Court of Justice 11 April 2013, Case C-535/11: Judgment of the Court (Fourth Chamber) of 11 April 2013 (request for a preliminary ruling from the Landgericht Hamburg — Germany) — Novartis Pharma GmbH v Apozyt GmbH (Request for a preliminary ruling — Regulation (EC) No 726/2004 — Medicinal products for human use — Procedure for authorisation — Requirement for authorisation — Concept of medicinal products ‘developed’ by means of certain biotechnological processes, as referred to in point 1 of the Annex to that regulation — Repackaging process — Injectable solution distributed in single-use vials containing a larger quantity of the therapeutic solution than that actually used for the purposes of medical treatment — Part of the content of such vials drawn off, on prescription by a doctor, into syringes pre-filled with the prescribed dose, without any modification of the medicinal product)

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