Food and Drugs Act, /992
P.N.D.C.L. 3058
(2) The Board shall suspend or may cancel a licence issued under subsection (1) if an
information submitted in respect of the registration changes or is found to have been inaccurate.
(3) An applicant may at any time after suspension or cancellation of a registration resubmit new information on the drug, cosmetic, device or chemical substance.
(4) A person responsible for the registration of a drug, cosmetic, device or chemical
substance who fails to inform the Board of a change in the information submitted for its
registration commits an offence.
21. Renewal of registration and licences
(1) A registration and licence made or issued under this Act may be renewed.
(2) An application for renewal under subsection (1) shall be accompanied with the
prescribed particulars.
22. Drugs not to be distributed as samples
(1) A person who, without authority from the Board, distributes a drug as sample
commits an offence.
(2) Subsection (I) does not apply to the distribution of samples of drugs to physicians,
dentists, veterinary surgeons, pharmacists, midwives, nurses or medical assistants.
23. Clinical trials and tests
(I) A person shall not in the course of business carried on by that person manufacture,
sell, supply or distribute a drug or chemical substance for the purpose of clinical trial test
of drugs on animals unless a clinical trial certificate or animal trial certificate has been
issued for it by the Board.
(2) A person who carries out a clinical trial test of a new drug on humans or animals in
the absence of documentary evidence that human or animal pharmocodynamic and
pharmacokinetic studies on health volunteers have been properly carried out, commits an
offence.
(3) An application for a clinical trial certificate or an animal trial certificate shall be
made to the Board in the prescribed form and may be granted subject to the conditions
determined by the Board.
24. Registration of herbal and homeopathic drugs
(1) A person shall not manufacture, prepare, supply, sell, distribute, export or import a
herbal medicine or homeopathic drug, unless the herbal medicine or homeopathic drug has
been registered with the Board.
(2) The Regulations may prescribe particulars to be provided for the registration of
herbal medicines and homeopathic drugs under subsection (1).
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[Issue I]