Labelling of immediate packaging of veterinary medicinal products48

1

Subject to paragraph 50, the following information must be provided on the immediate packaging of a veterinary medicinal product—

a

the name of the product, followed by its strength and pharmaceutical form;

b

a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;

c

the batch number, preceded by the word “Lot”;

d

the name or company name or logo of the marketing authorisation holder;

e

the target species;

f

the expiry date, in the format ‘mm/yyyy’, preceded by the abbreviation “Exp.”;

g

special storage precautions, if any;

h

the route of administration;

i

if applicable, the withdrawal period, even if such period is zero.

2

Where there is no outer packaging for the product, the information set out in paragraph 49 must be included on the immediate packaging of the veterinary medicinal product.

3

The information referred to in paragraph (1) must appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms.