Article 48

Member States shall take all appropriate measures to ensure that where a package insert is included with a veterinary medicinal product it relates solely to that product. The package insert shall contain at least the following information, which shall conform with the particulars and documents provided pursuant to Article 5 and be approved by the competent authorities: (a) name or corporate name and permanent address or registered place of business of the person responsible for marketing and of the manufacturer, if different; Member States may require a package insert to be included with veterinary medicinal products. name of the veterinary medicinal product and a statement of its active ingredients expressed qualitatively and quantitatively. The international non-proprietary names recommended by the World Health Organization shall be used wherever they exist; the main therapeutic indications, contra-indications and side-effects in so far as these particulars are necessary for the use of the veterinary medicinal product; the species of animal for which the veterinary medicinal product is intended, the dosage for each species, the method and route of administration and advice on correct administration, if necessary; the withdrawal period, even if this is nil, in the case of veterinary medicinal products administered to animals intended for human consumption; special storage precautions, if any; particulars required to be indicated pursuant to the first paragraph of Article 12, if any. Such particulars must appear in the language or languages of the country in which the product is marketed. The other information shall be clearly separate from the abovementioned particulars.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.