Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)7. Appeal against decision of Council |
| (1) | A person aggrieved by a decision of the Council may, as contemplated in section 24 of the Act, lodge an appeal against the decision, in writing, within 30 days of being notified of the decision of the Council. |
| (2) | Notice of the appeal must be submitted to the Chairperson of the Council, for attention the Registrar, Medicines Control Council, Private Bag X828, Pretoria, 0001. |
| (3) | The notice referred to in subregulation (2) must set out clearly and succinctly the basis for the appeal. |
| (4) | The Registrar must, within 30 days of receipt of a notice of appeal, in the absence of legal representatives, meet with the appellant to try and resolve the matter. |
| (5) | If the matter is not resolved as contemplated in subregulation (4), the appellant may, within 30 days of being notified by the Registrar of the failure to resolve the matter, and upon payment of the prescribed fee, request the Minister to convene an appeal committee. |
| (6) | The appeal committee— |
| (a) | must determine the procedure for its hearings; |
| (b) | may, if it considers it necessary, call for oral evidence or argument or summon any person who— |
| (i) | in its opinion may be able to give information concerning the subject of the appeal; or |
| (ii) | it believes has in his or her possession or under his or her control a document which has a bearing on the subject of the appeal, to appear before it at a time and place specified in the summons, to be asked questions or to produce a document; |
| (c) | must, if it calls for oral evidence or argument— |
| (i) | determine the date, time and place for the appeal and must communicate thee in writing to the appellant and the Council; and |
| (ii) | administer an oath to, or accept an affirmation from, any person called as a witness at the appeal. |
| (7) | A person appearing before the appeal committee may be represented by a legal practitioner. |
| (8) | The appeal committee must consider the appeal and make a decision within a period of 30 days from the date on which it first meets to hear the appeal. |