and such drug shall not be made available or sold to the general public without the said prescription; “primary packaging material” means packaging material that come in direct contact with the product e.g. bottle, blister, alufoils,etc; “principal display panel” means the part of a package or label that is most likely to be displayed, presented, shown or examined under customary conditions of display for retail sale; “proper name” means, with reference to a drug, the name, strength and pharmaceutical form; “secondary packaging material” means packaging material in which primary packaging material is enclosed; “tertiary packaging material” means outer carton in which multiples of saleable units are packed i.e. shipper carton; “therapeutic agent” means a chemical substance that is used for the treatment or mitigation of a disease condition or ailment; “withdrawal period” means the period between the last dose of a drug and the time when the drug or its metabolite is depleted to acceptable maximum residue limit (MRL) in the edible products (meat, milk or egg) of the animal. 22. Citation. These Regulations shall be cited as the Drug Labelling Regulations 2005. MADE at Abuja this day of DR. ADEM YOG ADEM Chairman, Governing Council ational Agency for Food and Drug Administration and Control (AFDAC) 11 2005

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