Drug and Food Control Authority Act, 2012 (Act No. 37).

This Act, comprising 77 Articles divided into XIII Chapters, aims to establish an independent Drug and Food Control Authority in South Sudan and to provide an appropriate and effective independent regulatory mechanism to control and regulate the manufacture, supply, promotion, marketing, advertising, distribution and use of drugs, poisons, chemicals, cosmetics, medical devices and food for human or animal use. The Authority shall establish its Board which shall be entrusted with supervision of the activities and affairs of the Authority, in particular (i) advising the Government on control and regulation of Regulated Products; (ii) regulating and monitoring the use, manufacture, import, export, distribution, and sale of Regulated Products for human or animal use; (iii) enforcing standards of quality, safety, and efficacy; (iv) regulating and inspecting personnel, premises, and practices involved in product-related activities; (v) publishing, applying, and enforcing standards of professional conduct and ethics related to these products, while also regulating misuse and abuse. The Authority shall also establish a Secretariat responsible for its daily management and operations.
Chapter VI covers product registration, marketing, and authorization. Manufacturers and importers must inform the Board, and products are provisionally registered until authorized by the Board. Safety and quality are considered, and unlisted products require authorization. No unlisted product can be imported, manufactured, exported, or sold without Board permission or a marketing authorization license. Chapter VII outlines premises licenses, including manufacturing, importing, retail pharmacies, and drug stores. The Board retains supervisory authority, and licenses are not transferable. The Act also mentions the process for applying, amending, and renewing licenses, as well as the fees associated with them. Chapter IX addresses the control of import, export, and transportation of regulated products. It stipulates that (i) no person can import or transport such products into South Sudan for commercial or public use without a license from the Authority, specifying the authorized product range and duration; (ii) similar requirements apply to the export of regulated products; (iii) a record of imports or exports must be maintained; (iv) licenses for restricted medicines are limited to medical, dental, or veterinary use, and a verification certificate is issued for each consignment by the license holder. Chapter X focuses on quality control through the South Sudan Pharmaceutical Quality Control Laboratory, responsible for conducting tests, analyses, and research to ensure the quality, safety, and well-being of the public regarding regulated products. Regulated products that fail quality and safety standards are denied entry or removed from inventory and destroyed, while expired, damaged, or unsuitable products are disposed of following environmentally friendly practices. Chapter XI covers product naming, labeling, and drug scheduling, and the Board determines scheduling criteria. Finally, restricted medicines can only be handled by registered professionals, following prescriptions and proper record-keeping.