No “new placement on the market” as a result of carrying out the preparation of ready-to-use syringes based on individual prescriptions.
"41. When it prepares ready-to-use syringes in order to respond to orders placed by pharmacies in which patients have handed in prescriptions for such syringes, a company such as Apozyt does not use any of the biotechnological processes listed in point 1 of the Annex to Regulation No 726/2004; nor, moreover, does it supply anything to those pharmacies in advance, either directly or indirectly through wholesalers. Furthermore, it is apparent from the order for reference, and in particular from the wording of the question raised, first, that the Landgericht Hamburg proceeds on the basis that the composition of the medicinal product is not modified. Second, the content of the syringes that have been pre-filled in that way is administered to the patient by the prescribing doctor who has thus himself decided to treat his patient using such syringes.
42. In such circumstances, provided that the referring court does in fact find that the processes in question do not result in any modification of the medicinal product and that they are carried out solely on the basis of individual prescriptions making provision for them, there is no ground for considering that the activity thus carried out can be equated with a new placing on the market of a medicinal product included in point 1 of the Annex to Regulation No 726/2004; accordingly, the company concerned is, in that respect, not subject to the obligation to hold a marketing authorisation granted by the Community pursuant to Article 3 (1) of the regulation.
54. In view of all the foregoing considerations, the answer to the question referred is that 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 No 726/2004 but remain, in any event, subject to Directive 2001/83."
C-535/11 - ECLI:EU:C:2013:226