Act No. 13, 2003 MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 2003 (a) register that medicine; and (b) in the prescribed form, issue to the applicant a certificate of registration in respect of that medicine. (8) Every medicine must be registered under a name approved by the Council. (9) The Registrar must allocate a registration number to every medicine registered under this Act. (10) The registration number referred to in subsection (9) must be recorded in the relevant register and must be stated in the certificate of registration issued in respect of that medicine. (11) The Council may determine the conditions of registration of a medicine under this Act. (12) The Registrar must, as soon as is practicable after the date of expiry of the appropriate period referred to in section 18(4), publish in the Gazette the prescribed particulars in respect of all applications for registration received by him or her prior to that date. (13) The Registrar must give notice in the Gazette of the rejection of an application under this section in respect of a medicine referred to in section 18(4) ­ (a) if no appeal is lodged against the rejection within the period referred to in section 34, as soon as is practicable after that period; or (b) if any appeal lodged is dismissed, as soon as is practicable after the decision dismissing the appeal has been given. Amendment of entries in register 20. (1) The Registrar, on application by the holder of a certificate of registration issued in respect of a medicine, and with the approval of the Council, may amend the entry in a register with respect to that medicine. (2) An application for the amendment of an entry in a register must be made to the Registrar in the prescribed form and must be accompanied by the prescribed application fee. (3) As soon as is practicable after receipt of an application referred to in subsection (2), the Registrar must submit the application to the Council, and in the case of an application relating to a veterinary medicine, also to the veterinary medicines committee, for consideration. (4) If the Council grants its approval in respect of an application submitted to it in terms of subsection (3), the Registrar must ­ (a) make the required amendments in the relevant register; and (b) if the name of the applicant changes, issue a new certificate of registration on the prescribed form to the applicant in respect of the medicine after receiving the existing certificate of registration in respect of that medicine for cancellation.

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