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The Veterinary Medicines Regulations 2005

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Labelling with all the information on the immediate packaging

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47.—(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 necessity for any outer packaging or a package leaflet.

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