Licensing and Enforcement
The Department of Licensing and Enforcement is mandated to strengthen the Inspection and Licensing of Premises and Import/Export Controls and ensure general enforcement of the MRSA and regulations.
The Department is also responsible for the testing and analysis of samples through the laboratory services function.
The function contributes to BoMRA’s 3rd Strategic Goal of Establishing a Fully Functional Regulatory System by the year 2023.
- Manager Inspections & Licensing
- Inspections & Licensing (10x officers)
- Administration Assistant
- Manager Enforcement
- IMPEX Office (x2 Officers)
- Enforcement Office (x5 Officers)
- Manager Laboratory Services
- Lab Analysts (x10 Officers)
The Role and Functions of each Unit
Inspections and Licensing-IL Unit:
Imports & Exports Control – IMPEX Unit
Inspection of Pharmaceutical Operations
The Inspectorate is mandated by the MRSA to conduct inspections to assess compliance with the minimum requirements for operating a pharmaceutical business according to set standards.
The following inspection types shall be undertaken:
Licensing of Premises
The licensing function is tasked with the role of issuing the following types of licenses.
Three types of manufacturers are licensed (issued in compliance with the applicable current Good Manufacturing Practices (cGMP).
- Human medicines
- Medical devices
Wholesalers: Inspection conducted on facilities for Good Storage and Distribution Practices.
BoMRA Inspectorate performs the following import/export control activities.
Issuance of permits: Issues import, export and transit authorization for both human and veterinary medicines and medical devices.
PoE Verification: To ensure all regulated products that are imported and exported comply with the set standards.