ICT Policy Africa

Act No. 13, 2003

MEDICINES AND RELATED SUBSTANCES
CONTROL ACT, 2003

if that medicine does not contain any component the sale of which is prohibited by this
Act, or any component in respect of which an application has been rejected, and if that
medicine has not been advertised.
Registration of medicines
19. (1) A person, who wishes to have a particular medicine registered, must
submit an application to the Registrar in the prescribed form.
(2)

The application referred to in subsection (1) must be accompanied by ­

(a)

the prescribed particulars;

(b)

the prescribed sample of the medicine, where appropriate; and

(c)

the prescribed application fee.

(3) The Registrar must, as soon as is practicable after the Registrar receives the
application referred to in subsection (1), submit the application, the prescribed particulars
and the prescribed sample, where appropriate ­
(a)	

to the Council; and

(b)	

in the case of a veterinary medicine, also to the veterinary medicines
committee,

for consideration, and inform the applicant in writing that the application has been so
submitted.
(4) If after consideration of an application, and after any investigation or inquiry,
which the Council may consider necessary, the Council is satisfied that ­
(a)	

the medicine in question is suitable for the purpose for which it is intended
and complies with the prescribed requirements; and

(b)

the registration of that medicine is in the public interest,

the Council must approve the registration of that medicine.
(5) If the Council is not satisfied as contemplated in subsection (4), the Registrar
must inform the applicant in writing ­
(a)	

of the reasons for the Council’s dissatisfaction; and

(b)	

that the applicant may within one month after the date of that notification,
furnish the Registrar with any comments on the Council’s reasons, which
the applicant may wish to make.

(6)	

The Council must reject the application concerned ­

(a)	

if comments as contemplated in paragraph (b) of subsection (5) are not
received by the Registrar from the applicant within one month; or

(b)	

if after consideration of any comments received, the Council is still not
satisfied as contemplated in subsection (4).

(7)

If the Council approves of the registration of a medicine, the Registrar must ­