art_12__para

The authorization provided for in Article 4 may require the person responsible for marketing to indicate on the container and/or the outer wrapping and the package insert, where the latter is required, other particulars essential for safety or health protection, including any special precautions relating to use and any other warnings resulting from the clinical and pharmacological trials prescribed in point 10 of Article 5 or from experience gained during the use of the veterinary medicinal product once it has been marketed. The authorization may also require the inclusion of a tracer substance in the veterinary medicinal product.

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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.