SCHEDULE 6EXEMPTIONS FOR SMALL PET ANIMALS
LabellingI16
1
The product must be clearly labelled as being exempt from the requirements of these Regulations in relation to a marketing authorisation.
2
The labelling must show the following—
a
the name of the veterinary product, including, if it is part of the name, its strength and pharmaceutical form;
b
the name and strength of each active substance;
c
the route of administration;
d
the batch number;
e
the expiry date;
f
the words “For animal treatment only”;
g
the contents by weight, volume or number of dose units;
h
the name and address of the manufacturer;
i
the target species;
j
the words “Keep out of reach of children”;
k
storage instructions;
l
the shelf-life after the immediate packaging has been opened for the first time;
m
disposal advice;
n
full indications, including—
i
therapeutic indications;
ii
contra-indications;
iii
interaction with other medicines and other forms of interaction; and
o
dosage instructions.
3
If there is insufficient room on the label, the information may instead be in a package leaflet, but the leaflet must contain all the information in the preceding sub-paragraph other than the batch number and the expiry date, but the label on the product must contain at least the following—
a
the name of the veterinary medicinal product;
b
its active substance and its strength;
c
the route of administration;
d
the batch number;
e
the expiry date; and
f
the words “For animal treatment only”.
4
This paragraph does not apply until 1st November 2007 in relation to a veterinary medicinal product on the market on 30th October 2005.