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.
Constitution
The Constitution of Botswana was first adopted in 1966 and reviewed in 2006. It consists of 127 articles that are grouped into 9 chapters. The articles of the Constitution address a large number of issues such as the protection of fundamental rights and freedoms, citizenship rights, the fundamental principles of the state and institutional arrangements.