OUR
Board Committees
The Board has appointed three (3) committees to assist in executing the Authority’s mandate. The Committees established by the Board operate on the basis of their terms of reference which set out their responsibilities.
The Committees include the Technical and Non-Technical Committees. Over the period under review the Authority established the Governance and Nominations Committee to strengthen corporate governance and its implementation within the Authority. The Authority is further in the process of establishing the Licensing Committee for oversight over the Licensing and Inspections Function. The Committees of the Board are as set out below:
Registration Committee
- Ensuring that registered medicines meet the provisions of the MRSA, Regulations, Policies, Standards, the set conditions and requirements for registration.
- Considering and advising the Authority on the registration of medicines
- Recommending rejection of applications, suspension or removal from the Register of any medicines per the Act, Regulations, Policies and Standards
- Reviewing of the registration fees and recommendation to the Board for endorsement and approval by the Minister.
Pharmacovigilance Advisory Committee
- Guiding the Authority on pharmacovigilance functions and conduct of clinical trials.
- Making decisions on risk-benefit assessments of the medicines registered in Botswana based on the quality, safety and efficacy of the medicines.
- Making recommendations to the Registration Committee on safety and efficacy pre and post-marketing authorization.
- Making recommendations on risk minimisation measures to the Marketing Authorization holders and health programs.
- Reviewing promotional and advertising materials for its content and presentation.
- Reviewing promotional and advertising materials for its content and presentation.
Licensing Committee
- Reviewing and recommending policies, procedures, and standards for licensing purposes.
- Approving guidelines, procedures, and inspection programmes for both local and external inspections.
- Approving criteria for enforcement actions to be adopted by the Authority for matters that need not be prosecuted through the courts.
- Reviewing of the licensing fees proposed by the Authority for recommendation to the board.
- Reviewing decisions by the Licensing and Inspections Department where there are grievances and complaints by clients, where they are aggrieved by decisions made by the Authority in the execution of its licensing functions.
- Accounting practices, financial controls, and reporting systems of the Authority.
- Budgeting, budgetary control systems, and auditing processes of the Authority.
- Authority’s enterprise-wide risk management, risk management, and risk avoidance measures.
- Economy, efficiency, and effectiveness of the Authority’s Information Technology.
- Reviewing and recommending the Human Resources Strategy to the Board.
- Reviewing and reporting annually to the Board on the Authority’s succession planning for critical positions.
- Reviewing and recommending for approval, the CEO’s recommendations for appointment of Executive Management.
- Reviewing and recommending, the organizational structure changes.
- Recommending the CEO’s performance objectives for approval by the Board.
- Corporate governance practices, principles, guidelines, and related policies of the Board.
- Nominations of candidates for appointment to the Board and Committees.
- Composition, development, and evaluation of the Board and Committees.
- Matters relating to integrity and ethics.
- Shareholder agreement and other shareholder requirements.
- The Authority’s corporate social responsibility program.
- Technical advisory on governance matters emanating from other Committees.
- Ensuring that registered medical products meet the provisions of the MRSA, Regulations, Guidelines, Policies, Standards, the set conditions, and requirements for registration.
- Considering and advising the Authority on the registration of medicines that meet the set standards.
- Rejection of applications, suspension, or removal from the Register of any medicines in accordance with the Act, Regulations, Policies, and Standards.
- Review of the registration fees and recommendation to the Board for endorsement and approval by the Minister.
- Guiding the Authority on pharmacovigilance functions and conduct of clinical trials.
- Review and approval of clinical trial applications and protocols
- Making decisions on risk-benefit assessments of the medicines registered in Botswana based on the quality, safety, and efficacy of the medicines.
- Making recommendations to the Registration Committee on safety and efficacy pre and post-marketing authorization.
- Making recommendations on risk minimisation measures to the Marketing Authorization holders and health programs.
- Reviewing promotional and advertising materials for its content and presentation.
- Reviewing and recommending policies, procedures, and standards for licensing purposes.
- Approving guidelines, procedures, and inspection programs for both local and external inspections.
- Approving criteria for enforcement actions to be adopted by the Authority for matters that need not be prosecuted through the courts.
- Reviewing of the licensing fees for recommendation to the Board.
- Reviewing decisions by the Licensing and Enforcement Department.
