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 are the guidelines for the registration, renewal, change in characteristics and extension in range of both imported and locally manufactured registered pharmaceutical products.
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.
Clinical Trials Act
This Act regulates the conduct of clinical trials for medicinal products in Mauritius.
Dangerous Drug Act
This Act provides for the regulation, control and classification of dangerous drugs.
This Act regulates the practice of pharmacy in the country, establishes guidelines for the licensing, operation, and conduct of pharmacies, as well as regulates the sale and manufacture of pharmaceutical products.