Paragraph 51 Ampoules

(1)

In the case of ampoules or other unit dose forms, where the container cannot bear legibly the required information, only the following information must be shown on the immediate packaging—

(a)

the name of the veterinary medicinal product;

(b)

the name and strength of the active ingredient;

(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”.

(2)

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, except that the ampoule need not refer to the package leaflet.