1. PUBLIC ENTITY’S GENERAL INFORMATION

PUBLIC ENTITY’S GENERAL INFORMATION Registered Name: South African Health Products Regulatory Authority (SAHPRA) Registration Number (If applicable): Not applicable Physical Address: Building A Loftus Park 402 Kirkness Street Arcadia Pretoria 0083 Postal Address: Private Bag X828 Pretoria 0001 Telephone Number/s: (012) 501 0300 Email Address: enquiries@sahpra.org.za Website Address: www.sahpra.org.za External Auditors: Auditor-General of South

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2. LIST OF ABBREVIATIONS/ACRONYMS

LIST OF ABBREVIATIONS/ACRONYMS ABBREVIATIONEXPLANATIONAEFIAdverse Event Following ImmunisationAESIAdverse Events of Special InterestAFSAnnual Financial StatementsAGSAAuditor-General of South AfricaAMRHAfrican Medicines Regulatory HarmonisationAUAfrican UnionAUDAAfrican Union Development AgencyAVAREFAfrican Vaccine Regulatory ForumB-BBEEBroad-Based Black Economic EmpowermentBMGFBill and Melinda Gates FoundationCDCCentres for Disease Control and PreventionCHAIClinton Health Access InitiativeCOVID-19Coronavirus DiseaseCPDCorporation for Public DepositsCSIRCouncil for Scientific and Industrial ResearchDPSADepartment

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3. FOREWORD BY THE CHAIRPERSON

FOREWORD BY THE CHAIRPERSON National regulatory authorities ensure the legal and regulatory compliance of the drug development process including clinical development, licensing, registration, manufacturing, marketing, labelling and safety monitoring of health products. This means that the pharmaceutical industry is of necessity one of the most highly regulated industries worldwide. Whenever

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4. CHIEF EXECUTIVE OFFICER’S

CHIEF EXECUTIVE OFFICER’S OVERVIEW Leading regulations through excellence and evidence-based decision-making‘Chaos’ and ‘disruption’ are the best words that encapsulate how COVID-19 impacted the world, our country and SAHPRA.In spite of concerted efforts to fight the COVID-19 pandemic, it is still a threat. However, thanks to our efforts and those of

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5. STATEMENT OF RESPONSIBILITY AND CONFIRMATION OF THE ACCURACY FOR THE ANNUAL REPORT

STATEMENT OF RESPONSIBILITY AND CONFIRMATION OF THE ACCURACY FOR THE ANNUAL REPORT To the best of my knowledge and belief, I confirm the following:All information and amounts disclosed in the annual report is consistent with the Annual Financial Statements (AFS) audited by the Auditor-General of South Africa (AGSA).The annual report

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6. STRATEGIC OVERVIEW

6. STRATEGIC OVERVIEW PrevPreviousSTATEMENT OF RESPONSIBILITY AND CONFIRMATION OF THE ACCURACY FOR THE ANNUAL REPORT NextLEGISLATIVE AND OTHER MANDATESNext

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7. LEGISLATIVE AND OTHER MANDATES

7. LEGISLATIVE AND OTHER MANDATES 7.1 Constitutional MandateThe Constitution of the Republic of South Africa (1996), places an obligation on the state to progressively realise socio-economic rights, including access to healthcare. Section 27 of Chapter 2 of the Bill of Rights of the Constitution (1996) states the following with regard

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7.1 Constitutional Mandate

7.1 Constitutional Mandate The Constitution of the Republic of South Africa (1996), places an obligation on the state to progressively realise socio-economic rights, including access to healthcare. Section 27 of Chapter 2 of the Bill of Rights of the Constitution (1996) states the following with regard to healthcare, food, water,

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7.2 Legislative Mandate

7.2 Legislative Mandate SAHPRA’s objective is to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, in vitro diagnostics and further matters related to the public interest.Since its establishment in February 2018, as a schedule 3A entity of the

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7.3 Policy Mandate

7.3 Policy Mandate The court ruling on the recreational use of cannabis has spurred considerable public interest and debate in relation to the concomitant implications for medicinal applications of cannabis. In addition, commercial interest is tied to a significant potential economic gain based on the legalisation and the subsequent industrialisation

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8. ORGANISATIONAL STRUCTURE

8. ORGANISATIONAL STRUCTURE PrevPreviousPolicy Mandate NextMEMBERS OF THE BOARDNext

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9 MEMBERS OF THE BOARD

MEMBERS OF THE BOARD PrevPreviousORGANISATIONAL STRUCTURE NextEXECUTIVE MANAGEMENTNext

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10. EXECUTIVE MANAGEMENT

EXECUTIVE MANAGEMENTS PrevPreviousMEMBERS OF THE BOARD NextAUDITOR’S REPORT: PREDETERMINED OBJECTIVESNext

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