(2) Where a drug is not manufactured by the person whose name appears on the label, the
name and location address of the manufacturer shall be indicated by a phrase that reveals the
connection with the person e.g. “Manufactured by……….for…………..”., ‘Manufactured
for…………by……………..”, or any other
wording that expresses the facts.
6.
Display of proper name, brand name etc.
(1) The packaging components of a drug shall bear the name, active ingredients, strength
and dosage form of the drug.
(2) The outer and inner labels of a drug shall show the generic name and strength thereof.
(3) Where a drug is branded, the generic and brand names shall be reflected on the outer
and inner labels.
(4) The name shall prominently appear on the principal display panel of the package to
aid accurate identification.
(5) Where a drug contains a single active ingredient, the common or generic name shall
appear in conjunction and in close proximity to the brand name (if any) of the drug.
(6) Where a drug contains more than one active ingredient, all the common names shall
appear on the principal display panel of the drug. However, if the drug is packaged in a container
too small to bear this information, it may appear elsewhere on the label.
(7) The location address of the manufacturer of a drug shall be complete on the outer
label, unless the immediate container of the drug contains 5 ml (or equivalents) or less of the
drug product, in which case the address need not be shown on the inner label.
7.
Declaration of net content of drug
(1) The outer label of a drug shall indicate :-
8.
(a)
the net content of the drug in the container in terms of unit weight, measure or
number ; and
(b)
for sterile drugs, a quantitative list of preservatives present therein shall be
indicated where applicable by their generic or common names.
Trade mark
(a)
where a drug product have a trade mark displayed on the label, the
trade mark shall not give a wrong impression of the nature, quality or
substance of the drug product;
(b)
where the trademark registration is in conflict with any regulations or
requirements of the Agency, the latter shall supercede.
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