Republic shall not extend to acts in respect of such medicine which has been put onto the market by the
owner of the medicine, or with his or her consent;
(b)
prescribe the conditions on which any medicine which is identical in composition,
meets the same quality standard and is intended to have the same proprietary name as that of another
medicine already registered in the Republic, but which is imported by a person other than the person
who is the holder of the registration certificate of the medicine already registered and which originates
from any site of manufacture of the original manufacturer as approved by the council in the prescribed
manner, may be imported;
(c)
prescribe the registration procedure for, as well as the use of, the medicine referred to
in paragraph (b).
[S. 15C inserted by s. 10 of Act No. 90 of 1997.]
16. Cancellation of registration.—(1) If the council—
(a)
is of the opinion that any person has failed to comply with any condition subject to
which any medicine has been registered; or
(b)
is of the opinion that any medicine does not comply with any prescribed requirement;
or
(c)
is of the opinion that it is not in the public interest that any medicine shall be available
to the public,
the council shall cause notice in writing to be given accordingly by the registrar to the holder of the
certificate of registration issued in respect of that medicine.
[Sub-s. (1) amended by s. 14 of Act No. 65 of 1974 (English only) and substituted by s. 4 (a) of Act
No. 20 of 1981.]
Wording of Sections
(2) Any such notice shall specify the grounds on which the council’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 registrar
any comments he 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
council is of the opinion that the registration of the medicine in question should be cancelled, the council
may direct the registrar to cancel the registration thereof.
[Sub-s. (3) amended by s. 14 of Act No. 65 of 1974 (English only).]
Wording of Sections
(4) If the person who is the holder of the certificate of registration issued in respect of any medicine fails
to pay the prescribed annual fee in respect of the retention of the registration of that medicine before or
on the prescribed date or such later date as the registrar may with the approval of the council determine
on application by that person, the registrar shall cancel the registration of that medicine.
[Sub-s. (4) added by s. 3 of Act No. 29 of 1968, amended by s. 14 of Act No. 65 of 1974 and substituted
by s. 4 (b) of Act No. 20 of 1981 (English only).]
Wording of Sections
17. Notification of registration or cancellation of registration in Gazette.—The registrar shall give
notice in the Gazette of the registration or cancellation of the registration of any medicine in terms of this
Act, and shall in such notice specify—
(a)
in the case of a registration of any medicine, the name under which such medicine is
registered, the active components of such medicine, the name of the person who applied for the
registration of such medicine, the number allocated to it in terms of section 15 and the conditions (if any)
subject to which it is registered;
(b)
in the case of a cancellation of the registration of any medicine, the name under which
such medicine was registered, the name of the holder of the certificate of registration issued in respect
of such medicine and the number which was allocated to it in terms of section 15.
[S. 17 amended by s. 4 of Act No. 29 of 1968 and substituted by s. 15 of Act No. 65 of 1974. Para. (b)
substituted by s. 5 of Act No. 20 of 1981.]
Wording of Sections
18. Labels and advertisements.—(1) No person shall sell any medicine or Scheduled substance
unless the immediate container or the package in which that medicine or Scheduled substance is sold
bears a label stating the prescribed particulars.
(2) No person shall advertise any medicine or Scheduled substance for sale unless such advertisement
complies with the prescribed requirements.
(3) The label referred to in subsection (1) shall be approved by the council.
[Sub-s. (3) added by s. 11 of Act No. 90 of 1997.]
(4) The council may authorise a deviation from the prescribed format and contents of any label.
[Sub-s. (4) added by s. 11 of Act No. 90 of 1997.]
(5) The Minister may prescribe additional requirements for the labelling of medicines.
[S. 18 substituted by s. 16 of Act No. 65 of 1974 and by s. 7 of Act No. 17 of 1979. Sub-s. (5) added by
s. 11 of Act No. 90 of 1997.]
Wording of Sections