Act No. 13, 2003

MEDICINES AND RELATED SUBSTANCES
CONTROL ACT, 2003

before or on the prescribed date or such later date as the Registrar, with the approval of
the Council, may determine on application by that person, the Registrar must cancel the
registration of that medicine.
Notification of registration, or cancellation of registration, in the Gazette
23. The Registrar must give notice in the Gazette of the registration, or
cancellation of registration, of a medicine in terms of this Act, and must in such notice
specify ­
(a)	

in the case of a registration of a medicine ­
(i)	

the name under which that medicine is registered;

(ii)	

the active components of that medicine;

(iii)	 the name of the applicant;
(iv)	 the name of the manufacturer;
(v)	

the registration number allocated to that medicine in terms of section
19(9); and

(vi)	 the conditions, if any, subject to which that medicine is registered;
(b)	

in the case of a cancellation of registration of a medicine ­
(i)	

the name under which that medicine was registered;

(ii)	

the name of the holder of the certificate of registration issued in respect
of that medicine; and

(iii)	 the number which was allocated to that medicine in terms of section
19(9).
Labels and advertisements
24.	

(1)

A person may not ­

(a)	

sell a medicine or a scheduled substance, unless the immediate container
and the package, if any, in which that medicine or scheduled substance is
sold, bear a label stating the prescribed particulars; or

(b)	

advertise a medicine or a scheduled substance for sale, unless the
advertisement complies with the prescribed requirements.

(2) The Council may authorise a deviation from the prescribed label format if,
in its opinion, the circumstances of a particular case warrant a deviation.
Prohibition on sale of medicines, which do not comply with prescribed requirements,
and furnishing of information regarding medicines to the Council
25. (1) A person may not sell a medicine, which has been registered in terms
of this Act or in respect of which the Council has authorised the sale as contemplated in
section 27, unless that medicine complies with the prescribed requirements.
(2) The Council may, by notice in writing, require a person, who manufactures,
sells, administers or prescribes a medicine, or on whose direction a medicine is

Select target paragraph3