Reference for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 20 October 2011 — Novartis Pharma GmbH v Apozyt GmbH

(Case C-535/11)

2012/C 13/10

Language of the case: German

Referring court

Landgericht Hamburg

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 (1) 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?

(1)  OJ 2004 L 136, p. 1.