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Licensing And Enforcement

Licensing And Enforcement

OUR

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. 

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.

List of Gazetted Inspectors

Dr Seima Dijeng
Chief Executive Officer
Dr. Ndindoga Mosimane
Regulatory Officer
Ms. Tshegofatso Chilume
Manager Inspection and Licensing
Mr. Patrick Mokula Kgori
Regulatory Officer
Ms. Matshediso Ramotshabi
Regulatory Officer
Ms. Tebogo Mokotedi
Clinical Trials Manager
Mr. Lebogang Koitsiwe
Pharmacovigilance Manager
Ms. Kago Ntsetselele
Human Medicines Manager
Ms. Ethel Sebua
Dossier Assessment Specialist
Mr. Nonofo Thipe
Legal and Corporate Secretary
Mr. Richard Leepo
Manager, Law Enforcement
Mr. Bashi Ntshonono
Enforcement Officer
Mr Amantle Diare
Enforcement Officer
Mr. Thato Brian Makepe
Enforcement Officer
Ms. Boitumelo Matlhare
Enforcement Officer
Ms. Tuduetso Mmolai
Enforcement Officer
Ms. Boago Setlhalefi
Import/Export Officer
Ms. Kebogolo Masedi
Regulatory Officer
Mr. Tsupo Norman Legwere
Regulatory Officer
Mr. Wapapha Nthomiwa
Pharmacovigilance Officer
Dr. Thabang Phetlhe
Dossier Assessment Specialist
Ms. Kagiso Modise
Pharmacovigilance Officer
Mr. Nonofo Thapelo
Pharmacovigilance Officer

Dr Seima Dijeng

Acting CEO

Dr. Ndindoga Mosimane

Regulatory Officer

Ms. Tshegofatso Chilume

Manager Inspection and Licensing

Mr. Patrick Mokula Kgori

Regulatory Officer

Ms. Matshediso Ramotshabi

Regulatory Officer

Ms. Tebogo Mokotedi

Clinical Trials Manager

Mr. Lebogang Koitsiwe

Pharmacovigilance Manager

Ms. Kago Ntsetselele

Human Medicines Manager

Ms. Ethel Sebua

Dossier Assessment Specialist

Mr. Nonofo Thipe

Legal and Corporate Secretary

Mr. Richard Leepo

Manager, Law Enforcement

Mr. Bashi Ntshonono

Enforcement Officer

Mr Amantle Diare

Enforcement Officer

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.

Registered Premise

Manufacturers

Three types of manufacturers are licensed (issued in compliance with the applicable current Good Manufacturing Practices (cGMP).

  1. Human medicines
  2. Veterinary
  3. 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.
BoMRA Background

The Botswana Medicines Regulatory Authority (BoMRA) Was established through the Medicines and Related Substances Act of 2013. The MRSA Authorises BoMRA to perform functions given by the shareholder – The Government of Botswana. The MRSA of 2013 replaced the repealed Drugs and Related Substances Act No.

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Dr. Seima Dijeng

Dr Seima Dijeng is the Chief Executive Officer (CEO) of BoMRA. Before assuming the acting appointment role, he served as the Director of Licensing and Enforcement, overseeing inspections and licensing of premises, laboratory services, import and export control, and enforcement.

A career regulatory professional with over 15 years of experience across both the food and pharmaceutical sectors. He has been part of the BoMRA executive management since 2018.

During his tenure as the Director, he coordinated the development of structures, processes, and guidelines to support regulatory activities and services for the licensing and enforcement department.

He holds a Master of Science in Food, Safety, and Risk Analysis from University College Dublin, the Republic of Ireland, Bachelor of Veterinary Science, from the University of Queensland in Australia.

Dr. Kefentse Motshegwa

Dr. Motshegwa is the Director of Veterinary Services at the Ministry of Agriculture. His illustrious career in veterinary services spans over 23 years in various positions within the veterinary space.

He previously served as Deputy Director – Compliance at the Department of Veterinary Services, Chairperson of the National Residue Committee, and Coordinator of Performance of Veterinary Services Evaluation for the World Organisation for Animal Health founded as OIE.

He brings to the Board a wealth of experience in compliance and regulation in animal health, food safety & veterinary medicines. He is a member of the Botswana Vaccine Institute Board of Directors.

He holds a Master of Science in Biology and Control Parasitic Diseases and Vectors from the University of Liverpool, School of Tropical Medicine, and a Bachelor of Veterinary Medicine from the University College Dublin, Ireland

Dr. Ditiro Duma Coyne

Dr. Coyne is a veterinarian with a career spanning over 15 years in mixed private practice in Gaborone. He has been actively involved in animal welfare and has been the veterinary advisor to the Botswana Society for the Prevention of Cruelty to Animals for several years.

He was the President of the Botswana Veterinary Association for 8 years and has made great strides in advancing Continuous Professional Development for Veterinarians in the country. He brings to the Board vast experience in veterinary education and advocacy as well as Animal Health and Production.

He is currently the World Small Animal Veterinary Association Country Representative for Botswana.

He holds a Bachelor of Veterinary Medicine and Surgery, and a Bachelor of Sciences Veterinary Biology both from Murdoch University, Australia.

Ms. Elizabeth Kelentse

Ms. Kelentse is the Pharmaceutical Care Improvement Specialist at the Botswana-University of Maryland School of Medicine Health Initiative.

She is an enthusiastic and hardworking Pharmacist who brings vast experience to the Board. Her career spans over 12 years from clinical pharmacy to community pharmacy, medicines regulatory experience in the evaluation of clinical trials protocols, and pharmacovigilance: health care management and public health programming.

