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 (c. 83)

TITLE V U.K. LABELLING AND PACKAGE LEAFLET

[F1 Article 65 U.K.

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.]

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.