The Ministry of Health (MOH) safeguards public health in Lesotho and regulates a mixed system of public and private provision. For investors, MoH provides the pathway for licensing private facilities (clinics/day hospitals), laboratories, pharmacies/wholesale distributors; for importing and distributing medicines and medical devices; and for partnering with the public sector on diagnostics, supply chains, and digital health. This brief also covers regulation of controlled substances (narcotics/psychotropics) and licensing for medicinal cannabis cultivation, processing, and export.
Regulatory Framework – Scope and Coverage
Scope includes:
Licensing/inspection of private facilities and labs;
Professional registration via medical, nursing and allied health councils;
Regulation of medicines/medical devices, import permits, market authorisation and pharmacovigilance;
Public health programmes and IPC;
Health information systems and data governance;
PPP/outsourcing for diagnostics, facility services and IT; and
Regulation of controlled substances and medicinal cannabis (with security/customs coordination).
Regulatory Map: Who Does What
Area
Primary Authority / Instrument
What it Means for Investors
Private facilities and labs
MoH licensing and inspection; facility standards/EHS
Authorisation to establish and operate clinics, day hospitals and labs.
Professional registration
Health Professions Councils
Licensing of clinicians and allied health staff.
Medicines and devices
MoH / NDSO regulations
Import permits, wholesale authorisations and post‑market surveillance.
Public health and IPC
MoH programmes/directives
Compliance with IPC protocols and notifiable disease reporting.
Health information and data
MoH HIS governance; privacy rules
Standards for EMR, reporting and data protection.
Controlled substances
MoH (Drug Control) with Police/Justice
Scheduling, licences, quotas, storage security, registers and audits.
Controlled Substances – Narcotics and Psychotropics
MoH regulates controlled substances consistent with national law and international conventions. Businesses handling scheduled narcotics/psychotropics must obtain specific licences and maintain strict controls to prevent diversion.
Key elements include: licensing and scope; secure storage; prescribing/dispensing controls; import/export permits and quotas; mandatory registers, reconciliations and reporting; and supervised destruction of expired stock.
Requirement
What Investors Must Demonstrate
Typical Evidence
Licensing and scope
Licence for manufacture, import/export, wholesale or dispensing of scheduled substances
Real‑time/daily registers; periodic submissions to MoH
Bound registers or e‑logs; monthly/quarterly reports
Audit and inspection
Unannounced inspections and reconciliations
Inspection reports; inventory reconciliations
Disposal
Approved destruction process with witness
Disposal permits; certificates of destruction
Medicinal Cannabis – Licensing and Compliance
Medicinal cannabis projects require multiple approvals: cultivation and processing licences, security approvals, and export permits. Expect seed‑to‑sale tracking, agronomic/manufacturing standards (GACP for cultivation, GMP for processing), accredited laboratory testing, and strict diversion controls. Exports require evidence of lawful import by the destination country and compliance with international controls.
Stage
Key Requirements
Notes / Investor Considerations
Pre‑application
Site control; zoning/land approvals; environmental screening; project concept
Operators must comply with MoH data governance requirements (secure PHI handling, role‑based access, consent where required) and report into national systems (e.g., DHIS‑style platforms). Systems should support audit trails, encryption in transit/at rest, and continuity planning.
