30
No.
of 2013]
Medicines and Allied Substances
49. (1) A person shall not conduct a clinical trial involving a
medicine or allied substance without a clinical trial certificate.
Prohibition
of
conducting
clinical trial
without
certificate
Application
for clinical
trial
certificate
(2) A person who contravenes subsection (1) commits an offence
and is liable, upon conviction, to a fine not exceeding three million
penalty units or imprisonment for a period not exceeding five years,
or to both.
50. (1) A person who intends to conduct a clinical trial shall
apply to the Authority for a clinical trial certificate in the prescribed
manner and form upon payment of the prescribed fee.
(2) The Authority shall reject an application for a clinical trial
certificate if—
(a) the application does not meet the requirements of this
Act;
(b) the activity to be carried out contravenes any law in force;
(c) the clinical trial certificate previously held by the applicant
has been revoked by the Authority;
(d) the applicant submits false information in relation to the
requirements for the application;
(e) the premises to be used for the clinical trials is not suitable
for the intended purpose; or
(f) there is some risk to the health or well-being of a participant
and the potential benefit of the clinical trial does not
significantly outweigh that risk.
(3) The Authority shall, where it rejects an application under
subsection (1), inform the applicant accordingly and give the reasons
therefor.
(4) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria for the regulation of persons under subsection
(1);
(b) the procedure for applying for a clinical trial certificate
and the grant, amendment, renewal, transfer and
revocation of a clinical trial certificate;
(c) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer or revocation of
a clinical trial certificate; and
(d) such other matters as are necessary or incidental to the
effective regulation of clinical trials under this Part.
51. (1) The Authority shall, within ninety days of receipt of an
application under section fifty, issue the applicant with a clinical