If you manage a pharma trademark portfolio in-house, you already know the ECJ’s “BMS” criteria: repackaging is only lawful if objectively necessary, and you must be notified in advance. That case-law duty isn’t going away.
What’s new — and not yet on most radars — is Article 162 of the EU Pharma Package Directive, confirmed in the Council’s final compromise text (COREPER I, 6 March 2026). It introduces a separate statutory notification duty: a wholesale distributor who intends to distribute a product sourced from another Member State must notify both the marketing authorisation holder and the competent authority of the destination Member State — independent of, and in addition to, the trademark-law notice you’re used to receiving.
Two practical implications for your monitoring setup:
Two notification channels, not one. The Article 162 notification goes to your regulatory/MA team as much as to trademark counsel. If those two functions aren’t talking to each other, you may be missing half the picture on incoming parallel trade.
Fewer repackaging triggers ahead. Article 63 confirms Member States may permit electronic-only package leaflets, with a paper copy available only on patient request. Replacing the printed leaflet has long been one of the standard justifications for repackaging under trademark exhaustion. As electronic leaflets become more common, that justification — and with it, some of the situations where parallel importers can rely on exhaustion at all — may simply disappear in more cases.
Where things actually stand: this is the Council’s confirmed compromise text, not yet binding law. Formal adoption by Parliament and Council is expected in Q3/Q4 2026, followed by Official Journal publication and a roughly two-year transition period. No further substantive changes are expected to the text — but nothing is legally binding yet.
For in-house teams, that’s exactly the right window: enough certainty to prepare, before the compliance deadline is on top of you. Worth checking now whether your regulatory and trademark functions are set up to catch both notification streams once this applies.
Happy to talk through what this could mean for your specific portfolio.