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

16. Cancellation of registration

 

(1) If the Authority—
(a) is of the opinion that a holder of a certificate of registration has failed to comply with any condition subject to which any medicine, medical device or IVD was registered;
(b) is of the opinion that any medicine, medical device or IVD does not comply with any prescribed requirement; or
(c) is of the opinion that it is not in the public interest that any medicine, medical devise or IVD shall be available to the public,

the Authority shall cause notice in writing to be given accordingly by the Chief Executive Officer to the holder of the certificate of registration issued in respect of that medicine, medical device or IVD.

[Section 16(1) substituted by section 9 of Notice No. 19, GG 39585, dated 8 January 2016]

 

(2) Any such notice shall specify the grounds on which the Authority’s opinion is based, and shall indicate that the person to whom it is directed may within one month after receipt thereof submit to the Chief Executive Officer any comments he or she may wish to put forward in connection with the matter.

 

(3) If no such comments are so submitted, or if after consideration of any comments so submitted the Authority is of the opinion that the registration of the medicine, medical device or IVD in question should be cancelled, the Authority may cancel the registration thereof.

 

(4) If the person who is the holder of the certificate of registration issued in respect of any medicine, medical device or IVD fails to pay the prescribed annual fee in respect of the retention of the registration of that medicine, medical device or IVD before or on the prescribed date or such later date as the Chief Executive Officer may determine on application by that person, the Chief Executive Officer shall cancel the registration of that medicine, medical device or IVD.

 

[Section 16 substituted by section 12 of Notice No. 434, GG 32148, dated 21 April 2009]