Court of Justice of the European Union · Judgment
C‑535/11Novartis Pharma GmbH v Apozyt GmbH
- Decided
- 2013-04-11
- ECLI
- ECLI:EU:C:2013:226
- CELEX
- 62011CJ0535
- Finality
- Final, the decision cannot be appealed
The court's own keywords
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.
Interprets
Read from EU:s publikationsbyrå, Cellar (EUR-Lex och CURIA) on 2026-08-22.
The row repeats what the source states. It is not a summary, not a conclusion about any single case and not legal advice.
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