TITLE VLABELLING AND PACKAGE LEAFLET

F1Article 65

In consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning in particular:

  1. (a)

    the wording of certain special warnings for certain categories of medicinal products;

  2. (b)

    the particular information needs relating to non-prescription medicinal products;

  3. (c)

    the legibility of particulars on the labelling and package leaflet;

  4. (d)

    the methods for the identification and authentication of medicinal products;

  5. (e)

    the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated;

  6. (f)

    harmonised provisions for the implementation of Article 57.