The Essential Medicines and Health Supplies List for Uganda (EMHSLU) 2023 reflects the policy of the Ministry of Health, for the appropriate procurement of safe and efficacious essential medicines, health and laboratory supplies in public institutions.
These guidelines prescribe data, which is required to be submitted to the National Drug Authority to demonstrate the safety, efficacy and quality of vaccines being applied for market authorization. The guidelines also describe the format (CTD) in which dossiers should be presented in support of the application.
The objective of the law is to establish an institutional framework for regulating the pharmaceutical sector to ensure market approval and use of pharmaceutical products that are accessible, safe, efficient, and of appropriate quality (art.2). It notably establishes the Authority for pharmaceutical regulation (Autorité Ivoirienne de Regulation Pharmaceutique - AIRP) and addresses its mandates (chapter 1).
These Regulations govern the issuance of licenses for the importation, exportation, manufacture, distribution, and retail of drugs, etc.
This Act establishes a national drug policy and a national drug authority to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory health care and safeguarding the appropriate use of drugs.