Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsRegistration of Medicines20. Application for amendment to the register for medicines |
| (1) | An application for the amendment of an entry in the register in terms of section 15A of the Act shall be accompanied by the relevant fee and must contain the following particulars— |
| (a) | the registration number of the medicine; |
| (b) | the name of the holder of the certificate of registration; |
| (c) | business address of the holder of the certificate of registration; |
| (d) | declaration by the holder of the certificate of registration that the information furnished is complete and accurate; |
| (e) | the details of the amendment applied for; and |
| (f) | any other information as may be required by the Authority. |
| (2) | Where a new certificate is issued in terms of section 15A(3) of the Act— |
| (a) | the original certificate of registration must be returned to the Authority; or |
| (b) | if the original certificate of registration is lost, an affidavit must be submitted to the Authority confirming that the certificate of registration is lost. |