SADC Region

Regulation name

SADC Regional Pharmaceutical Traceability Harmonization Initiative

Serialization status

In progress – regional guidelines drafted since 2019; adoption underway with pilot projects in select member states, but serialization not yet mandatory

Country population

~350 million combined

Alert requirement: Not yet active – envisaged to be deployed via GS1-backed regional platform post-rollout

Aggregation requirement: Planned – unit→case→pallet aggregation requirement currently under guideline development; not yet enforced

Track & Trace requirement: Planned – ePedigree/EPCIS-style system being designed; full T&T expected following regional alignment

Official governing body: SADC Pharmaceutical Programme under Social & Human Development Directorate; collaborating with GS1 and national NMRAs

Implementation deadline / enforcement date: No regional mandate in place; pan-SADC traceability expected on staggered national timelines post-2023 pilot and harmonization

Serialization type / level: Plan: GTIN + SN + EXP + LOT on secondary; SSCC on tertiary; no country-specific codes defined

MAH / CMO responsibilities: MAHs or their designees (e.g., CMOs/3PLs) will transmit data to national/regional systems once operational; packaging labs prepare codes / MAH or delegated designee (e.g., CMO/3PL) transmits data; MAH retains full compliance responsibility.

Serialized product scope: All pharmaceuticals within SADC markets (Rx + OTC + medical devices) once national mandates are activated, Intended full-market scope (Rx and OTC); some pilot focus currently on essential medicines

SADC Region

Alert requirement: Not yet active – envisaged to be deployed via GS1-backed regional platform post-rollout

Aggregation requirement: Planned – unit→case→pallet aggregation requirement currently under guideline development; not yet enforced

Track & Trace requirement: Planned – ePedigree/EPCIS-style system being designed; full T&T expected following regional alignment

Official governing body: SADC Pharmaceutical Programme under Social & Human Development Directorate; collaborating with GS1 and national NMRAs

Implementation deadline / enforcement date: No regional mandate in place; pan-SADC traceability expected on staggered national timelines post-2023 pilot and harmonization

Serialization type / level: Plan: GTIN + SN + EXP + LOT on secondary; SSCC on tertiary; no country-specific codes defined

MAH / CMO responsibilities: MAHs or their designees (e.g., CMOs/3PLs) will transmit data to national/regional systems once operational; packaging labs prepare codes / MAH or delegated designee (e.g., CMO/3PL) transmits data; MAH retains full compliance responsibility.

Serialized product scope: All pharmaceuticals within SADC markets (Rx + OTC + medical devices) once national mandates are activated, Intended full-market scope (Rx and OTC); some pilot focus currently on essential medicines

Penalties for non-compliance: Not yet defined; enforcement frameworks to be established alongside national implementations

Repackaging rules: Not specified; GS1 global practices suggest re-serialization and aggregation apply to all repackaged units

Serialization exemption rules: None documented; small primary packs may be pragmatically exempt until national systems are in place

Market coding requirements:

Planned GS1 DataMatrix (GTIN + SN + EXP + LOT) on saleable units; harmonized barcoding standards under development