The European Court of Justice (ECJ) received a fresh request for a preliminary ruling regarding parallel trade in medicines from the highest administrative court in Germany, the Bundesverwaltungsgericht (BVerwG) (see, attached notice taken from the Official Journal of the European Union of 8 September 2025 regarding case C-354/25, Waisrinter, and see, English translation of order of BVerwG of 20 March 2025). The case, remarkably referred to by a fictitious name, concerns the importation into Germany of an unnamed medicine indicated for the treatment of advanced prostatic cancer. The product consists of two prefilled syringes whose content, one a liquid and one in powder form, have to be mixed before use. The syringes each come in a thermoformed packaging tray which is sealed with a film. The two packaging trays are in turn contained in an outer carton and are intended for single use only.

The medicines imported from Italy, Poland, and Romania benefit from a marketing authorisation in their originating Member State but do not satisfy the labelling requirements of German law and of Articles 54, 55(3), and 63 (1) of Directive 2001/83/EC on the Community Code relating to medicinal products for human use (the Community Code). These Community Code provisions concern respectively the medicine’s outer packaging, its immediate packaging, and language requirements (in this case the use of readily understandable German).

The questions now before the ECJ are as follows:

• Do the labelling requirements apply to this situation of parallel importation? The question as such is remarkable given the need for all medicinal products, locally authorised or otherwise, to satisfy public health and safety standards, including sector-specific labelling requirements. Additionally, the ECJ has already confirmed as much in a case regarding the application of labelling and package leaflet requirements to the parallel importation of veterinary medicinal products (case C-114/15, Audace, ECLI:EU:C:2016:813, at § 56).
• Is the parallel importer able to rely on one of the exceptions to the labelling and package leaflet requirements provided for by Article 63(3) of the Community Code? The exception at issue concerns medicinal products “not intended to be delivered directly to the patient”. However, the BVerwG is considering three possible meanings for this phrase: (i) medicinal products subject to medical prescription; (ii) medicinal products not handed over to the patient; or (iii) medicinal products not intended to be administered by the patient. The concrete scope of the exception may vary greatly, depending on the meaning which the ECJ will attribute to Article 63(3). Given the need for continued regulation of parallel imports for public health reasons, the “medical prescription” approach would seem unlikely.
• Does Article 63(3) of the Community Code have direct effect which would permit the parallel importer to argue the applicability of the exception against the German State?
• Are the labelling requirements of the Community Code in conformity with the free movement of goods principles enshrined in Articles 34 and 36 of the Treaty on the Functioning of the European Union (TFEU)? For the BVerwG, the application of the labelling requirements amounts in this case to a measure having equivalent effect to quantitative restrictions on imports. This is because opening the thermoformed packaging in order to relabel the syringes pursuant to the labelling requirements would significantly reduce the shelf life of the product and is therefore not possible. As a practical matter, the labelling requirements would thus preclude the parallel importation of the product, but the BVerwG appears to suggest correctly that such an impediment would be justified under Article 36 of the TFEU for public health reasons.

The ECJ is expected to deliver a judgment in the second half of 2026.