Medicines and Allied Substances
[No.
of 2013 23
33. (1) A person shall not manufacture, distribute or deal in
any medicine or allied substance without a pharmaceutical licence.
(2) A person who contravenes subsection (1) 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.
34. (1) A person who intends to manufacture, distribute or deal
in any medicine or allied substance shall apply to the Authority for
a pharmaceutical licence in the prescribed manner and form upon
payment of the prescribed fee.
(2) The Authority shall, within ninety days of the receipt of an
application under subsection (1), issue a pharmaceutical licence to
the applicant if the applicant meets the requirements of this Act.
(3) The Authority shall reject an application which does not
meet the requirements of this Act and inform the applicant of the
reasons for the rejection.
Prohibition
of
manufacture,
distribution,
etc. of
medicine or
allied
substance
without
pharmaceutical
licence
Pharmaceutical
licence
(4) The Minister may, on the recommendation of the Authority,
by statutory instrument, provide for—
(a) the criteria for the licensing of persons under subsection
(1);
(b) the procedure for applying for a pharmaceutical licence
and the grant, amendment, renewal, transfer and
revocation of a pharmaceutical licence;
(c) the terms and conditions attaching to an application, grant,
amendment, refusal, renewal, transfer or revocation of
a pharmaceutical licence; and
(d) such other matters as are necessary or incidental to the
effective regulation of licences under this Part.
(5) The Minister may, on the recommendation of the Authority,
and for the purposes of facilitating the effective implementation
and enforcement of this Act—
(a) exempt certain categories of persons from the application
of some or all of the provisions of this section; and
(b) provide that some or all of the provisions of this section
shall not apply in certain circumstances.
35. (1) A person shall not import any medicine or allied
substance without an import permit.
(2) This section does not apply to any medicine or allied substance
imported by a traveller entering Zambia for the traveller’s use as
Import
permit