This document is an excerpt from the EUR-Lex website
Document 62011CN0535
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
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
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
OJ C 13, 14.1.2012, p. 5–5
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
14.1.2012 |
EN |
Official Journal of the European Union |
C 13/5 |
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?