TITLE V U.K. LABELLING AND PACKAGE LEAFLET

Article 57 U.K.

Notwithstanding Article 60, Member States may require the use of certain forms of labelling of the medicinal product making it possible to ascertain:

• the price of the medicinal product,

• the reimbursement conditions of social security organizations,

• the legal status for supply to the patient, in accordance with Title VI,

• [F1 authenticity and identification in accordance with Article 54a(5).]

[F2 For medicinal products authorised under Regulation (EC) No 726/2004, Member States shall, when applying this Article, observe the detailed guidance referred to in Article 65 of this Directive.]

Textual Amendments

F1 Substituted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).

F2 Inserted 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.