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National Health Act, 2003 (Act No. 61 of 2003)

Chapter 11 : Regulations

90. Regulations


(1) The Minister, after consultation with the National Health Council or the Office, as the case may be, may make regulations regarding—

[Section 90(1) amended by section 6(a) of Act No. 12 of 2013]

(a) anything which may or must be prescribed in terms of this Act;
(i) the fees to be paid to public health establishments for health services rendered;
(ii) the fees to be paid to the Office for services rendered;

[Section 90(1)(b) substituted by 6(b) of Act No. 12 of 2013]

(c) the norms and standards for—
(i) the national health systems; or
(ii) specified types of protective clothing and the use, cleaning and disposal of such clothing;

[Section 90(1)(c) amended by section 6(b) of Act No. 12 of 2013]

(cA) the performance of the functions of the Board and the Office;

[Section 90(1)(cA) inserted  6(c) of Act No. 12 of 2013]

(d) the development of an essential drugs list and medical and other assistive devices list;
(e) human resource development;
(f) co-operation and interaction between private health care providers and private health establishments on the one hand and public health care providers and public health establishments on the other;
(g) returns, registers, reports, records, documents and forms to be completed and kept by the national department, provincial departments, district health councils, health care providers, private health establishments and public health establishments;
(h) the functions of persons who render voluntary, charitable or similar services in connection with a public health establishment;
(i) the rendering of forensic pathology, forensic medicine and related laboratory services, including the provision of medico-legal mortuaries and medico-legal services;
(k) notifiable medical conditions;
(m) emergency medical services and emergency medical treatment, both within and outside of health establishments;
(n) environmental health, including health nuisances and medical waste;

[Section 90(1)(n) amended by section 6(d) of Act No. 12 of 2013]

(o) the import and export of pathogenic micro-organisms;
(p) health laboratory services, including—
(i) the classification, accreditation and licensing of health laboratories; and
(ii) setting, monitoring and enforcing quality control standards applicable to health laboratories;
(t) the national health information system contemplated in section 74;
(u) the processes and procedures to be implemented by the Director-General in order to obtain prescribed information from stakeholders relating to health financing, the pricing of health services, business practices within or involving health establishments, health agencies, health workers and health care providers, and the formats and extent of publication of various types of information in the public interest and for the purpose of improving access to and the effective and efficient utilisation of health services;
(v) the processes of determination and publication by the Director-General of one or more reference price lists for services rendered, procedures performed and consumable and disposable items utilised by categories of health establishments, health care providers or health workers in the private health sector which may be used—
(i) by a medical scheme as a reference to determine its own benefits; and
(ii) by health establishments, health care providers or health workers in the private health sector as a reference to determine their own fees, but which are not mandatory; and
(w) generally, any other matter which it is necessary or expedient to prescribe in order to implement or administer this Act.


(1A) The Minister may, after consultation with relevant regulatory authorities, prescribe different norms and standards for different types of health establishments.

[Section 90(1A) inserted by section 6(e) of Act No. 12 of 2013]


(2) The Minister, subject to the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), and after consultation with the National Health Research Ethics Council, may make regulations regarding research on human subjects.


(3) The Minister may, in any regulation made under this Act—
(a) designate as authoritative any methodology, procedure, practice or standard that is recognised as authoritative by internationally recognised health bodies within the relevant profession; and
(b) require any person or body to comply with the designated methodology, procedure, or standard.


(a) The Minister must publish all regulations proposed to be made under this Act in the Gazette for comment at least three months before the date contemplated for their commencement.
(b) If the Minister alters the draft regulations, as a result of any comment, he or she need not publish those alterations before making the regulations.
(c) The Minister may, if circumstances necessitate the immediate publication of a regulation, publish that regulation without the consultation contemplated in paragraph (a).