Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsSupply of Medicines5. Importation of medicines in terms of section 15C |
| (1) | A medicine referred to in section 15C(b) of the Act may be sold if— |
| (a) | the medicine is being sold outside the Republic with the consent of the holder of the patent of such medicine; |
| (b) | the medicine is imported from a person licensed by a regulatory authority recognised by the Authority; |
| (c) | the person desiring to import such medicine is in possession of a permit issued by the Authority; and |
| (d) | the medicine is registered in terms of the Act, if such a medicine is so declared. |
| (2) | A person desiring to import a medicine referred to in subregulation (1) shall submit to the Authority— |
| (a) | a duly completed application on a form obtainable from the Authority; |
| (b) | a certified copy of his or her identity document or in the case of a juristic person, a certificate of registration as such or other material proof of incorporation or existence as a juristic person in the Republic; |
| (c) | a certified copy of registration in terms of the Pharmacy Act, where applicable; |
| (d) | a certified copy of a licence in respect of premises in terms of— |
| (i) | section 19 of Customs and Excise Act, 1964 (Act No. 91 of 1964); and |
| (ii) | section 22 of the Pharmacy Act; |
| (e) | documentary proof— |
| (i) | that the medicine is under patent in the Republic; |
| (ii) | that the medicine is registered in its country of export by a regulatory authority recognised by the Authority; |
| (iii) | regarding the lowest price at which the medicine is sold in the Republic; |
| (iv) | regarding the price at which the medicine will be sold in the Republic; |
| (v) | that he, she or it can comply with good manufacturing and distribution practices as determined by the Authority; and |
| (f) | an undertaking that he, she or it will ensure the continued safety, efficacy and quality of the medicine. |
| (3) | The Authority— |
| (a) | may approve the application referred to in subregulation (2) with or without conditions; |
| (b) | shall, if the application is approved, issue the applicant with a permit, which shall be valid for a period of two years; and |
| (c) | may cancel the permit if the holder thereof fails to comply with the conditions of the permit or on any other good cause shown. |
| (4) | The permit issued in of subregulation (3) may only be transferred with the approval of the Authority. |
| (5) | A person issued with a permit in terms of subregulation (3) shall apply to the Authority for the registration of the medicine specified in the permit by submitting to the Chief Executive Officer— |
| (a) | a certified copy of that permit; |
| (b) | an application form obtainable from the Authority completed by the applicant; and |
| (c) | the applicable application fee. |
| (6) | The Authority— |
| (a) | must, if satisfied that the application referred to in subregulation (5) complies with the requirements of the Act and these regulations regarding the safety, efficacy and quality of the medicine, and that its registration is in the public interest, approve the application with or without conditions; and |
| (b) | may issue the person referred to in subregulation (5) with a certificate of registration in respect of such medicine under the name approved by the Authority. |
| (7) | A person importing a medicine in terms of this regulation shall in writing inform— |
| (a) | the Authority of any change of facts in relation to the application for a permit issued in terms of subregulation (3) or conditions under which such permit was issued; |
| (b) | the Authority of any amendments to the application for the registration of medicines or the conditions for the registration of such medicine; and |
| (c) | the holder of a certificate of registration in the Republic of the importation of the medicine in terms of this regulation. |
| (8) | A medicine registered in terms of this regulation may only be sold to the State or a person authorised to sell medicines in terms of the Act or any other legislation. |