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Subsection 4: Marketing authorisation issued by the European Union

Article R5121-53 of the French Public Health Code

Where a marketing authorisation issued by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency provides that the medicinal product is subject to prescription, the Director General of the Agence nationale de sécurité du médicament…

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