Article 34

1. Without prejudice to Article 4 of Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (14), and laying down additional provisions for immunological veterinary medicinal products, a marketing authorization which has been granted in accordance with the procedure laid down in this Regulation shall apply throughout the Community. It shall confer the same rights and obligations in each of the Member States as a marketing authorization granted by that Member State in accordance with Article 4 of Directive 81/851/EEC. The authorized veterinary medicinal products shall be entered in the Community Register of Medicinal Products and shall be given a number which must appear on the packaging. 2. The refusal of a Community marketing authorization shall constitute a prohibition on the placing on the market of the veterinary medicinal product concerned throughout the Community. 3. Notification of marketing authorization shall be published in the Official Journal of the European Communities, quoting in particular the date of authorization and the number in the Community Register. 4. Upon request from any interested person, the Agency shall make available the assessment report of the veterinary medicinal product by the Committee for Veterinary Medicinal Products and the reasons for its opinion in favour of granting authorization, after deletion of any information of a commercially confidential nature.

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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.