38
No.
of 2013]
Medicines and Allied Substances
(2) A person shall not manufacture, import, sell or supply any
medical device that does not meet the prescribed standards of quality.
(3) A person who contravenes subsection (1) or (2) commits an
offence and is liable, upon conviction, to a fine not exceeding two
million penalty units or to imprisonment for a period not exceeding
four years, or to both.
General
penalty
66. A person who contravenes a provision of this Act for
which a specific penalty is not provided for under this Act, commits
an offence and is liable, upon conviction, to a fine not exceeding
one million penalty units or to imprisonment for a period not exceeding
three years, or to both.
Offence by
body
corporate or
unincorporate
body
67. Where an offence under this Act is committed by a body
corporate or an unincorporate body, every director or manager of
the corporate or unincorporate body is liable, upon conviction, as if
the director or manager had personally committed the offence, unless
the director or manager proves to the satisfaction of the court that
the act constituting the offence was done without the knowledge,
consent or connivance of the director or manager or that the director
or manager took reasonable steps to prevent the commission of the
offence.
Guidelines
68. (1) The Authority may make guidelines for the better
carrying out of the provisions of this Act.
(2) The guidelines referred to in subsection (1) shall, upon
publication in a daily newspaper of general circulation in Zambia,
be binding on all persons regulated under this Act.
Regulations
69. (1) The Minister may, by statutory instrument, make
regulations for the better carrying out of the provisions of this Act.
(2) Without prejudice to the generality of subsection (1), regulations
under that subsection may make provision for—
(a) the prohibition, regulation or restriction of the manufacture
or importation of pharmaceutical preparations and
prescription only medicines;
(b) the required standards for pharmacies, agro-veterinary
shops and health shops, including their operation and the
maintenance, space, equipment and facilities required
for pharmacies, agro-veterinary shops and health shops;
(c) the required standards for the manufacture, supply,
dispensing and the distribution of medicines and allied
substances;