SCHEDULE 1Marketing authorisations
PART 7Labelling and package leaflets
Products with immediate and outer packaging49
1
If it is not reasonably practicable to have all the required information on the immediate packaging then this paragraph applies.
2
The immediate packaging must have at least the following information—
a
the name of the veterinary medicinal product, including its strength and pharmaceutical form;
b
the name and proportion of each active substance, and of any excipient if knowledge of the excipient is needed for safety reasons;
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 words “Keep the container in the outer carton”.
3
In addition, the immediate packaging must have as much of the required information as is reasonably practicable.
4
The outer packaging must contain all the required information if it is reasonably practicable to do this, and if it is not reasonably practicable to do this a package leaflet must be supplied with the product in accordance with the following paragraph.