Paragraph 6 Labelling

(1)

The product must be clearly labelled as being exempt from the requirements of these Regulations in relation to a marketing authorisation.

(2)

The labelling must show the following—

(a)

the name of the veterinary product, including, if it is part of the name, its strength and pharmaceutical form;

(b)

the authorisation number of the manufacturer;

(c)

the name and strength of each active substance;

(d)

the route of administration;

(e)

the batch number;

(f)

the expiry date;

(g)

the words “For animal treatment only”;

(h)

the contents by weight, volume or number of dose units;

(i)

the name and address of the manufacturer;

(j)

the target species;

(k)

the words “Keep out of reach of children”;

(l)

storage instructions;

(m)

the shelf-life after the immediate packaging has been opened for the first time;

(n)

disposal advice;

(o)

full indications, including—

(i)

therapeutic indications;

(ii)

contra-indications;

(iii)

interaction with other medicines and other forms of interaction; and

(p)

dosage instructions.

(3)

If there is insufficient room on the label, the information may instead be in a package leaflet, but the leaflet must contain all the information in the preceding sub-paragraph other than the batch number and the expiry date, but the label on the product must contain at least the following—

(a)

the name of the veterinary medicinal product;

(b)

its active substance and its strength;

(c)

the route of administration;

(d)

the batch number;

(e)

the expiry date; and

(f)

the words “For animal treatment only”.

(4)

This paragraph does not apply until 1st November 2007 in relation to a veterinary medicinal product on the market on 30th October 2005.