Act No. 13, 2003
MEDICINES AND RELATED SUBSTANCES
CONTROL ACT, 2003
(dd) declaring chemicals or equipment to be controlled chemicals or
controlled equipment for the purpose of controlling the use of those
chemicals or the equipment in the manufacture of Schedule 3,
Schedule 4 and Schedule 5 substances;
(ee)
regulating or prohibiting the manufacture, importation, transshipment
or exportation of controlled chemicals or controlled equipment;
(ff)
prescribing methods of identifying an importer of controlled chemicals
or controlled equipment, the purpose for which those chemicals are,
or the equipment is, used and the quantities of the chemicals or
equipment, which the importer handles annually;
(gg) prescribing the minimum standards for good manufacturing practices
to be followed in the manufacture of medicines;
(hh) prescribing the quantities of unregistered medicine, which may be
compounded and sold in the pharmaceutical trade and the conditions
under which that medicine may be sold;
(ii)
(jj)
prescribing the form and manner of, and the fee for, an application
for the registration of premises and things used, and persons engaged,
in the pharmaceutical business; and
relating to anything that may be registered under this Act.
(2) Not less than three months before a regulation is made under subsection
(1), the Minister must cause the text of that regulation to be published in the Gazette
together with a notice declaring his or her intention to make that regulation and inviting
interested persons to furnish the Minister with any comments on it or with any
representations they may wish to make in regard to that regulation.
(3)
Subsection (2) does not apply in respect of
(a)
a regulation to which, after the provisions of that subsection have been
complied with, the Minister has made changes in consequence of comments
or representations received by him or her in pursuance of the notice issued
under the said subsection (2); or
(b)
a regulation in respect of which the Minister, after consultation with the
Council, is of the opinion that the public interest requires that regulation to
be made without delay.
(4)
Regulations may be made under this section in respect of
(a)
particular medicines or scheduled substances; or
(b)
particular categories of medicines or scheduled substances; or
(c)
medicines or scheduled substances other than particular categories of
medicines or scheduled substances,
and different provisions may be made in respect of different medicines or scheduled
substances or different categories of medicines or scheduled substances.
(5) A regulation made under this section may prescribe penalties for a
contravention of that regulation or failure to comply with it, not exceeding a fine of
N$4 000 or imprisonment for a period not exceeding one year or both the fine and
imprisonment.