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Chapter II · MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS  ›  Section 4 · Labelling and package leaflet › Article 12

Labelling of small immediate packaging units of veterinary medicinal products

1.   By way of derogation from Article 10, immediate packaging units which are too small to contain in a readable form the information referred to in that Article shall contain the following information and shall contain no information other than:

(a)

the name of veterinary medicinal product;

(b)

the quantitative particulars of the active substances;

(c)

the batch number, preceded by the word ‘Lot’;

(d)

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

2.   The immediate packaging units referred to in paragraph 1 of this Article shall have an outer packaging containing information required in Article 11(1), (2) and (3).

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