The Veterinary Medicines Regulations 2006

Labelling U.K.

6.—(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 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;

(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; and

(o) 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.

Commencement Information

I1 Sch. 6 para. 6 in force at 1.10.2006, see reg. 1