(6) The registrar shall allocate to every medicine registered under this Act a registration number which
shall be recorded in the register opposite the name of such medicine and which shall be stated in the
certificate of registration issued in respect of such medicine.
(7) Any registration under this section, including the registration of medicines already registered, shall
be valid for a period of five years and may be made subject to such conditions as may with regard to the
succeeding provisions of this section be determined by the council.
[Sub-s. (7) substituted by s. 9 (c) of Act No. 90 of 1997.]
Wording of Sections
(8) No condition shall be imposed under subsection (7) whereby the sale of the medicine in question by
any person other than a pharmacist is prohibited or until after the applicant has in writing been notified
by the registrar that the imposition of such condition is contemplated and invited to submit written
representations to the council in regard to the matter.
(9) If no such representations are lodged with the registrar by the applicant concerned within a period of
one month after the receipt by him or her of any notification referred to in subsection (8), or if after
consideration of any such representations the council is still of the opinion that the condition in question
should be imposed, the council shall direct the registrar to register the medicine concerned subject to
the said condition.
[Sub-s. (9) substituted by s. 9 (d) of Act No. 90 of 1997.]
Wording of Sections
(10) Notice of the rejection of an application under this section in respect of a medicine referred to in
subsection (3) of section 14 shall be given in the Gazette by the registrar—
(a)
if no appeal is lodged against the rejection within the period referred to in section 24,
as soon as possible after the expiration of that period; or
[Para. (a) substituted by s. 8 of Act No. 94 of 1991.]
Wording of Sections
(b)
if any appeal so lodged is dismissed, as soon as possible after the decision
dismissing the appeal has been given.
(11) The registrar shall as soon as possible after the date of expiry of the appropriate period referred to
in section 14 (3) publish in the Gazette the prescribed particulars in respect of all applications for
registration received by him or her prior to such date.
[Sub-s. (11) substituted by s. 9 (e) of Act No. 90 of 1997.]
Wording of Sections
(12) For the purposes of this section, “Essential Drug List” means the list of essential drugs included in
the latest edition of the official publication relating to guidelines for standard treatment which is compiled
by the Department of Health.
[S. 15 amended by s. 2 of Act No. 29 of 1968 and substituted by s. 13 of Act No. 65 of 1974. Sub-s. (12)
added by s. 9 ( f ) of Act No. 90 of 1997.]
Wording of Sections
15A. Amendment of entries in register.—(1) The entry made in the register with respect to any
medicine may on application by the holder of the certificate of registration issued in respect of such
medicine be amended by the registrar with the approval of the council.
(2) Application for the amendment of an entry in the register shall be made to the registrar on the
prescribed form and shall be accompanied by the prescribed application fees.
(3) The registrar shall as soon as possible after the receipt of any such application submit the
application to the council for consideration.
(4) If the council grants its approval in respect of any application submitted to it in terms of subsection
(3) the registrar shall make the required amendments in the register and, if necessary, cancel the
existing certificate of registration in respect of such medicine and issue a new certificate of registration
on the prescribed form to the applicant in respect of such medicine.
[S. 15A inserted by s. 3 of Act No. 20 of 1981.]
15B. Transfer of certificates of registration.—(1) certificate of registration may with the approval of the
council be transferred by the holder thereof to any other person.
(2) Application for approval of the transfer of a certificate of registration shall be made to the registrar on
the prescribed form and shall be accompanied by the certificate of registration in question and the
prescribed application fees.
(3) The registrar shall as soon as practicable after the receipt of any such application submit the
application to the council for consideration.
(4) If the council grants any application submitted to it in terms of subsection (3) the registrar shall make
the necessary entries in the register relating to the person to whom the certificate of registration is
transferred, cancel the existing certificate of registration and issue a new certificate of registration on the
prescribed form to such person in respect of the relevant medicine.
[S. 15B inserted by s. 3 of Act No. 20 of 1981.]
15C. Measures to ensure supply of more affordable medicines.—The Minister may prescribe
conditions for the supply of more affordable medicines in certain circumstances so as to protect the
health of the public, and in particular may—
(a)
notwithstanding anything to the contrary contained in the Patents Act, 1978 (Act No.
57 of 1978), determine that the rights with regard to any medicine under a patent granted in the