She has served on the executive committees of the Pharmaceutical Society of Botswana, Botswana Health Professions Council, Young African Leaders Initiative Alumni as well as the National Adverse Events Following Immunisation.

She holds a Bachelor of Science (Pharmacy) University of West Indies St Augustine, Trinidad & Tobago.

Ms. Matshediso Matome

Ms. Matshediso Matome is a Faculty of Health Sciences lecturer at the University of Botswana. She is a seasoned academic who brings to the Board vast experience in the areas of research, health risk management, and delivery of innovative, quality, and cost- effective healthcare solutions for the public and private sectors.

Ms. Matome has previously served in various leadership and senior management positions, including Claims Manager and Head of Managed Care at the Associated Fund Administrators.

She holds a Master’s degree in Pharmacology and Toxicology from, the State University of New York Buffalo, NY, USA, and a Bachelor of Pharmacy, from Albany College of Pharmacy, Albany, USA

Dr Kobedi Segale

Dr. Segale is the Registrar of the Veterinary Surgeons Council. He is a passionate veterinary surgeon with intimate experience in the regulation of the veterinary profession. He has previously served as Deputy Director – Disease Control Division, in the Department of Veterinary Services, responsible for national animal health strategies, programs, and legislation. Dr. Segale brings to the Board a wealth of experience in monitoring and evaluating animal health programs veterinary public health, import and export controls, and animal traceability.

He holds a Master of Science in Tropical Animal Health, from the Institute of Tropical Medicine, Antwerpen, Belgium, and a Bachelor’s degree in Veterinary Medicine from the University College of Dublin, Ireland.

Ms. Mmama Mhlanga – Fichani

Ms. Mhlanga – Fichani is the Vice President, Human Resources and Communications, at Khoemacau Copper Mining. She is a human resources professional with an illustrious career, spanning over15 years in senior management positions. She has held senior leadership positions in diverse industries including, Director of Human Resources at Air Botswana and the Country Head of Human Resources at Standard Chartered Bank Botswana, Head of Human Resources at Be Mobile, Human Resources Manager at African Comprehensive HIV/AIDS Partnership and Human Resource Manager at Non-Bank Financial Institutions Regulatory Authority, respectively.

She brings to the Board vast experience in human resources and communication, organisational effectiveness, employee relations, and change management.

Ms. Mhlanga – Fichani holds a Master’s Degree in Business and Workforce Development from the University of Pennsylvania, USA, a Bachelor of Science in Business Management Human Resources Management, and Marketing Management, from Fairmont College, West Virginia USA, and a Degree of Associate of Science in Business Science- Human Resources Management, September, Calhoun State Community College, Decatur, Alabama, USA.

Mr. Modisa Kebonyemodisa

Mr. Kebonyemodisa is a Partner at Kebonyemodisa Law Office, he is admitted attorney of the High Court of Botswana. Before venturing into private practice, he worked as a Senior Prosecution Counsel at the Directorate of Public Prosecutions.

Mr. Kebonyemodisa is an accomplished legal advisor with over 15 years of experience providing legal counsel to businesses of all sizes. He brings to the Board vast experience in legal practice, corporate law, and extensive knowledge in the legal profession.

He holds a Bachelor of Law degree from, the University of Botswana and Trial Advocacy, Justice Advocacy Training (NITA) (Botswana)

Ms. Tiny Ralefala

Ms. Ralefala is a finance professional with a proven record of leadership, corporate governance, and risk management.

Her impressive professional track record spans over 26 years in finance, audit and accounting in reputable institutions as well as in civil service.

She previously worked as the Chief Finance Officer for Citizen Entrepreneurial Development Agency. Prior to her joining Citizen Entrepreneurial Development Agency she worked as the Finance Manager at the Motor Vehicle Accident Fund.

As a Chartered Financial Accountant, Ms. Ralefala brings to the Board a wealth of experience accustomed to managing projects in finance, audit and risk. She holds a Bachelor of Commerce degree from the University of Botswana. Ms. Ralefala is a fellow member of the Association of Chartered Accountants and the Botswana Institute of Chartered Accountants. She is the current Botswana Institute of Chartered Accountants Practice Review Committee Chairperson.

Dr. Lorato Mangadi-Mokama

 Dr. Lorato Mangadi- Mokama is the  Head of Operations at the Botswana Public Officers Medical Aid Scheme.
She has previously held other  leadership roles within the private healthcare industry, including Chief Operations Officer at the Botswana Medical Aid Society and Managing Director at MRI Botswana Limited. Prior to that, she practiced as a medical doctor in the public health sectors of Australia and Botswana.

Healthcare administrator and funding expert, with her extensive background in the private healthcare industry, she brings to BoMRA a wealth of experience and knowledge in business management and leadership.

She holds a Bachelor of Medicine from the University of Newcastle (Australia) and a Master of Business Administration from the University of Botswana.

She also has various leadership and professional certifications including Executive Leadership Program from Wits Business School and Healthcare Economics from Harvard Business School

Dr. Kegomoditswe Biki Maphane

Dr Kegomoditswe Biki Maphane is the Senior Manager – Safety and Sustainability Development at Debswana Diamond Company, Jwaneng Mine. He is a specialist in Occupational Medicine, Safety & Sustainable Development.

He has held various positions within the Debswana mines, including the Jwaneng Mine Hospital superintendent, and rose to executive leadership.

Dr Maphane provides leadership to the BoMRA Board and oversees the governance and strategic direction of the Authority. He holds a Bachelor of Medical Sciences, and Bachelor of Medicine / Bachelor of Surgery from the University of Melbourne, Australia