Case C-535/11: Judgment of the Court (Fourth Chamber) of 11 April 2013 (request for a preliminary ruling from the Landgericht Hamburg — Germany) — Novartis Pharma GmbH v Apozyt GmbH (Request 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)
Date: 2013-04-11
Institutions: Court of Justice
Subjects: Germany, drug surveillance, interpretation of the law, medicinal product








C_2013156EN.01000901.xml










1.6.2013   


EN


Official Journal of the European Union


C 156/9





Judgment of the Court (Fourth Chamber) of 11 April 2013 (request for a preliminary ruling from the Landgericht Hamburg — Germany) — Novartis Pharma GmbH v Apozyt GmbH
(Case C-535/11) (1)

(Request 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)
2013/C 156/13
Language of the case: German

Referring court

Landgericht Hamburg

Parties to the main proceedings


Applicant: Novartis Pharma GmbH

Defendant: Apozyt GmbH

Re:

Request for a preliminary ruling — Landgericht Hamburg — Interpretation of the Annex to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1) — Meaning of ‘hergestellt’ (‘developed’ in the English version) in point 1 of that Annex — Whether that term covers the drawing off of liquid medicinal products from the original containers and the transfer into ready-to-use syringes

Operative part of the judgment

Activities such as those at issue in the main proceedings, provided that they do not result in a modification of the medicinal product concerned and are carried out solely on the basis of individual prescriptions calling for processes of such a kind — a matter which falls to be determined by the referring court —, do not require a marketing authorisation under Article 3(1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, but remain, in any event, subject to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010.


(1)  OJ C 13, 14.1.2012.