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Case C-535/11: Reference for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 20 October 2011 — Novartis Pharma GmbH v Apozyt GmbH

ECLI:EU:UNKNOWN:62011CN0535

62011CN0535

October 20, 2011
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14.1.2012

Official Journal of the European Union

C 13/5

(Case C-535/11)

2012/C 13/10

Language of the case: German

Referring court

Parties to the main proceedings

Claimant: Novartis Pharma GmbH

Defendant: Apozyt GmbH

Question referred

Does the term ‘developed’ in the introductory sentence of the Annex to Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency extend to processes in which portions only of a medicinal product which has been developed and produced on a ready-to-use basis in accordance with the above procedures are drawn off into another container, after being prescribed and ordered at the time concerned by a doctor, if as a result of the process the composition of the medicinal product is not modified, and therefore in particular to the production of pre-filled syringes which have been filled with a medicinal product which is authorised under the regulation?

Language of the case: German.

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