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 manufacturing authorisation number (or, in the case of a product manufactured outside the European Union, the wholesale dealing licence number of the importer), and must contain the following —

(a)

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

(b)

the name and strength of each active substance;

(c)

the route of administration;

(d)

the batch number;

(e)

the expiry date;

(f)

the words “For animal treatment only”;

(g)

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

(h)

the name and address of the manufacturer or importer;

(i)

the target species;

(j)

the words “Keep out of reach of children”;

(k)

storage instructions;

(l)

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

(m)

disposal advice;

(n)

full indications, including—

(i)

therapeutic indications;

(ii)

contra-indications;

(iii)

interaction with other medicines and other forms of interaction;

(o)

dosage instructions.

(3)

This paragraph does not apply in relation to a veterinary medicinal product on the market at the time this Schedule comes into force until 1st November 2007.