy

Market coding requirements:

Planned GS1 DataMatrix on secondary units (GTIN + lot + expiry + serial when phased); tertiary SSCC proposed

Spanish