Court of Justice of the European Union
Judgment of the Court n.º C-535/11 of 11 of April 2013
Article 3º, n.º 1, of Regulation (CE) n.º 726/2004 European Parliament and Council of 31 of March 2004
Reference for a preliminary ruling from the Landgericht Hamburg (Germany) on the Novartis Pharma GmbH v Apozyt GmbH proceedings, pursuant to article 267º TFEU, was lodged on 20 October 2011.
The reference for a preliminary ruling has as its object the interpretation of article 3º, n.º 1, of Regulation (CE) n.º 726/2004, which establishes Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
The proposed question refers to the necessity of an authorization to develop an activity of preparation of Lucentis and Avastin medicine in syringes with the indicated dose to administer it. Both Lucentis and Avastin have been previously authorized as a medicinal product for human use, and licenses have been granted to Novartis and Roche Pharma AG respectively.
The Court of Justice issued its preliminary ruling, considering that an authorization would not be required for the activity described in this case, pursuant to article 3º, n.º 1, of Regulation (CE) n.º 726/2004, provided that the activity developed by the parties do not lead to any alteration in the medicinal product and is carried out exclusively based on individual prescriptions that require such operations.