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.
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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.