Article 43

The following information, which shall conform with the particulars and documents provided pursuant to Article 5 and be approved by the competent authorities, shall appear in legible characters on containers and outer packages of medicinal products: 1. name of the veterinary medicinal product, which may be a brand name or a non-prprietary name with or without a trade-mark or name of the manufacturer or a scientific name or formula with or without a trade-mark or name of the manufacturer; 2. next to the name of the veterinary medicinal product, its qualitative and quantitative composition expressed in active ingredients per dose-unit or as a percentage, according to the pharmaceutical form and, in the cases referred to in the second paragraph of Article 12, the tracer substances. The international non-proprietary names recommended by the World Health Organization shall be used wherever they exist; 3. reference number for production identification (manufacturer's batch number); 4. marketing authorization number; 5. name or corporate name and permanent address or registered place of business of the person responsible for marketing and of the manufacturer, if different; 6. the species of animal for which the veterinary medicinal product is intended ; the method and route of administration; 7. the withdrawal period, even if this is nil, in the case of veterinary medicinal products administered to animals intended for human consumption; 8. the date of expiry, if the shelf life is less than three years; 9. special storage precautions, if any; 10. particulars required to be indicated pursuant to the first paragraph of Article 12, if any; 11. the words "For animal treatment only". The pharmaceutical form and the contents by weight, volume or number of dose-units need only be shown on the outer package. The provisions of Part 1, A of the Annex to Council Directive 81/852/EEC, in so far as they concern the qualitative and quantitative composition of veterinary medicinal products in respect of active ingredients, shall apply to the particulars provided for in point 2.

← art_42__para · All articles · art_43__para →

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