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