OpenLegislation

Article 65 F1

United Kingdom

Original text. Later amendments are not shown.

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.

Annotations

Textual amendments

F1

Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.