1.

Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 29 is, without prejudice to his relationship with the holder of the authorization referred to in Article 24, responsible, in the context of the procedures referred to in Article 33, for ensuring that: (a) in the case of veterinary medicinal products manufactured within the Member State concerned, each batch of veterinary medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization; in the case of veterinary medicinal products coming from third countries, each production batch imported has undergone in the importing country a full qualitative analysis, a quantitative analysis of at least all the active ingredients and all the other tests or checks necessary to ensure the quality of veterinary medicinal products in accordance with the requirements of the marketing authorization. Batches of veterinary medicinal products which have undergone such controls in a Member State shall be exempt from the above controls if they are imported into another Member State, accompanied by the control reports signed by the qualified person. A Member State may relieve the qualified person of responsibility for the controls prescribed under (b) for imported veterinary medicinal products which are to remain in that Member State, if appropriate arrangements have been made with the exporting country to ensure that these controls have been carried out in the exporting country. Where these products are imported in the packaging in which they are to be sold by retail, Member States may allow exceptions to the requirements laid down in Article 25.

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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.