Rwanda Food and Drugs Authority hereafter designated as the “Authority”, was established by the law Nº 003/2018 of 09/02/2018 determining its mission, organization and functioning. The mandate of the Authority is to protect public health through regulation of human and veterinary medicines, vaccines and other biological products, processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco and tobacco products.

Product Regulatory Information Management System (PRIMS) automates all the functionalities of the RwandaFDA. This have increased efficiency and improved service delivery time.

PRIMS has the following modules

Product Application

• New Market Authorization License (MAL)
• Retention of Market Authorization License
• Variation of Martlet Authorization License

Import Export Application

• Import Export License
• Import Export Permit

Premise Application

• New Operating License
• Renewal of Operating License

Post Market Surveillance (PMS) and Pharmaco vigilance (PV) Module

• Medical Device Adverse Event Reporting
• Suspected Adverse Drug Reaction Patient Reporting
• Suspected Poor Quality Product Reporting
• Adverse Drug Reaction/Event Following Immunization Reporting

GMP Application

• New GMP Certificate Application
• Renewal of GMP Certificates

Administration Module

• User Managements
• System Audit Reports
• Organization Setups

Finance Module

• Payments setups
• Payments and Invoices Managements

Reports and Dashboard Modules

• Modules summary reports and dashboards
• Dynamic Reports