Referral C-371/26 (Janssen Biotech and Others, 20 Apr 2026)

Must the exception provided for in Article 5(2)(a)(i) and (ii) of Regulation (EC) No 469/2009, 1 as amended by Regulation (EU) 2019/933, be interpreted as meaning that it does not cover the making of a product – or a medicinal product containing that product – for the purpose of storing it in the Member State of making for an indefinite period and without any restriction, in order to place that product potentially on the market of one or more third countries in the future?

Must the expression ‘any related act that is strictly necessary … for the actual export’ in Article 5(2)(a)(ii) of Regulation (EC) No 469/2009, as amended by Regulation (EU) 2019/933, be interpreted as not covering the storage of a product – or a medicinal product containing that product – in the Member State of making, where the export itself does not take place immediately following the making of that product but is deferred to a separate and future point in time, for example because placing that product on the market in the third country of export first requires the expiry of intellectual property rights and/or depends on the issue of a marketing authorisation, or the equivalent of such authorisation, in the third country of export?

Must Article 5(2)(a)(i) and (ii) of Regulation (EC) No 469/2009, as amended by Regulation (EU) 2019/933, read in conjunction with Article 5(2)(b), (4), (5)(e) and (7) of that [first] regulation, be interpreted as meaning that a maker cannot rely on the exemption in Article 5(2)(a)(i) and (ii) if, at the time of the notification referred to in Article 5(2)(b), the maker has not (yet) obtained a marketing authorisation, or the equivalent of such authorisation, in the intended third country of export?

Must Article 5(2)(a)(i) and (ii) of Regulation (EC) No 469/2009, as amended by Regulation (EU) 2019/933, read in conjunction with Article 5(2)(b), (5)(e) and (7) of that [first] regulation, be interpreted as meaning that a maker cannot rely on the exception in Article 5(2)(a)(i) and (ii) if, at the time of making, the maker cannot place the product – or a medicinal product containing that product – on the market of the intended third country of export without infringing intellectual property rights in that third country of export?