Article 12

1. Without prejudice to Article 6 of Directive 65/65/EEC, a marketing authorization which has been granted in accordance with the procedure laid down in this Regulation shall be valid 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 3 of Directive 65/65/EEC. The authorized 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 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 medicinal product by the Committee for Proprietary 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.