48.—(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.