TITLE V

LABELLING AND PACKAGE INSERT
Article 58
1
Except in the case of the medicinal products referred to in Article 17(1), the competent authority shall approve the immediate packaging and outer packaging of veterinary medicinal products. Packaging shall bear the following information, which shall conform with the particulars and documents provided pursuant to Articles 12 to 13d and the summary of product characteristics, and shall appear in legible characters:
a
The name of the medicinal product, followed by its strength and pharmaceutical form. The common name shall appear if the medicinal product contains only one active substance and its name is an invented name;
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 the common names;
c
Manufacturer's batch number;
d
Marketing authorization number;
e
Name or corporate name and permanent address or registered place of business of the marketing authorisation holder and, where appropriate, of the representative designated by the marketing authorisation holder;
f
The species of animal for which the veterinary medicinal product is intended; the method and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;
g
The withdrawal period for veterinary medicinal products to be administered to food-producing species, for all the species concerned and for the various foodstuffs concerned (meat and offal, eggs, milk, honey), including those for which the withdrawal period is zero;
h
Expiry date, in plain language;
i
Special storage precautions, if any;
j
Specific precautions relating to the disposal of unused medicinal products or waste derived from veterinary medicinal products, where appropriate, as well as a reference to any appropriate collection system in place;
k
Particulars required to be indicated pursuant to Article 26(1), if any;
l
The words
‘
For animal treatment only
’
or, in the case of the medicinal products referred to in Article 67, the words
‘
For animal treatment only — to be supplied only on veterinary prescription
’ .
2
The pharmaceutical form and the contents by weight, volume or number of dose-units need only be shown on the outer package.
3
The provisions of Part 1, A of Annex I, in so far as they concern the qualitative and quantitative composition of veterinary medicinal products in respect of active substances, shall apply to the particulars provided for in paragraph 1(b).
4
The particulars mentioned in paragraph 1(f) to (l) shall appear on the outer package and on the container of the medicinal products in the language or languages of the country in which they are placed on the market.
5
In the case of medicinal products that have been granted a marketing authorisation under Regulation (EC) No 726/2004, Member States may permit or require that the outer packaging bear additional information concerning distribution, possession, sale or any necessary precautions, provided that such information is not in infringement of Community law or the terms of the marketing authorisation, and is not promotional.
This additional information shall appear in a box with a blue border to separate it clearly from the information referred to in paragraph 1.
Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Inserted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.