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 Authoritys 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 CEOs 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

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 committees 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.