Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsPermits, Licensing and Authorisation26. Permits and authorisation in terms of section 22A |
(1)
| (a) | An application for a permit contemplated in section 22A(9)(a)(i) of the Act by a medical practitioner for the use of a Schedule 7 or 8 substance for the treatment or prevention of a medical condition in a particular patient shall contain at least the following information: |
| (i) | Name and address (both physical and postal) of the medical practitioner; |
| (ii) | identification number of the medical practitioner; |
| (iii) | registration number of the medical practitioner with statutory health council; |
| (iv) | qualifications of the medical practitioner; |
| (v) | contact details of the medical practitioner including the— |
| (aa) | telephone number; and |
| (bb) | facsimile number or email address; |
| (vi) | purpose for which the application is made; |
| (vii) | the name and physical address of the patient, diagnosis, dosage and period of treatment; and |
| (viii) | the place where and the manner in which the scheduled substances shall be stored safely. |
| (b) | The Director-General may issue a permit referred to in subregulation (1) only after consultation with the Authority. |
| (c) | A permit referred to in subregulation (1) may not be issued if the Director-General is of the opinion that the applicant is not capable of keeping or storing the substance in a manner so as to prevent the loss or diversion thereof. |
(2)
| (a) | An application for a permit contemplated in section 22A(9)(a)(i) of the Act by a veterinarian for the use of a Schedule 7 or Schedule 8 substance for the treatment or prevention of a medical condition in a particular animal shall contain at least the following information: |
| (i) | Name and address (both physical and postal) of the veterinarian; |
| (ii) | identification number of the veterinarian; |
| (iii) | registration number of the veterinarian with the statutory council; |
| (iv) | qualifications of the veterinarian; |
| (v) | contact details of the veterinarian including the— |
| (aa) | telephone number; and |
| (bb) | facsimile number or email address; |
| (vi) | purpose for which the application is made; |
| (vii) | the name and address of the owner of the animal, diagnosis, dosage and period of treatment; and |
| (viii) | the place where and the manner in which the scheduled substances shall be stored safely. |
| (b) | The Director -General may issue a permit referred to in paragraph (a) only after consultation with the Authority. |
| (c) | A permit referred to in paragraph (a) may not be issued if the Director -General is of the opinion that the applicant is not capable of keeping or storing the substance in a manner so as to prevent the loss or diversion thereof. |
(3)
| (a) | An application for a permit contemplated in section 22A(9)(a)(i) of the Act by an analyst or researcher desiring to be provided with a Schedule 7 or Schedule 8 substance for the purposes of education, analysis or research, shall contain at least the following information: |
| (i) | Name and address (both physical and postal) of analyst or researcher; |
| (ii) | identification number of analyst or researcher; |
| (iii) | name and address of employer; |
| (iv) | qualifications of the analyst or researcher; |
| (v) | contact details of the analyst of researcher including the: |
| (aa) | telephone number; and |
| (bb) | facsimile number or email address; |
| (vi) | particulars of the intended education, analysis or research project; |
| (vii) | address at which the education, analysis or research will be undertaken; |
| (viii) | estimated duration of project or activity; |
| (ix) | total quantity of scheduled substances to be kept in stock per annum; |
| (x) | source of supply; and |
| (xi) | the place where and the manner in which the scheduled substances shall be stored safely. |
| (b) | The Director-General may issue a permit referred to in paragraph (a) only after consultation with the Authority. |
| (c) | A permit referred to in paragraph (a) may not be issued if the Director-General is of the opinion that the applicant is not capable of keeping or storing the substance in a manner so as to prevent the loss or diversion thereof. |
| (4) | An application for a permit contemplated in section 22A(9)(a)(i) of the Act to manufacture any specified Schedule 5 or Schedule 6 substance shall contain at least the following information: |
| (a) | Name and address (both physical and postal) of the applicant; |
| (b) | name and registration number of the responsible pharmacist; |
| (c) | a certified copy of the manufacturing licence issued by the Authority in terms of section 22C(1)(b); |
| (d) | contact details of the applicant including the— |
| (i) | telephone number; and |
| (ii) | facsimile number or email address; |
| (e) | address at which manufacturing is to be undertaken; and |
| (f) | estimated quantity of specified Schedule 5 or Schedule 6 substance that will be manufactured. |
(5)
| (a) | An application for a permit contemplated in section 22A(9)(a)(ii) of the Act to manufacture, use or supply a Schedule 5 or Schedule 6 substance for other than medicinal purposes shall contain at least the following information— |
| (i) | name and address (both physical and postal) of applicant; |
| (ii) | contact details of the applicant, including the: |
| (aa) | telephone number; and |
| (bb) | facsimile number or email address; |
| (iii) | name and address of contact person; |
| (iv) | identification number of contact person; |
| (v) | qualifications of the contact person; |
| (vi) | contact details of the contact person, including the— |
| (aa) | telephone number; and |
| (bb) | facsimile number or email address; and |
| (vii) | purpose for which the application is made. |
| (b) | The Director -General may issue a permit referred to in paragraph (a) only after consultation with the Authority. |
(6)
| (a) | An application for a permit contemplated in section 22A(7)(a) of the Act shall contain at least the following information: |
| (i) | Name and address (both physical and postal) of applicant; |
| (ii) | contact details of the applicant, including the— |
| (aa) | telephone number; and |
| (bb) | facsimile number or email address; |
| (iii) | name and address of contact person; |
| (iv) | identification number of contact person; |
| (v) | qualifications of the contact person; |
| (vi) | contact details of the contact person, including the— |
| (aa) | telephone number; and |
| (bb) | facsimile number or email address; |
| (vii) | source of supply; and |
| (viii) | the place where and the manner in which the scheduled substances shall be stored safely. |
| (b) | A permit referred to in paragraph (a) may not be issued if the Director-General is of the opinion that the applicant is not capable of keeping or storing the substance in a manner so as to prevent the loss or diversion thereof. |
(7)
| (a) | An application for a permit contemplated in section 22A(15) of the Act shall contain at least the following information: |
| (i) | Name and address (both physical and postal) of applicant; |
| (ii) | identification number of applicant; |
| (iii) | name and address of employer; |
| (iv) | qualifications of the applicant; |
| (v) | proof of registration with the relevant statutory health council, if applicable (vi) contact details of the applicant including the— |
| (aa) | telephone number; and |
| (bb) | facsimile number or email address; |
| (vii) | source of supply; and |
| (viii) | the place where and the manner in which the scheduled substances shall be stored safely. |
| (b) | A permit referred to in paragraph (a) may not be issued if the Director-General is of the opinion that the applicant is not capable of keeping or storing the substance in a manner so as to prevent the loss or diversion thereof. |
| (c) | A permit referred to in this subregulation may be withdrawn, revoked or suspended by the Director-General if the person issued with such a permit fails to comply with the conditions or requirements for issuing the permit. |
| (8) | A application for an authorisation contemplated in section 22A(10) of the Act shall contain at least the following information: |
| (a) | Name and address (both physical and postal) of medical practitioner; |
| (b) | identification number of the medical practitioner; |
| (c) | registration number of the medical practitioner with statutory health council; |
| (d) | qualifications of the medical practitioner; |
| (e) | contact details of the medical practitioner including the— |
| (i) | telephone number; and |
| (ii) | facsimile number or email address; |
| (f) | purpose for which the application is made; and |
| (g) | the place where and the manner in which the scheduled substances shall be stored safely. |
| (9) | Any permit holder or person referred to in this regulation may be subject to regular inspections of the premises or practice in terms of section 28 of the Act. |