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Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Regulations

General Regulations

Permits, Licensing and Authorisation

31. 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.

 

 


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