52
No. 3 of 2013]
Act No. 27 of
2010
Act No. 45 of
2010
Medicines and Allied Substances
“ allied substances ” include acaricides, cosmetics,
disinfectants, food supplements, feed additives and
supplements, medical and surgical sundries, medical devices
and condoms;
“ animal ” has the meaning assigned to it in the Animal Health
Act, 2010;
“ animal health facility ” has the meaning assigned to it in the
Veterinary and Veterinary Para-Professions Act, 2010;
“ assemble ” in relation to a medicine, means enclosing the
medicine or allied substance of the same description in a
container before the medicine or allied substance is sold or
supplied;
“ Authority ” means the Zambia Medicines Regulatory
Authority provided for under section three;
“ biological product ” includes vaccine, immune sera, antitoxin, anti-venom, toxoid, blood and blood components,
allergy products used in the prevention, treatment or cure
of disease or condition in human beings and animals
synthesised from living organisms or other product;
“ Board ” means the Board of the Authority constituted under
section seven;
“ certificate of registration ” means the certificate of
registration of a pharmacy;
“ Chairperson ” means the person appointed as Chairperson
of the Board under section seven;
“ clinical trial ” means the systematic study involving human
participants or animal subjects that serves to answer the
efficacy of a medicine, biological products or method of
prevention or treatment;
“ committee ” means a committee of the Board established
under section ten;
“ cosmetic ” means any substance manufactured or sold for
use in cleansing, beautifying or altering the hair, eyes, teeth
or nails, or complexion of the skin, and includes deodorants
and perfumes;
“ counterfeit medicine or allied substance ” means a medicine
or allied substance which is deliberately or fraudulently
mislabeled or misrepresented with respect to identity or
source, or a medicine or allied substance which—
(a) has wrong ingredients;
(b) contains active ingredients or not;
(c) has insufficient or excess active ingredients; or
(d) has fake packaging;