CHAPTER IIMARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS
Section 4Labelling and package leaflet
Article 10Labelling of the immediate packaging of veterinary medicinal products
1
The immediate packaging of a veterinary medicinal product shall contain the following information and shall, subject to Article 11(4), contain no information other than:
a
the name of the veterinary medicinal 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 name 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
route of administration; and
i
if applicable, the withdrawal period, even if such period is zero.
2
The information referred to in paragraph 1 of this Article shall appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms common throughout the Union as listed in accordance with Article 17(2).
3
Notwithstanding paragraph 1, a Member State may decide that, on the immediate packaging of a veterinary medicinal product made available in its territory, an identification code shall be added to the information required under paragraph 1.