As at 2008, there were no legal provisions that require establishing the powers and responsibilities of the Medicines Regulatory Authority. There are also no legal provisions that require marketing authorization (registration) for all pharmaceutical products on the market.

In Lesotho, legal provisions exist allowing for appointment of government pharmaceutical inspectors. Legal provisions exist, permitting inspectors to inspect premises where pharmaceutical activities are performed. Such inspections are not required by law but are a pre-requisite for the licensing of private facilities. Where inspections are legal requirements, these are not the same for public and private facilities.

In Lesotho, there are no legal provisions in the Medicines Act that provide for pharmacovigilance activities as part of the MRA mandate. Legal provisions do not exist either requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA. Laws regarding the monitoring of Adverse Drug Reactions (ADR) do not exist in Lesotho. A national pharmacovigilance centre linked to the MRA does not exist (World Health Organization, 2011).