SCHEDULE 1MARKETING AUTHORISATIONS

PART 7Labelling and package leaflets

Labelling with all the information on the immediate packagingI147

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 need for any outer packaging or a package leaflet.