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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use article 65 CELEX: 02001L0083-20250101 In consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning in particular: (a) the wording of certain special warnings for certain categories of medicinal products; (b) the particular information needs relating to non-prescription medicinal products; (c) the legibility of particulars on the labelling and package leaflet; (d) the methods for the identification and authentication of medicinal products; (e) the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated; (f) harmonised provisions for the implementation of Article 57. |