A Regulatory Shift for the Healthcare and Pharmaceutical Sector
The regulatory landscape governing medicines and medical devices in Lesotho has now formally changed.
The Minister of Health, Mr Selibe Mochoboroane, has officially brought the Lesotho Medicines and Medical Devices Control Authority Act, 2023 (Act No. 6 of 2023) into operation, with effect from 1 March 2026.
This marks a significant milestone in Lesotho’s healthcare regulatory framework and signals a move toward stricter oversight, improved public health safeguards, and alignment with continental regulatory standards.
Background and Previous Publication
Mayet & Associates Inc. previously published a detailed article analysing the Lesotho Medicines and Medical Devices Control Authority Act, 2023 at the time of its enactment.
That article remains a useful resource for understanding the substantive provisions and regulatory framework introduced by the Act and can be accessed here:
👉 https://zmayetlaw.co.ls/lesotho-medicines-and-medical-devices-control-authority-act-2023/
This refresher serves to highlight that the Act has now officially come into operation, with immediate legal effect.
What Has Changed?
While the Act was enacted in 2023, it had not yet taken legal effect.
With the commencement notice now in force, the entire regulatory framework is operational, meaning that:
- Medicines and medical devices are now formally regulated under a central authority
- Compliance is no longer prospective, it is legally required
- Regulatory enforcement mechanisms can now be implemented in practice
Establishment of the Regulatory Authority
The Act establishes the Lesotho Medicines and Medical Devices Control Authority, which is now responsible for:
- Regulating medicines, medical devices, and related products
- Overseeing registration and approval processes
- Licensing:
- Manufacturers
- Distributors
- Pharmacies and premises
- Personnel handling medical products
This introduces, for the first time, a centralised and structured regulatory body for the sector.
Mandatory Registration and Approval
A key implication of the Act now being in force is that:
- No medicine or medical device may be lawfully sold, distributed, or marketed without approval
- Registration is subject to strict criteria:
- Safety
- Quality
- Therapeutic efficacy
Testing and quality assurance will be conducted through:
- The National Pharmaceutical Quality Control Laboratory, or
- Other accredited laboratories
Licensing and Compliance Requirements
The Act introduces comprehensive licensing requirements, including:
- Registration of all medical products
- Licensing of:
- Manufacturing facilities
- Distribution channels
- Retail outlets
- Regulation of professionals involved in handling medical products
This represents a shift from a previously fragmented system to a fully regulated compliance environment.
Strengthened Enforcement and Market Control
The Act directly addresses longstanding risks in the sector, including:
- Circulation of substandard and counterfeit medicines
- Misleading or false advertising of medical products
- Unregulated herbal products
- Unauthorized clinical trials
The Authority now has powers to:
- Recall unsafe products
- Prohibit the sale or distribution of non-compliant medicines
- Monitor adverse effects through pharmacovigilance systems
Inspections, Monitoring and Pharmacovigilance
A robust enforcement framework is now operational, including:
- Appointment of:
- Inspectors
- Analysts
- Monitoring of:
- Product safety
- Manufacturing standards
- Implementation of pharmacovigilance, which includes:
- Detection and assessment of adverse drug reactions
- Ongoing safety monitoring
Penalties and Legal Consequences
With the Act now in force, non-compliance carries legal consequences, including:
- Fines
- Regulatory sanctions
- Possible closure of non-compliant operations
Importantly, the Act also provides for:
- Appeal mechanisms for parties aggrieved by decisions of the Authority
Alignment with the African Union Model Law
Lesotho is among 12 African countries that have adopted the African Union Model Law on Medical Products Regulation.
The commencement of this Act demonstrates Lesotho’s commitment to:
- Improving access to safe and effective medicines
- Combating counterfeit and substandard products
- Harmonising regulatory standards across the continent
What This Means for Businesses
Pharmaceutical companies, importers, distributors, and healthcare providers must now:
- Ensure immediate compliance with registration requirements
- Review product portfolios for regulatory approval status
- Confirm that:
- Premises are licensed
- Personnel are authorised
- Prepare for regulatory inspections and audits
Failure to comply may result in serious operational and legal risks.
Conclusion
The coming into operation of the Lesotho Medicines and Medical Devices Control Authority Act, 2023 marks a transformative shift in Lesotho’s healthcare regulatory environment.
It introduces a modern, structured, and enforceable framework designed to:
- Protect public health
- Improve the quality of medical products
- Align Lesotho with international best practices
For stakeholders in the healthcare and pharmaceutical sectors, the message is clear:
compliance is no longer optional, it is now a legal imperative.