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.
These Regulations govern the issuance of licenses for the importation, exportation, manufacture, distribution, and retail of drugs, etc.
Botswana
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.