The Court of Justice of the European Union (CJEU) stated in its judgment dated 11 April 2013 that re-packaging medicinal products from an injection bottle to a smaller dose, ready-to-use syringe, does not, under certain conditions, require a marketing authorization.

Novartis filed a suit against Apozyt claiming that they should have a marketing authorization for the repackaging of Novartis’ drug Lucentis. Novartis distributes the drug in injection bottles intended for the administration of a single dose, for which only one quarter of the medicinal liquid is used. Apozyt on the other hand prepares ready-to-use syringes containing only the small dose of Lucentis necessary for a single injection. The syringes are prepared according to the dose prescribed by a doctor. Hence none of the drug goes to waste, and the final price of the drug is considerably lower than the price of Novartis’ injection bottle.

According to the CJEU’s judgment the repackaging of medicinal products does not require a marketing authorization under Article 3(1) of Regulation No 726/2004, provided that

  1. the re-packaging does not result in a modification of the medicinal product concerned; and
  2. the repackaging is carried out solely on the basis of individual prescriptions calling for processes of such kind.

In conclusion, if a medicinal product has been granted a marketing authorization according to Directive 2001/83, repackaging of such medicinal product is regarded as a process involving dividing up or changing of packaging or presentation within the meaning of Article 40(2) of the Directive, and therefore does not require an additional marketing authorization.