Licensing and Enforcement
The Department of Licensing and Enforcement is mandated with strengthening the Inspection and Licensing of Premises and Import/Export Controls as well as ensuring general enforcement of the MRSA and regulations thereof. It is in this regard that the function contributes to BoMRA’s 3rd Strategic Goal of establishing a Fully Functional Regulatory System by 2023.
The Department is also responsible for the testing and analysis of samples through the laboratory services function.
The Organogram of the department is as follows:
- Manager Inspections & Licensing
- Inspections & Licensing (10x officers)
- Manager Enforcement
- IMPEX Office (x2 Officers)
- Enforcement Office (x3 Officers)
- Manager Laboratory Services
- Lab Analysts (x6 Officers)
Inspections and licensing of premises along with the supply of all regulated products. The scope of this unit covers the following:
Basis of Inspection
Highlights achievements: Inspections conducted: distributor / retails, Pharmacies
Over this past year (2021) the department conducted 272 inspections covering 200 renewals, 55 prelicensing, and 18 spot checks. Of these 180 were human medicines 90 were veterinary medicines premises and 2 were medical devices manufacturers. The department has subsequently licensed 238 premises out of which 134 were Retailers, 24 were distributors, 4 were Institutional pharmacies, 75 were VMP retailers and 1 was a manufacturer. The premises inspected were at a 91% compliance level with set standards.
Compliance level for the inspected premises was 87% emanating from 238 licensed issued out of the inspected 272 premises. Of these inspections 162 human medicines premises were licensed and 18 unlicensed, 75 VMP licensed with 15 unlicensed and 1 MD licensed and 1 not licensed.
The department is embarking on an exercise to attain ISO 17020 certification for the BoMRA inspection body. Over the past year, the department has been working on gap analysis and addressing the gaps to meet the requirement set in the standards. So far the department has addressed up to 70% of the identified gaps and is working on closing the few left.
The ongoing Covid outbreak has led to the introduction of remote inspections/virtual inspections as a way to ensure continuity of business during movement restrictions. Validation of this process is ongoing.
This year saw the inspection of some of the major private hospital pharmacies inspected for licensing as the department shifts to include institutional facilities in its scope of work.
One license was withdrawn through the enforcement unit due to the contravention of MRSA
Expansion to new areas of regulation without matching capacity (cosmetics and MDs) was a hindrance. Training on medical device regulation for staff is ongoing. RO engaged in webinars on medical device regulation to facilitate implementation.
GMP activities still stalling due to competency issues. The GMP capacity gaps are being addressed through MOU with MCAZ virtual inspections participation. Ongoing virtual training on GMP. GMP activities time consuming and need dedicated staff to implement GMP activities.
The ongoing covid cases led to delays in inspections as the unavailability of responsible persons or inspectors led to an inspection backlog, the department had to readjust the annual inspection plan leading to delayed inspections and premises operating with expired licences.