(c) Any such resolution shall be published in the Gazette by the registrar and shall come into operation
on the date on which it is so published.
(3) In the case of a medicine which was available for sale in the Republic immediately prior to the date
of publication in the Gazette of the resolution by virtue of which it is subject to registration in terms of this
Act, the provisions of subsection (1) shall come into operation—
(a)
if no application for the registration of such medicine is made within the period of six
months immediately succeeding that date, on the expiration of that period; or
(b)
if application for the registration of such medicine is made within the said period, on
the date one month after the date on which a notice in respect of such medicine is published in the
Gazette in terms of section 15 (10) or section 17 (a).
[Sub-s. (3) amended by s. 7 (b) of Act No. 94 of 1991.]
Wording of Sections
(4) The provisions of subsection (1) shall not apply in respect of the sale of any medicine—
(a)
compounded in the course of carrying on his or her professional activities by a
pharmacist, veterinarian or person who is the holder of a licence contemplated in section 22C (1) (a), for
a particular patient in a quantity not greater than the quantity required for treatment as determined by
the medical practitioner, pharmacist, practitioner or veterinarian; or
(b)
compounded by a pharmacist in a quantity not greater than that prescribed by
regulation for sale in the retail trade, subject to the conditions likewise prescribed or in a quantity for a
particular person or animal as prescribed by a medical practitioner or a dentist or a veterinarian or a
practitioner or a nurse or other person registered under the Health Professions Act, 1974, and referred
to in section 22A, as the case may be,
if such medicine does not contain any component the sale of which is prohibited by this Act or any
component in respect of which an application for registration has been rejected, and is not or has not
been advertised: Provided that the active components of such medicine appear in another medicine
which has been registered under this Act.
[Sub-s. (4) substituted by s. 6 of Act No. 17 of 1979, by s. 7 (c) of Act No. 94 of 1991 and by s. 8 (a) of
Act No. 90 of 1997.]
Wording of Sections
(5) . . . . . .
[S. 14 substituted by s. 1 (1) of Act No. 29 of 1968 and by s. 12 (1) of Act No. 65 of 1974. Sub-s. (5)
deleted by s. 8 (b) of Act No. 90 of 1997.]
Wording of Sections
15. Registration of medicines.—(1) Every application for the registration of a medicine shall be
submitted to the registrar in the prescribed form and shall be accompanied by the prescribed particulars
and samples of the relevant medicine and by the prescribed registration fee.
(2) The registrar shall—
(a)
as soon as possible after receipt by him or her of any such application submit the
application together with any particulars and samples which accompanied the application to the council
for consideration and shall simultaneously inform the applicant in writing that the application has been
so submitted;
(b)
ensure that such an application in respect of medicine which appears on the latest
Essential Drug List or medicine which does not appear thereon but which, in the opinion of the Minister,
is essential for national health is subject to such procedures as may be prescribed in order to expedite
the registration.
[Sub-s. (2) substituted by s. 9 (a) of Act No. 90 of 1997.]
Wording of Sections
(3) (a) If after consideration of any such application and after any investigation or enquiry which it may
consider necessary the council is satisfied that the medicine in question is suitable for the purpose for
which it is intended and complies with the prescribed requirements and that registration of that medicine
is in the public interest, it shall approve of the registration thereof.
(b) If the council is not so satisfied it shall cause the applicant to be notified in writing of the reasons
why it is not so satisfied and cause the applicant to be informed that he or she may within a period of
one month after the date of the notification furnish the registrar with his or her comments on the
council’s reasons for not being so satisfied.
[Para. (b) substituted by s. 9 (b) of Act No. 90 of 1997.]
Wording of Sections
(c) If no such comments are submitted by the applicant within the said period, or if after consideration of
any comments so submitted the council is still not satisfied as aforesaid, it shall reject the application.
(4) When the council has approved of the registration of any medicine the registrar shall register that
medicine and shall enter in the register such particulars in regard to the medicine as are required by this
Act to be so entered and shall issue to the applicant a certificate of registration in the prescribed form in
respect of that medicine.
(5) Every medicine shall be registered under such name as the council may approve.