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.
Consumer Protection Act
The Act contains provisions to provide protection of the interests of consumers by means of investigation, prohibition and control of unfair business practices; and to provide for matters incidental thereto.
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.