The mandate of the Authority is to protect public health through regulation of human and veterinary medicines, vaccines, other biological products and to regulate many other substances.
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
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having a sound business strategy is essential to success. Little value may be realized if there isn’t disciplined execution and assessment of the risks involved.
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