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.
Health professions Act
This Act regulates and controls the practice of medicine, dentistry, pharmacy and allied health professions, and provides for matters connected and associated therewith.
The Statistics Act
The Statistics Act establishes a body corporate to be known as Statistics Botswana; requires that official statistics be produced by means of a process that is guided by the National Statistical System; and provides principles for the production and dissemination of official statistics and for matters incidental thereto.