Act No. 13, 2003
MEDICINES AND RELATED SUBSTANCES
CONTROL ACT, 2003
(a)
register that medicine; and
(b)
in the prescribed form, issue to the applicant a certificate of registration in
respect of that medicine.
(8)
Every medicine must be registered under a name approved by the Council.
(9) The Registrar must allocate a registration number to every medicine
registered under this Act.
(10) The registration number referred to in subsection (9) must be recorded in
the relevant register and must be stated in the certificate of registration issued in respect
of that medicine.
(11) The Council may determine the conditions of registration of a medicine
under this Act.
(12) The Registrar must, as soon as is practicable after the date of expiry of the
appropriate period referred to in section 18(4), publish in the Gazette the prescribed
particulars in respect of all applications for registration received by him or her prior to
that date.
(13) The Registrar must give notice in the Gazette of the rejection of an application
under this section in respect of a medicine referred to in section 18(4)
(a)
if no appeal is lodged against the rejection within the period referred to in
section 34, as soon as is practicable after that period; or
(b)
if any appeal lodged is dismissed, as soon as is practicable after the decision
dismissing the appeal has been given.
Amendment of entries in register
20. (1) The Registrar, on application by the holder of a certificate of
registration issued in respect of a medicine, and with the approval of the Council, may
amend the entry in a register with respect to that medicine.
(2) An application for the amendment of an entry in a register must be made to
the Registrar in the prescribed form and must be accompanied by the prescribed application
fee.
(3) As soon as is practicable after receipt of an application referred to in
subsection (2), the Registrar must submit the application to the Council, and in the case
of an application relating to a veterinary medicine, also to the veterinary medicines
committee, for consideration.
(4) If the Council grants its approval in respect of an application submitted to it
in terms of subsection (3), the Registrar must
(a)
make the required amendments in the relevant register; and
(b)
if the name of the applicant changes, issue a new certificate of registration
on the prescribed form to the applicant in respect of the medicine after
receiving the existing certificate of registration in respect of that medicine
for cancellation.