Act No. 13, 2003
MEDICINES AND RELATED SUBSTANCES
CONTROL ACT, 2003
Transfer of certificate of registration
21. (1) The holder of a certificate of registration may transfer the certificate
with the approval of the Council, to any other person, who qualifies by virtue of section
44(1)(c) to apply for the registration of a medicine.
(2) An application for approval of the transfer of a certificate of registration
must be made to the Registrar on the prescribed form and must be accompanied by the
certificate of registration in question and the prescribed application fee.
(3) The Registrar must, as soon as is practicable after receipt of the application
referred to in subsection (2), submit that application to the Council for consideration.
(4) If the Council grants the application submitted to it in terms of subsection
(3), the Registrar must
(a)
make the necessary entries in the register relating to the person to whom the
certificate of registration is transferred;
(b)
cancel the existing certificate of registration; and
(c)
issue a new certificate of registration on the prescribed form to the person
referred to in paragraph (a) in respect of the relevant medicine.
Cancellation of registration
22.
(1)
If the Council is of the opinion that
(a)
a person has failed to comply with a condition subject to which a particular
medicine has been registered;
(b)
a particular medicine does not comply with a prescribed requirement; or
(c)
it is not in the public interest to make a particular medicine available to the
public,
the Council must cause notice in writing to be given of that fact by the Registrar to the
holder of the certificate of registration issued in respect of that medicine.
(2)
The notice referred to in subsection (1) must
(a)
specify the grounds on which the opinion of the Council is based; and
(b)
indicate that the person to whom the notice is directed may within one month
after the date of that notice submit to the Registrar any comments, which
he or she may wish to make in connection with the matter.
(3)
If
(a)
no comments as contemplated in subsection (2)(b) are received; or
(b)
after consideration of any comments received,
the Council is of the opinion that the registration of the medicine in question should be
cancelled, the Council must direct the Registrar to cancel the registration of that medicine.
(4) If the holder of the certificate of registration issued in respect of a medicine
fails to pay the prescribed fee in respect of the retention of the registration of that medicine