Article 39

1. The supervisory authorities shall have responsibility for verifying on behalf of the Community that the person responsible for placing the veterinary medicinal product on the market, or manufacturer or importer from third countries satisfies the requirements laid down in Chapter V of Directive 81/851/EEC and for exercising supervision over such persons in accordance with Chapter VI of Directive 81/851/EEC. 2. Where, in accordance with the second paragraph of Article 39 of Directive 81/851/EEC, the Commission is informed of serious differences of opinion between Member States as to whether the person responsible for placing the veterinary medicinal product on the market or a manufacturer or importer established within the Community is satisfying the requirements referred to in paragraph 1, the Commission may, after consultation with the Member States concerned, request an inspector from the supervisory authority to undertake a new inspection of the aforementioned person, the manufacturer or the importer; the inspector in question may be accompanied by an inspector from a Member State which is not party to the dispute and/or by a rapporteur or expert nominated by the Committee. 3. Subject to any arrangements which may have been concluded between the Community and third countries in accordance with the second paragraph of Article 38, the Commission may, upon receipt of a reasoned request from a Member State, the Committee for Veterinary Medicinal Products, or on its own initiative, require a manufacturer established in a third country to submit to an inspection. The inspection shall be undertaken by appropriately qualified inspectors from the Member States, who may, if appropriate, be accompanied by a rapporteur or expert nominated by the Committee. The report of the inspectors shall be made available to the Commission, the Member States and the Committee for Veterinary Medicinal Products.

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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.