Medicines and Allied Substances
[No. 3 of 2013 51
GOVERNMENT OF ZAMBIA
ACT
No. 3 of 2013
Date of Assent:21st March, 2013
An Act to continue the existence of the Pharmaceutical
Regulatory Authority and re-name it as the Zambia
Medicines Regulatory Authority; provide for the functions
and powers of the Authority; provide for the registration
and regulation of pharmacies, health shops and agroveterinary shops; provide for the registration and
regulation of medicines and allied substances; provide
for the regulation of the manufacture, importation,
exportation, possession, storage, distribution, supply,
promotion, advertising, sale and use of medicines and
allied substances; provide for the regulation and control
of clinical trials; repeal and replace the Pharmaceutical
Act, 2004; and provide for matters connected with, or
incidental to, the foregoing.
[22nd March, 2013
ENACTED by the Parliament of Zambia.
PART I
PRELIMINARY
1. This Act may be cited as the Medicines and Allied
Enactment
Substances Act, 2013.
2. In this Act, unless the context otherwise requires—
“ administer ” means to give a substance to a human being or
animal orally, by injection or by introduction into the body Short title
in any other way or by external application, whether by
direct contact with the body or not;
Interpretation
“ adulterated medicine ” means any medicine—
(a) consisting in whole or in part of any filthy, putrid,
decomposed, deleterious or foreign substance;
(b) that is prepared or stored under unsanitary conditions;
(c) whose container is composed of any poisons or
deleterious substance;
(d) that contains a colouring agent that is not prescribed;
or
(e) that contains any harmful or toxic substance;
“ agro-veterinary shop ” means a place or premises permitted
to sell prescribed veterinary medicinal products and allied
substances under the control of a relevant veterinary
professional as determined by the Authority;