| (1) | Subject to the provision of information, requirements and conditions as determined by the Authority, a person desiring to sell an unregistered medicine subject to registration in terms of section 14 of the Act, for purposes other than a clinical trial, shall apply to the Authority, on an application form obtainable from the office of the Chief Executive Officer, for authorisation in terms of section 21 of the Act to sell such a medicine. |
| (2) | An application referred to in subregulation (1) must be accompanied by the prescribed fee and must contain at least the following information— |
| (a) | duly completed application form; |
| (b) | product brochure containing relevant chemical, pharmaceutical, pre-clinical pharmacological and toxicological data and where applicable, human or animal pharmacological and clinical data with the medicine concerned; |
| (c) | witnessed informed consent document, where applicable; |
| (d) | details of registration or pending registration of the medicine with any other regulatory authority, if available; |
| (e) | evidence of compliance of the manufacturer of the medicine with Good Manufacturing Practice standards as determined by the Authority; |
| (f) | reasons why a South African registered medicine cannot be used; and |
| (g) | any other information as may be required by the Authority. |
| (3) | The person under whose supervision the unregistered medicine or substance is prescribed shall submit to the Authority— |
| (a) | any adverse event report; |
| (b) | progress reports after every six months from the date following commencement of the use of the unregistered medicine; and |
| (c) | progress report 30 days after the completion or termination of the use of the medicine. |
(4) The Authority may—
| (a) | impose any additional conditions; |
| (b) | request additional information; |
| (c) | inspect the site where the unregistered medicine is manufactured, stored or administered; or |
| (d) | withdraw the authorisation to treat the patient or animal, |
if the Authority is of the opinion that the or animal is compromised, that the scientific reasons for administering the unregistered medicine have changed or for any other reason as determined by the Authority.
| (5) | A medicine referred to in subregulation (1) shall be properly labelled and the package shall sufficiently identify the information as per the provisions of regulation 12(5)(c). |
