Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsRegistration of Medicines16. Application for the registration of a medicine |
| (1) | Any person residing in the Republic may make an application for the registration of a medicine on an application form obtainable from the office of the Chief Executive Officer. |
| (2) | The application referred to subregulation (1) must include the particulars of the person with appropriate knowledge of all aspects of the medicine who shall be responsible for communication with the Authority. |
| (3) | The application contemplated in subregulation (1) shall be accompanied by— |
| (a) | a screening form which is obtainable from the Chief Executive Officer which has been completed by the applicant; |
| (b) | a proposed label for use on the medicine; |
| (c) | where applicable, a copy of the manufacturing licence together with the current Good Manufacturing Practice certificate from the regulatory authority of the country where the medicine is manufactured; |
| (d) | in the case of specified Schedule 5, Schedule 6, Schedule 7 and Schedule 8 substances, a certified copy of a permit to manufacture such substances; |
| (e) | all available data on the safety, efficacy and quality of the medicine, as may be determined by the Authority; |
| (f) | proof of the existence of a manufacturing site, which may include a Site Master File; |
| (g) | any other information as may be required by the Authority; and |
| (h) | the applicable application fee. |
| (4) | The information referred to in subregulation (3) shall be submitted in English. |
| (5) | The application Form referred to in subregulation (1) shall contain at least the following information: |
| (a) | particulars of the applicant and the prospective holder of certificate of registration, including— |
| (i) | name; |
| (ii) | business address; |
| (iii) | postal address; |
| (iv) | telephone number; |
| (v) | fax number, if applicable; |
| (vi) | e-mail address, if applicable; and |
| (vii) | contact details of the person referred to in subregulation (2) in the case of a juristic person; and |
| (b) | particulars of a medicine, including— |
| (i) | proposed proprietary name; |
| (ii) | dosage form; |
| (iii) | strength per dosage unit; |
| (iv) | route of administration; |
| (v) | the country where the medicine is manufactured; |
| (vi) | registration status outside the Republic; |
| (vii) | category, class and a statement identifying the discipline if falling under Category D; |
| (viii) | the name of the manufacturer(s); |
| (ix) | the name of any site where any bioequivalence data was generated; and |
| (x) | approved name of each active pharmaceutical ingredient. |
| (6) | A medicine, in respect of which an application for registration is made, must comply with the technical requirements as determined by the Authority. |
| (7) | An application shall be made in respect of each individual dosage form and strength of a medicine. |
| (8) | In the case where a medicine in respect of which an application for registration is made, is or was registered with any regulatory body outside the Republic, the following information in respect of such medicine shall accompany the application: |
| (a) | a copy of the certificate of registration; |
| (b) | professional information relating to the medicine; |
| (c) | conditions of such registration; and |
| (d) | any other information as may be required by Authority. |
| (9) | The provisions of this regulation shall, with the necessary changes, apply to the application for the registration of veterinary medicines. |
| (10) | An application referred to in subregulation (1) shall be accompanied by one sample of such medicine subject to the provisions of regulation 6(2). |