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Licensing and Enforcement
General
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.Â
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.
Departmental organogram
CEO- CRO
- Director-LE
- 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:
- Responsible for carrying out inspections and licensing of premises along the supply chain of all regulated products.
- Both veterinary and human medicine facilities are regulated through the services of the IL Unit. Inspections are carried out in pharmaceutical manufacturers, wholesalers, retailers, public health institutions and traders of Schedule 4 and complementary medicines.
Imports & Exports Control – IMPEX Unit
- The Imports & Exports Control Unit IMPEX is responsible for establishing and maintaining an effective and efficient import/export control system for BOMRA. This is to ensure compliance with import/export control laws and regulations governing medicines and related substances in Botswana. The unit further provides oversight on the transit of medicines and related substances at ports of entry.
Enforcement Unit
- The Unit conducts investigations and imposes various enforcement sanctions to ensure compliance with the legal requirement of the Medicines and Related Substances Act (2013). Works closely with Botswana police and other law enforcement agencies to regularize compliance with the Act. Enforcement activities include carrying out capacity-building exercises which involve the training of other enforcement partner agencies regularly. Enforcement personnel comprises a dedicated team of Five (5) who conduct compliance inspections around the country. The team also assist with the apprehension and prosecution of both licensed and unlicensed persons dealing in unregistered medicines and/or selling medicines from unlicensed premises.
Laboratory Services
- The Lab Provides testing and analysis of samples to ensure that pharmaceutical products in circulation are of acceptable quality, efficacy, and safety. This is done through the implementation of laboratory quality management systems based on the principles of ISO 17025 and WHO accreditation guidelines.
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:
Spot-inspection
- Random checks are carried out to ensure that licensed premises are under the continuous personal supervision of registered persons in line with the relevant legal requirements. Spot inspections are conducted randomly during the premises operating times. This is to ensure that premises are trading in compliance with specified requirements.
Routine inspection
- The Inspections unit conducts routine inspections for all regulated entities at least once a year. The frequency of inspections can be increased or reduced based on the risk associated with the premises
Investigative inspection
- Investigations may be carried out because of non-compliances identified in the inspection process or using intelligence gathered by BoMRA, other agencies or reported by members of the public. Investigation activities are frequently conducted in conjunction with other law enforcement agencies.
Pre-licensing inspection
- Inspection checks are conducted to assess compliance with the minimum requirements before issuing of license for operating a pharmaceutical business operation.
Licensing of Premises
The licensing function is tasked with the role of issuing the following types of licenses.
Manufacturers
Three types of manufacturers are licensed (issued in compliance with the applicable current Good Manufacturing Practices (cGMP).
- Human medicines
- Veterinary
- Medical devices
Wholesalers: Inspection conducted on facilities for Good Storage and Distribution Practices.
Retailers
- This category of facilities is licensed against Good Dispensing Practices, Good Pharmacy Practices (Pharmacies), Good Veterinary Practices (VMP), and Good Distribution & Good Storage Practices.
Enforcement
- Enforcement activities are performed to ensure industry compliance with the MRSA (2013), the Regulations, Guidelines and associated regulatory requirements. Read more about MRSA (2013)
Import/Export Control
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.
COLLABORATING PARTNERS
BOTSWANA UNIFIED REVENUE SERVICES (BURS)
- BoMRA has an existing memorandum of agreement (MoA) with Botswana Unified Revenue Services (BURS). Under this MoA, BURS facilitates the ports of entry verification.
PORT HEALTH
- Through collaboration with Port Health in the Ministry of Health, the Authority has established a presence at ports of entry to facilitate the ports of entry verification process.
BOTSWANA BUREAU OF STANDARDS (BOBS)
- The Authority is in partnership with BOBS, through a signed memorandum of understanding (MoU) to enhance collaborations and transfer of skills and information between the two organisations.
- This arrangement will allow for BoMRA and BOBS staff to work together on issues relating to standardization as well as technology transfer activities where necessary.
DEPARTMENT OF VETERINARY SERVICES DVS
- The MoU between BOMRA and DVS provides for mutual assistance and collaboration regarding the facilitation of activities relating to the regulation of the supply chain for veterinary medicines.
LOCAL AUTHORITIES
- Inspection of traders of Schedule 4 and complementary medicines is facilitated through a collaborative arrangement between BOMRA Inspectorate and local authorities.
LICENSING COMMITTEE
- This committee is tasked with the duty of administrative oversight to monitor the implementation of inspection and licensing plans and strategies. The functions of the committee are as defined in the Committee’s Terms of References.
