SCHEDULE 1Marketing authorisations F1in Great BritainF2in Northern Ireland
PART 7Labelling and package leaflets
F3Labelling of the outer packaging of veterinary medicinal products
49.
(1)
The following information must be provided on any outer packaging of a veterinary medicinal product—
(a)
the information referred to in paragraph 48(1);
(b)
the contents by weight, volume or number of the immediate packaging units of the veterinary medicinal product;
(c)
a warning that the veterinary medicinal product must be kept out of the sight and reach of children;
(d)
a warning that the veterinary medicinal product is “for animal treatment only”;
(e)
a recommendation to read the package leaflet, if there is one;
(f)
in the case of a veterinary medicinal product not subject to a veterinary prescription, the indication for use;
(g)
the marketing authorisation number.
(2)
The information referred to in sub-paragraph (1) must appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms.
Products with immediate and outer packaging49.
(1)
If it is not reasonably practicable to have all the required information on the immediate packaging then this paragraph applies.
(2)
The immediate packaging must have at least the following information—
(a)
the name of the veterinary medicinal product, including its strength and pharmaceutical form;
(b)
the name and proportion of each active substance, and of any excipient if knowledge of the excipient is needed for safety reasons;
(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 words “Keep the container in the outer carton”.
(3)
In addition, the immediate packaging must have as much of the required information as is reasonably practicable.
(4)
The outer packaging must contain all the required information if it is reasonably practicable to do this, and if it is not reasonably practicable to do this a package leaflet must be supplied with the product in accordance with the following paragraph.