These Regulations provide rules on the registration and access to the market to medicine; licensing requirements for pharmaceutical operations, manufacturers, wholesalers and dispensaries; as well as on record-keeping, import of medicines, and clinical trials, etc.
This Act provides for the establishment of a Medicines Regulatory Authority; for the registration of medicines and medical devices; for the control of medicines and scheduled substances, and for incidental matters.
Medicines and related substances Act
This Act provides for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.
Essential drug list
These guidelines establish an Essential Drug List of Botswana of 2012 and provide the requirements regarding the levels of availability across health care providers.
This document provides for standard treatment guidelines and the essential medicines list.