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;