- within Insolvency/Bankruptcy/Re-Structuring and Environment topic(s)
On 8 September 2025, the Court of Justice of the European Union (CJEU) received a preliminary request from the Bundesverwaltungsgericht, the German Federal Administrative Court BVerwG, referring a series of questions seeking interpretation on the applicability of certain rules to parallel trade of medicines, including whether German language and packaging requirements are proportionate or compatible with EU law. The request follows an order for a preliminary reference made by the BVerwG in March 2025. Notably, the request does not disclose the identity of the parallel importer, the manufacturer of the medicinal product, or the name of the product itself.
Background
The case concerns a medicinal product that is used in the treatment of advanced prostate cancer. The product comprises two prefilled syringes, one in liquid form and the other in powder form, both to be mixed together prior to administration. The syringes are individually sealed in a thermoformed tray, and are packaged together in a single-use outer carton.
In 2009, the parallel importer applied for a parallel import authorisation for the medicinal product, to be imported from Italy to Germany (where the medicinal product had already been granted in 2019 by the Federal Institute for Drugs and Medical Devices (FDMD)). The parallel importer sought to import the same product into Germany from Romania and Poland, and in 2014, applied to renew the authorisation. The FDMD granted the renewal on 8 September 2014.
The decision was contested by the holder of the German marketing authorisation, which claimed that the decision to renew the authorisation was unlawful on the basis that the product did not comply with German labelling requirements under the German Medicinal Products Act, which serves to transpose Articles 54, 55(3), and 63(1) of Directive 2001/83/EC (the "Directive") into national law. These provisions relate to the labelling of outer and immediate packaging of the medicine, as well as the requirement that all information be presented in "easily comprehensible German".
Relabelling the product to meet the requirements necessarily would involve opening the sealed thermoformed trays which, according to the Higher Administrative Court, would significantly impair the product's shelf life. As a result, the parallel importer argued that, in such circumstances, it would be justified for the parallel importer not to label the immediate container with particulars in German, in the interest of free movement of goods.
Preliminary request – questions before the CJEU
The proceedings were stayed and the BVerwG made a referral to the CJEU for a preliminary ruling. The BVerwG has sought clarification from CJEU on four points:
- Do the labelling requirements under the Directive apply to parallel-imported medicines in these particular circumstances?
The BVerwG cited kolpharma, noting that parallel import authorisations must be granted if the competent authorities of the Member State of importation confirms that the product shares the same formulation, active ingredient, and therapeutic effect as the reference product, and poses no concerns regarding quality, efficacy, or safety, even if the medicinal product is not identical in all respects. The BVewrG noted that while the CJEU has not yet ruled on whether labelling requirements must be assessed in such cases, the CJEU previously upheld strict labelling rules (which are no longer in force) for veterinary medicines (Audace). The BVerwG considered that the same approach should apply to human medicines.
2. Could the parallel importers rely on the exemption in Article 63(3) of the Directive which permits the waiving of labelling requirements if the medicinal product is not intended to be delivered directly to the patient?
The BVerwG reasoned that the Directive was insufficiently clear on how this criterion was to be interpreted and has requested clarification on three possible meanings:
- medicinal products subject to medical prescription;
- medicinal products not handed over to the patient; or
- medicinal products not intended to be administered by the patient.
3. Does the exemption within Article 63(3) of the Directive have direct effect, such that the parallel importers can rely on it before the German courts against the defendant Federal Republic of Germany which has not transposed that provision into national law or has not transposed it fully?
The CJEU established in Van Duyn v Home Office, that an EU directive only has direct effect if its provisions are clear, precise, and unconditional, and if the Member State has failed to transpose it within the prescribed timeframe. The BVerwG could not say with certainty whether Article 63(3) of the Directive is unconditional as far as its subject matter is concerned, or whether it gives the Member States the discretion to provide for a corresponding derogation. If it is the latter, the parallel importer would not be able to rely on the exemption set out in Article 63(3). The ambiguity surrounding the interpretation of the Article 63(3) exemption highlights the need for clearer legislative drafting.
4. Do Articles 34 and 36 TFEU, which protect the free movement of goods, preclude national or EU rules requiring specific labelling on the immediate packaging of parallel-imported medicines in the language of the importing Member State, where such relabelling would significantly impair the product's shelf life?
The finding by the Higher Administrative Court (which is binding on the BVerwG) that opening the thermoformed trays to relabel the syringes in line with the labelling requirements would significantly compromise the product's shelf life, making such relabelling unfeasible, effectively prevents the parallel import of the medicinal product from Italy, Poland, and Romania, into Germany. The BVerwG could not answer with sufficient clarity, whether such a restriction on the free movement of goods is justified under Article 36 of the TFEU on grounds of the protection of health and life of humans.
Comment
The CJEU's decision, which is expected to be delivered in 2026, may have significant implications for parallel trade of certain medicines in the EU, where compliance with national packaging and labelling requirements could compromise product effectiveness and safety, such as shelf life or sterility.
The referral raises important questions as regards the balance between national discretion and the EU's commitment to the free movement of goods. If relabelling poses risk to sterility or shelf life, waiving labelling requirements may not only be disproportionate but could potentially undermine patient safety.
The CJEU's ruling should be closely monitored, as a finding by the CJEU that national labelling requirements are disproportionate or incompatible with EU law would reduce regulatory barriers for parallel importers.
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