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.