1. INTRODUCTION
1. INTRODUCTION The Board and its four committees reviewed the systems and processes of the organisation timeously. They recognised the role of governance as critical to the efficient and effective functioning of the Regulator. The Board provided assurance to the Authority’s stakeholders that strengthening the existing framework for governance and
Read more2. PORTFOLIO COMMITTEES
2. PORTFOLIO COMMITTEES The following presentations were made by SAHPRA to the Portfolio Committees in Parliament:28 April 2021 - Portfolio Committee on Health: Johnson & Johnson clinical trials, vaccines procurement and progress on the vaccination roll-out programme.5 May 2021 - Portfolio Committee on Health: 2021/22 Annual Performance Plan and budget.25
Read more3. EXECUTIVE AUTHORITY
3. EXECUTIVE AUTHORITY The Regulator submits quarterly reports on its performance and activities to the Executive Authority as mandated by the Medicines and Related Substances Act (1965, as amended) and the PFMA (1999, as amended). In addition, the Executive Authority was briefed on three critical matters:SAHPRA’s progress on the registration
Read more4. THE ACCOUNTING AUTHORITY/BOARD
4. THE ACCOUNTING AUTHORITY/BOARD IntroductionThe Board is the Accounting Authority in terms of the PFMA (1999, as amended) and is appointed for a renewable period of three years by the Minister of Health in terms of the Medicines and Related Substances Act (1965, as amended). The Minister extended the term
Read more5. RISK MANAGEMENT
5. RISK MANAGEMENT SAHPRA has approved the Risk Management Policy and Framework, to embed the risk management activities into the daily operations of the Authority. Periodically, risk assessments are conducted at strategic and operational levels of the Authority to identify and manage risks that may hamper the achievement of its
Read more6. INTERNAL CONTROL UNIT
6. INTERNAL CONTROL UNIT To improve its internal control environment, SAHPRA has intensified the development and review of policies and standard operating procedures within all business units, with the Quality Management Unit driving the process.Management is responsible for the development and maintenance of internal controls to fulfil its responsibility in
Read more7. INTERNAL AUDIT AND AUDIT COMMITTEES
7. INTERNAL AUDIT AND AUDIT COMMITTEES NameQualificationsInternal or ExternalIf Internal, Position in the Public EntityDate AppointedDate ResignedNo. of Meetings AttendedProf. Craig HousehamMBChB MDInternalBoard member17 November 2017N/A5Mr Norman BaloyiMBA BSCMasters in ScienceInternalBoard member17 November 2017N/A6Prof. Shabir BanooBPharm PhDInternalBoard member17 November 2017N/A4Adv. Hasina CassimBPharm LLBInternalBoard member17 November 2017N/A5Ms Lerato MothaeBCompt CTACAInternalBoard member24
Read more8. COMPLIANCE WITH LAWS AND REGULATIONS
8. COMPLIANCE WITH LAWS AND REGULATIONS Adherence and compliance to applicable laws and regulations remain a Board priority as the organisation finds its feet. As a Schedule 3A public entity, SAHPRA is governed by the PFMA (1999, as amended), and National Treasury Regulations published under the PFMA (1999, as amended)
Read more9. FRAUD AND CORRUPTION
9. FRAUD AND CORRUPTION SAHPRA continues to fight fraud and corruption through the implementation of its Fraud Prevention Policy, Strategy and Plan. The Fraud Prevention Strategy and Plan was approved in the 2021/22 financial year and resulted in the development of the fraud risk register together with the facilitation of
Read more10. MINIMISING CONFLICT OF INTEREST
10. MINIMISING CONFLICT OF INTEREST The Board has approved a Management of Conflict of Interest Policy and has procedures in place to manage issues of conflict of interest (perceived, potential or actual) to minimise if not prevent them. Board members, the SAHPRA Executive Committee and senior management are required to
Read more11. CODE OF CONDUCT
11. CODE OF CONDUCT SAHPRA is committed to an exemplary standard of business ethics and transparency in all its dealings with stakeholders. Board members and employees are bound by a code of conduct. Gifts received, if accepted, are declared in line with good corporate governance and the Gift Declaration Policy.
Read more12. HEALTH SAFETY AND ENVIRONMENTAL ISSUES
12. HEALTH SAFETY AND ENVIRONMENTAL ISSUES During this reporting period, SAHPRA continued to implement planned Occupational Health and Safety (OHS) management activities. These activities entailed the effective identification and mitigation of safety, health and environment risks through ensuring ongoing safety, health and environment compliance and training. OHS monthly meetings were
Read more13. COMPANY/BOARD SECRETARY
13. COMPANY/BOARD SECRETARY SAHPRA is a Schedule 3A public entity with an appointed Board Secretary. With effect from March 2022, Ms Letjubana Chokoe was appointed as the acting Board Secretary, following the departure of Advocate Peter Nthotso. She provides advice and supports the Board and is vital to its efficient
Read more14. SOCIAL RESPONSIBILITY
14. SOCIAL RESPONSIBILITY For this financial period, SAHPRA was not involved in any Corporate Social Responsibility initiatives. However, SAHPRA is making in-roads for the next financial year. PrevPreviousHEALTH SAFETY AND ENVIRONMENTAL ISSUES NextAUDIT COMMITTEE REPORTNext
Read more15. AUDIT COMMITTEE REPORT
15. AUDIT COMMITTEE REPORT Risk, Audit and Governance (RAG) Committee ReportIntroductionThe RAG Committee is pleased to present its report for the financial year ended 31 March 2022.The RAG has operated within the approved Committee Charter and complied with all governing legislation in executing its responsibilities in terms of the PFMA
Read more16. BROAD-BASED BLACK ECONOMIC EMPOWERMENT COMPLIANCE PERFORMANCE INFORMATION
BROAD-BASED BLACK ECONOMIC EMPOWERMENT COMPLIANCE PERFORMANCE INFORMATION The following table has been completed in accordance with the compliance to the Broad-Based Black Economic Empowerment (B-BBEE) requirements of the B-BBEE Act (Act No. 53 of 2003) and as determined by the Department of Trade and Industry. Has the Department / Public
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