(b)
(i)
the brand name (where applicable),
(ii)
the generic or common name,
(iii)
lot or batch number,
(iv)
net content,
(v)
manufacture and expiry dates,
(vi)
manufacturer’s name,
(vii)
registration number assigned to it in a manner prescribed by the Agency.
Blister packs.
Where a drug is packed in a container which meets the requirements specified in
these Regulations, each blister strip shall indicate the following:-
(c)
(i)
the brand name (where applicable),
(ii)
the generic or common name,
(iii)
the strength of the drug,
(iv)
lot or Batch number, and
(v)
expiry date.
Bulk drugs.
A drug in a bulk package, except tablets, capsules or other dosage unit forms,
intended for processing, repackaging or use in the manufacture
of another drug shall be exempt from the labeling provisions of these
Regulations, provided that, the label of the bulk drug contains the following
information:
(i)
the brand name (where applicable),
(ii)
the generic or common name,
(iii)
net content,
(iv)
lot or batch number,
(v)
manufacture and expiry dates,
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