Medicines and Allied Substances
[No.
of 2013 31
trial certificate if—
(a) the application meets the requirements of this Act;
(b) the clinical trial does not contravene any other written
law;
(c) appropriately qualified persons are available to handle the
medicine or allied substance for purposes of the clinical
trial; and
(d) the premises on which the applicant proposes to conduct
the clinical trials are suitable for the intended purpose.
(2) A certificate granted under this section shall be valid for
such period as shall be specified in the certificate.
Grant of
clinical trial
certificate
52. The Authority shall inspect clinical trial sites during the
course of the trial and at such intervals as it may determine.
53. (1) The Authority shall keep and maintain a Register of
Clinical Trial Certificates issued under this Act in which it shall
enter the names and other details relating to clinical trials.
(2) The Register referred to in subsection (1) shall be kept at
the offices of the Authority and shall be open to inspection by the
public at such times and on such conditions, including the payment
of a fee for inspection, as the Board may determine.
Inspection of
clinical trial
sites
Register of
Clinical Trial
Certificates
PART VII
THE NATIONAL DRUG QUALITY CONTROL LABORATORY
54. (1) There is hereby established the National Drug Quality
Control Laboratory which shall be managed by the Authority and
shall facilitate the regulation of medicines and allied substances
under this Act.
(2) The Authority shall use the Laboratory to—
(a) verify the safety, quality and efficacy of medicines and
allied substances which are manufactured or imported
into the country by persons who are authorised or
licenced under this Act;
(b) examine, analyse and conduct research on medicine and
allied substances;
(c) provide laboratory services to the general public;
(d) provide practical training for personnel in the analysis of
medicines and allied substances; and
(e) perform such other functions relating to the analysis of
medicines and allied substances as it considers
necessary.
(3) The Authority shall charge such fees for the analysis of
medicines and services provided by the Laboratory as it may
National
Drug Quality
Control
Laboratory