TITLE VLABELLING AND PACKAGE LEAFLET

Article 57

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,

  • F2authenticity and identification in accordance with Article 54a(5).

F1For 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.