Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsPermits, Licensing and Authorisation31. Obtaining pain control medicines by registered midwives |
| (1) | Any person registered in the category, midwife in terms of the Nursing Act, 2005 (Act No. 33 of 2005), providing intra-partum care in accordance with the relevant scope of practice who wishes to purchase, acquire or keep for administration to patients Schedule 5 or Schedule 6 medicines for intra-partum care in accordance with the latest version of the Standard Treatment Guidelines/Essential Medicines List as approved by the National Essential Medicines List Committee shall apply in writing to the Director-General for a permit. |
| (2) | An application referred to in subregulation (1) shall contain at least the following information: |
| (a) | The name of the applicant, together with proof of current registration with the South African Nursing Council; |
| (b) | the physical address of the premises where in or from which the midwifery services are rendered; |
| (c) | the nature of the midwifery services to be offered; |
| (d) | a list of conditions, including the relevant diagnostic codes that will be managed and for which access to Schedule 5 or Schedule 6 medicines is required per diagnostic code; and |
| (e) | the name and strength of every Schedule 5 or Schedule 6 medicine required. |
| (3) | The Director-General may, upon receipt of such application and after making such inquiries as he or she may deem necessary, issue a permit authorising the applicant to purchase, acquire, keep or administer the requested Schedule 5 or Schedule 6 medicines. |
| (4) | The permit shall be issued in a form as determined by the Director-General. |
| (5) | A permit referred to in subregulation (3) shall be issued subject to the following conditions: |
| (a) | The holder of a permit issued in terms of subregulation (4) shall keep a register of medicines kept in a form as determined by the Authority, in which shall be entered at least the following particulars: |
| (i) | Schedule number; |
| (ii) | name of medicine; and |
| (iii) | strength; |
| (b) | the pharmacist supplying the Schedule 5 or Schedule 6 medicines may not supply a quantity more than that required for 30 days and shall enter the following particulars in a register kept by the midwife: |
| (i) | Date of supply; |
| (ii) | number of permit; |
| (iii) | quantity of medicine supplied; |
| (iv) | name and address of pharmacy; and |
| (v) | the pharmacist's signature; |
| (c) | the midwife shall sign in the presence of a pharmacist for receipt of the Schedule 5 or Schedule 6 medicines; and |
| (d) | the midwife shall enter the following particulars in the register after administration of the Schedule 5 or Schedule 6 medicines: |
| (i) | Date and time of administration; |
| (ii) | name and address of patient; |
| (iii) | quantity administered; |
| (iv) | full signature; |
| (v) | qualifications; |
| (vi) | reason for administration; and |
| (vii) | the balance on hand. |
| (6) | The holder of a permit shall be personally responsible for keeping all medicines purchased or acquired in terms of a permit in safe-keeping. |
| (7) | The holder of a permit shall at all times, at the request of any person duly authorised by the Director-General for purposes of inspection, produce the said permit, register and quantity of Schedule 5 or Schedule 6 medicines in his or her possession. |
| (8) | The Director -General may at any time, by notice to the applicant cancel or withdraw the permit. |
| (9) | On receipt of notification of cancellation or withdrawal, the holder of the permit shall return the permit and the register to the Director-General together with proof that any Schedule 5 or Schedule 6 medicines still in their possession has been handed over to a pharmacist for destruction in accordance with regulation 44. |
| (10) | The Director-General shall keep a register of all permits issued to midwives. |
| (11) | A permit issued in terms of this regulation shall be valid for a period of two years and may be renewed. |
| (12) | A permit shall contain at least the following information: |
| (a) | Permit number; |
| (b) | the name, qualifications and official designation of the authorised official who issued such a permit, in an instance where the Director -General has delegated the power to issue such a permit; |
| (c) | the name, and address of the midwife; |
| (d) | the conditions that may be treated; and |
| (e) | the Schedule 5 or Schedule 6 medicines that may be purchased, and their strength, and dosage form. |