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.
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.
Emergency Powers Act
This Act empowers the President of Botswana to make emergency regulations whenever an emergency proclamation is in force. It also specifies the matters which may be provided for in emergency regulations; provides the duration of emergency regulations, and provides for the matters incidental thereto or connected therewith.