SCHEDULE 1MARKETING AUTHORISATIONS
PART 7Labelling and package leaflets
Labelling with all the information on the immediate packagingI147
1
If it is reasonably practicable to do so, the following must be provided on the immediate packaging, in legible characters—
a
the name, strength and pharmaceutical form of the veterinary medicinal product;
b
the name and strength of each active substance, and of any excipient if this is required under paragraph 2 of the summary of product characteristics;
c
the route of administration (if not immediately apparent);
d
the batch number;
e
the expiry date;
f
the words “For animal treatment only” and if appropriate, “To be supplied only on veterinary prescription”;
g
the contents by weight, volume or number of dose units;
h
the marketing authorisation number;
i
the name and address of the marketing authorisation holder or, if there is a distributor authorised in the marketing authorisation, that distributor;
j
a suitably labelled space to record discard date (if relevant);
k
the target species;
l
the distribution category;
m
the words “Keep out of reach of children”;
n
storage instructions;
o
the in-use shelf-life (if appropriate);
p
for food-producing species, the withdrawal period for each species or animal product concerned;
q
any warning specified in the marketing authorisation;
r
disposal advice;
s
full indications;
t
dosage instructions;
u
contra-indications;
v
further information required in the marketing authorisation;
w
if the product is one that requires a dose to be specified for the animal being treated, a space for this.
2
If all this is on the immediate packaging, there is no need for any outer packaging or a package leaflet.