THE PRINCIPAL ACT 101 OF 1965

1. THE PRINCIPAL ACT 101 OF 1965 The principal Act provides for the: control of medicines and medical devices the establishment of the Medicines Control Council (MCC) appointment of MCC members by the Minister the MCC members part time and only meet every 6 weeks registration of medicines & medical devices by the MCC appointment of the Registrar by the Minister after consultation with the MCC registrar full time in public service registrar provides secretarial services to the MCC

2. THE MEDICINES AND RELATED SUBSTANCES A / BILL The Bill provides for the: • the control of medicines, medical devices as well as foodstuffs and cosmetics which contain scheduled substances • the establishment of the SA Health Products Regulatory Authority • The Authority as a juristic person • The Authority being subject to the PFMA • the registration of products by the Authority • the appointment of the Authority’s CEO by the Minister • the CEO appointing staff of Authority • the Authority reporting and being accountable to the Minister

3. FUNCTIONS OF AUTHORITY • Same as those of the MCC and are provided for throughout the Act and include: • registration of products • cancellation of registration • authorization of sales of unregistered products • Issuing of licenses for manufacturers / wholesalers / distributors of products • Declaration of products as undesirable products

4. CEO AND STAFF OF AUTHORITY • Minister appoints suitably qualified person as CEO • Disqualifications for appointment as CEO • insolvency • mental unfitness • previous conviction • Removal of CEO from office • serious misconduct • incapacity • engaging in activities undermining the integrity of Authority • Terms of CEO’s appointment • appointed for 5 yrs which is renewable once • subject to performance agreement with the Minister • is accountable to and reports to the Minister • entitled to benefits as determined by the Minister in consultation with the Minister for PSA • Responsibilities of the CEO • General administration of the Authority • Carries out functions of Authority • Manages and directs activities of Authority • Appoints and supervises staff of Authority • Compiles business and financial reports and plans as required in terms of PFMA • Structure of Authority • The Minister, after consultation with the Minister for PSA shall determine: • The structure of the Authority • The human resource policy of the Authority which shall include a Code of Conduct for CEO and staff • The CEO and staff become members of Govt Pension Fund • Staff may be seconded from public service to Authority in accordance with the LRA

5. APPEALS AGAINST DECISION OF AUTHORITY • A person aggrieved by decision of Authority shall first seek to have the matter resolved with the CEO if the matter is administrative in nature • Of matter cannot be resolved, an appeal committee comprising 4 persons + chairperson (2 of them nominated by the appellant) shall hear the appeal • The CEO may appoint committees to assist Authority • Appeal committee’s decision may be reviewed by the High Court

6. TRANSITIONAL MEASURES • Products registered at commencement of the Act deemed to be registered • MCC shall cease to exist a day before the coming into operation of the Act • Anything done by MCC deemed to be done by the Authority.