MAH vs LTR: Pharmacovigilance Responsibilities in Kenya
Foreign pharmaceutical companies registering products in Kenya frequently operate through a Local Technical Representative (LTR) rather than a direct local entity — and understanding exactly where MAH responsibility ends and LTR responsibility begins is one of the more commonly misunderstood parts of PPB compliance.
What the MAH remains responsible for The MAH holds ultimate legal accountability for product safety and regulatory compliance, even when operational PV activities are delegated locally. Registration status, product-level obligations, and financial/contractual accountability to the PPB typically remain with the MAH.
What the LTR typically handles
- Providing or hosting the locally-registered QPPV
- Day-to-day liaison with the PPB
- Local submission of PSURs, ADR reports, and other regulatory correspondence
- Representing the product during PPB inspections
Three authority structures worth knowing Kenyan pharmacovigilance compliance typically maps onto one of three structures: a standalone LTR managing multiple MAH relationships, a MAH operating under an LTR for full compliance delegation, or a standalone MAH with its own local infrastructure. Each structure has different practical implications for who a PV platform's user access needs to serve — an LTR managing five MAHs, for example, needs strict separation between each MAH's data even when using shared tooling.
Why this distinction matters for choosing PV tooling A platform built only for single-MAH use often breaks down for LTRs managing multiple MAH relationships simultaneously, since data segregation and access control between accounts becomes a compliance issue in itself, not just a UX inconvenience.
PvSentinel supports standalone LTR, MAH-under-LTR, and standalone MAH structures
FAQ
Can an LTR be held liable for a MAH's non-compliance? Yes — PPB guidelines note sanctions can apply to the MAH, LTR, manufacturer, or QPPV depending on where a compliance gap originated. Does every foreign MAH need an LTR? This depends on the MAH's local presence and structure — many opt for an LTR specifically to satisfy the local QPPV requirement without establishing a full local entity.