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

2B. Functions of Authority

 

(1) The Authority must, in order to achieve its objects—
(a) ensure the efficient, effective and ethical evaluation or assessment and registration of medicines, medical devices and IVDs that meet defined standards of quality, safety, efficacy and performance, where applicable;
(b) ensure that the process of evaluating or assessing and registering medicines, medical devices and IVDs is transparent, fair, objective and concluded timeously;
(c) ensure the periodic re-evaluation or re-assessment and monitoring of medicines, medical devices and IVDs;
(d) ensure that evidence of existing and new adverse events, interactions, information with regard to post-marketing surveillance and vigilance is being monitored, analysed and acted upon;
(e) ensure that compliance with existing legislation is being promoted and controlled through a process of active inspection and investigation; and
(f) ensure that clinical trial protocols are being assessed according to prescribed ethical and professional criteria and defined standards.

 

(2) The Authority may—
(a) liaise with any other regulatory authority or institution and may, without limiting the generality of this power, require the necessary information from, exchange information with and receive information from any such authority or institution in respect of—
(i) matters of common interest; or
(ii) a specific investigation; and
(b) enter into agreements to co-operate with any regulatory authority in order to achieve the objects of this Act.

 

[Section 2B inserted by section 3 of Act No. 14 of 2015]