Medicines and Allied Substances Act, 2013 (No. 3 of 2013).

This Act continues the Pharmaceutical Regulatory Authority as the Zambia Medicines Regulatory Authority and provides for certain prohibitions, controls and restrictions relating to medicines and other substances including disinfectants, food supplements and feed additives and supplements. The Act consists of 70 sections divided into 9 Parts: Preliminary (I); The Zambia Medicines Regulatory Authority (II); Registration and Regulation of Pharmacies, Health Shops and Agro-Veterinary Shops (III); Licences, Import and Export Permit (IV); Registration of Medicines and Allied Substances (V); Regulation of Clinical Trials (VI); The National Drug Quality Control Laboratory (VII); Inspections (VIII); General Provisions (IX). The Act is completed by 2 Schedules.
Medicine is defined in section 2 as to include animal drugs. “ Animal” in this Act has the meaning assigned to it in the Animal Health Act, 2010. The Pharmaceutical Regulatory Authority shall be a body corporate and shall, among other things: (a) grant pharmaceutical licences and marketing authorizations; (b) regulate and control the manufacture, importation, exportation, distribution and placing on the market of medicines and allied substances; (c) register pharmacies, health shops and agro-veterinary shops.
There is constituted a Board of the Authority which shall carry out certain supervisory and advisory functions and establish and issue guidelines and standards for purposes of this Act. A person shall not: manufacture, distribute or deal in any medicine or allied substance without a pharmaceutical licence; import or export any medicine or allied substance without a permit; place on the market, advertise, market, manufacture, sell, import, supply, administer or deal in any manner with any medicine or allied substance without a marketing authorization. The Act also establishes a National Drug Quality Control Laboratory, which shall be managed by the Authority.