Article 4

1. No veterinary medicinal product may be marketed in a Member State unless authorization has previously been issued by the competent authority in that Member State. 2. No veterinary medicinal product may be administered to animals unless the authorization referred to above has been issued, except for tests of veterinary medicinal products referred to in point 10 of Article 5.

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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.