2; "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; e) that contains any harmful or toxic substance; "Sub-standard medicine" means a product whose composition and ingredients do not meet the approved quality specifications and which may be consequently ineffective and often dangerous to the patient.

5; The Functions of the Authority are to- [...] (c ) regulate and control the manufacture, importation, exportation, distribution and sale of medicines and allied substances; (g) serve and protect the public interest from in all matters relating to the sale of medicines and allied substances; (i) establish, maintain and enforce standards relating to the manufacture, importation, exportation, distribution and sale of medicines and allied substances; (o) do all such things as are connected with, or incidental to, the functions of the Authority under this Act.

6; The Authority may - (a) direct any pharmacy, health shop or agro-veterinary shop or any person providing services relating to the manufacture, importation, exportation, distribution and sale of medicines and allied substances to deliver the services in such a manner as to ensure compliance with this Act;

47; The Minister may, on the recommendation of the Authority, by statutory instrument, make regulations for monitoring the safety of medicines and allied substances.

20(1); A holder of a marketing authorization shall label the primary package or container of a medicine to show- (a) the name and dosage form of the medicine; (b) the name and quality of active pharmaceutical ingredients or in case of a herbal medicine, a botanical, english or other name, and the quantity of each ingredient; (c) the quantity or volume of the medicine per unit pack; (d) the indications and directions for use, including the target species in case of veterinary medicine; (e) the storage instructions; (f) expiry date; (g) the batch number; (h) the marketing authorization number; (i) name and address of the holder of the marketing authorization; (j) suitable coding; (k) the name of the manufacturer, if different from the holder of marketing authorization; (l) category of distribution; (m) precautionary statement; "keep away from reach of children"; (n) in case of veterinary medicine, a statement "For veterinary use only"; (o) any other information required by the authority for the purpose of this Act.

21; An original container of medicine shall be accompanied by a package insert print printed in legible letters in English stating the - (a) the name and dosage form of the medicine ...[...]

2; "label" means to affix to, or otherwise display on, a container or package, a notice describing the ingredients and contents thereof; "package" means anything in or by which any medicine, herbal medicine, therapeutic substance or allied substance is enclosed, covered or contained, and includes primary and secondary packaging.

43; The Minister may, on the recommendation of the Authority, provide by statutory instruments.

44(2); Any medicine sold in a place other than a pharmacy, health facility or animal health facility shall be sold in the original package labelled by the manufacturer with: full instructions for use; indications, contra indications, warnings and precautions; and any other information as the Minister may provide, by statutory instrument, on the recommendation of the Authority.

69(2); The Minister may make provisions for the advertising, promotion and labelling of medicines and allied substances.
According to section 2 of the Statutory instruments no. 91 of 2018 The Medicines and Allied Substances (Pharmaceutical Licence) Regulations, 2018, primary repackaging means the part of manufacturing that involves packing of the finished dosage form or device into its primary packaging material; re-packing of medicine means the act of removing a preparation from its original primary container and placing it into a patient pack, but does not include the act of cutting a blister pack; secondary repackaging means the part of manufacturing that involves repacking of medicines into secondary or tertiary packaging material which does not come in direct contact with the finished dosage form or device.
Sections 20 and 21 of the Statutory instruments no. 79 of 2019 The Medicines and allied substances (Marketing authorisation of medicines) Regulations, 2019, prescribe detailed labelling and packaging requirements for medicines

12(6); Where a license is revoked, the products on the premises and the recalled products shall be quarantined as directed by the Authority at the former licensee's cost, including disposal of the products.

13(1); a licensee shall store a withdrawn, obsolete, unwanted, expired medicines or allied substance in an appropriate container clearly labelled "for destruction within a specified period of time” as stipulated in the guidelines.

14; The Authority shall, where it establishes that the permit holder stocks medicines or allied substances under insanitary conditions, direct the permit holder to dispose of the medicines or allied substances at the permit holder’s cost

69(2); The Minister may make provisions for the disposal of obsolete, expired or unwanted medicines or allied substances, in consultation with the Zambia Environmental Management Agency; and for the recall or withdrawal of medicines and allied substances that do not meet the prescribed standards of quality, efficacy and safety.

59(2) and (3); concerning the prohibition of manufacture, import, export of sub-standards or counterfeit medicines, 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; in addition to the penalty provided in subsection (2), the court before which a person is convicted of an offence under this section may order that any medicines or allied substances in respect of which the offence is committed be forfeited to the State to be destroyed.

60(2); concerning the prohibition of supply of expired medicines, a person who contravenes subsection (1) commits an offence and is liable, upon conviction, to a fine not exceeding one million penalty units or to imprisonment for a period not exceeding three years, or to both; in addition to the penalty provided for in subsection (2), the court before which a person is convicted of an offence under this section may order that the medicines or allied substances in respect of which the offence is committed be forfeited to the State to be destroyed. According to section

61(2); of the concerning the labelling and packaging, a person who contravenes subsection (1) commits an offence and is liable, upon conviction, to a fine not exceeding one million penalty units or to imprisonment for a period not exceeding three years, or to both.