Published ·
Urban wastewater rules before the Court: what Opinion C-193/25 means for pharma logistics and supply
Advocate General Juliane Kokott proposes annulling Article 9(1)(a) and Annex III of Directive (EU) 2024/3019. No GDP rule changes today, but a major cost and supply-chain assumption is now open.
What the Advocate General proposed on 3 September 2026
In Case C-193/25 Advocate General Juliane Kokott proposes that the Court annul Article 9(1)(a) and Annex III of Directive (EU) 2024/3019. The provisions initially focus extended producer responsibility on medicines and cosmetics. This is an independent Opinion, not the Court's judgment, and the Court is not bound by it. The Article 8 obligation for quaternary treatment is not removed by the proposal.
Why evidence matters for the 80% cost allocation
Under Article 9, covered producers must finance at least 80% of quaternary-treatment costs. The Opinion challenges whether the evidence adequately supports concentrating that burden on two sectors. The German Environment Agency explains that the trigger is placing products on a Member State market, irrespective of the sales channel, making importer, distributor and contractual roles relevant.
What changes for warehousing, picking and GDP distribution - and what does not
The Opinion does not change GDP storage, qualification, documentation or transport requirements today. It may change the commercial assumptions used by manufacturers, importers, wholesalers and logistics providers. Scenario models should separate product portfolio, market-placer role, volume, fee design and contractual pass-through. Receipt, status control, FEFO, batch traceability, picking and qualified distribution remain operational priorities.
Modelling supply risk across the pharmaceutical chain
Regulatory product costs may affect purchase prices, sourcing, safety stock, assortment depth and the viability of low-volume or supply-critical medicines. GDP networks should therefore connect direct product cost, operational warehouse and distribution cost, and the risk of weaker availability or alternative sourcing. Environmental outcomes and security of supply belong in the same impact assessment.
Inter-Pharma turns regulation into workable logistics scenarios
Inter-Pharma supports cost and role mapping, procurement and inventory scenarios, warehouse capacity, WMS and picking design, GDP risk assessment, transport qualification and contingency supply. The goal is a controlled supply model that remains workable under either judicial outcome.
FAQ on C-193/25 and pharmaceutical logistics
Has the Court already annulled Article 9?
No. The Advocate General delivered her Opinion on 3 September 2026. The Court's judgment is still pending.
Does quaternary wastewater treatment disappear?
No. The proposal concerns producer funding under Article 9(1)(a) and Annex III, not the separate Article 8 treatment obligation.
Do GDP requirements change now?
No. Existing GDP duties remain. The immediate task is cost, contract and supply-scenario planning.