Judgment of the Court (Fourth Chamber), 11 April 2013
Novartis Pharma GmbH v Apozyt GmbH
Request for a preliminary ruling from the Landgericht Hamburg
Reference 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
Case C‑535/11
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published in the electronic Reports of Cases (Court Reports - general)
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Opinion
ECLI:EU:C:2013:53 |
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Judgment
ECLI:EU:C:2013:226 |
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