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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 article 57 CELEX: 02001L0083-20250101 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,
— authenticity and identification in accordance with Article 54a(5).
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. |