The EU Pharmaceutical Package will reshape major parts of EU pharmaceutical law. For parallel imports, however, the central message is continuity. The current draft Directive no longer contains the proposed rule that would have allowed Member States to require new outer packaging for parallel imported medicines. The CJEU’s established case law on repackaging therefore remains the key framework.
This article provides a practical overview of the expected impact of the EU Pharmaceutical Package on parallel imports of medicines.
Parallel imports in the EU pharmaceutical market
Parallel imports of medicines have long been a recurring issue in the EU internal market. Parallel importers use differences in price, supply and reimbursement conditions between Member States. They buy medicines that have lawfully entered the market in one Member State and sell them in another Member State, without a commercial mandate from the marketing authorisation holder or the trademark owner.
Parallel trade is an expression of the free movement of goods and can strengthen price competition. However, medicines are among the most heavily regulated products on the market. Patient safety, reliable product information, security of supply and trademark rights all play an important role. Parallel imports therefore sit at the intersection of internal market law, pharmaceutical regulation and intellectual property law.
The EU Pharmaceutical Package represents the most significant reform of EU pharmaceutical law in more than twenty years. It aims to improve access to medicines, strengthen security of supply, modernise regulatory procedures and maintain incentives for innovation. However, it does not create a new regime for parallel imports. It may affect the regulatory and commercial environment, but it does not reset the existing rules.
No new general rule on reboxing
The most important point is what the current draft Directive no longer contains. At an earlier stage, the European Parliament proposed a new Article 67(7)(a) in the draft Directive. This provision would have allowed Member States, for reasons of patient safety, to require that parallel imported medicines are repackaged in new outer packaging. Such a rule could have given parallel importers a broader regulatory basis for re-boxing and would have replaced the current case-by-case assessment under trademark law. It would also have overturned the CJEU’s recent case law on the interpretation of the Falsified Medicines Directive (Directive 2011/62/EU) in the context of parallel imports, which confirmed that a national rule requiring re-boxing of a medicine by the parallel importer is contrary to EU law (CJEU, judgments of 17 November 2022, C-147/20, Novartis Pharma; C-204/20, Bayer Intellectual Property; C-224/20, Merck Sharp & Dohme).
The current compromise text no longer contains Article 67(7)(a) and the proposed new rule does not appear to have moved elsewhere. It can be concluded that the EU legislature decided not to introduce a general rule allowing Member States to require new outer packaging for parallel imported medicines.
This keeps the existing legal balance in place as the proposed new rule would have provided parallel importers with a general justification for re-boxing. Now trademark owners and marketing authorisation holders can continue to rely on the CJEU’s established case law, which allows a trademark owner to object to the marketing of a repackaged medicine unless the parallel importer meets strict conditions. The key question remains whether the repackaging is objectively necessary to market the medicine in the import Member State (CJEU, judgment of 11 July 1996, joined cases C-427/93, C-429/93 and C-436/93, Bristol-Myers Squibb; CJEU, judgment of 26 April 2007, C-348/04, Boehringer Ingelheim). In particular, the falsified medicines rules do not automatically justify new outer packaging simply because the importer needs to open the original packaging and replace the anti-tampering device. The importer must show a real obstacle to market access. General assumptions about resistance by patients, pharmacists or wholesalers do not suffice (CJEU, judgments of 17 November 2022, C-147/20, Novartis Pharma; C-204/20, Bayer Intellectual Property; C-224/20, Merck Sharp & Dohme).
The existing parallel import framework remains in force
The EU Pharmaceutical Package does not introduce a groundbreaking new system for parallel import authorisations. It largely preserves the existing logic. A simplified route remains possible where the imported medicine and the reference medicine in the import Member State are sufficiently close from a therapeutic and regulatory perspective. Art. 162(3a) of the draft Directive codifies the CJEU’s existing case law on the substantive requirements for parallel import authorisation.
In practical terms, the parallel importer must still show that the imported medicine and the reference medicine have a common origin and do not differ in a therapeutically relevant way (Art. 162(3a) of the draft Directive). Member States may set additional requirements for demonstrating product identity. This follows the CJEU’s long-standing case law, under which authorities cannot require a full new marketing authorisation procedure where they can rely on an existing assessment and public health does not require a new full review (CJEU, judgment of 20 May 1976, C-104/75, De Peijper).
The draft Directive also allows a Member State to refuse a parallel import where the import would circumvent the mutual recognition procedure (Art. 162(3a) subpara. 3). However, the draft Directive does not define under what conditions such “circumvention” is to be assumed, leaving room for interpretation. The practical impact of this rule will depend on how authorities apply it. A broad interpretation could limit the availability of the simplified import route, while a narrow reading would preserve the existing balance between market access and regulatory coordination.
Shortage rules may affect trade flows
The EU Pharmaceutical Package places stronger emphasis on security of supply. The reform introduces new planning, reporting and coordination tools to prevent and manage shortages. It also gives exporting Member States more visibility over intended parallel exports in shortage related situations. This matters because parallel trade depends on differences between Member States, including price levels, available volumes, reimbursement systems and distribution structures. If new shortage mechanisms reduce supply differences or allow authorities to intervene more quickly, they may also reduce some incentives for parallel trade.
Art. 120(1a) of the draft Regulation provides that an exporting Member State may require information about an intended parallel export, including the name and authorisation number of the product concerned, active substance, pharmaceutical form, strength, pack size and the planned export volume. If the export risks creating or worsening a shortage, the Member State may adopt proportionate measures to prevent or mitigate that risk. The European Medicines Agency (EMA) must be informed of any measures taken. This does not give Member States a free hand to block parallel trade. The free movement of goods remains a core principle of EU law. Any restriction must pursue a public health objective and remain proportionate.
Electronic package leaflets may reduce packaging interventions
The EU Pharmaceutical Package also promotes the broader use of electronic package leaflets. Under Art. 63(3) of the draft Directive, Member States may provide that the package leaflet must be made available in electronic form only. A paper version must then be provided free of charge only upon patient request, and the marketing authorisation holder must ensure its availability. Patients must still have access to the necessary product information, and that information must remain available in the language required for the relevant market.
For parallel imports, this may reduce some practical reasons for opening the outer packaging. Today, parallel importers often need to adapt the package leaflet to the language and regulatory requirements of the Member State of importation. This may require them to open the outer packaging and replace the leaflet. If the required leaflet is available electronically, this step may become unnecessary in certain cases. This could also reduce trademark-relevant repackaging events.
However, electronic package leaflets will not remove all packaging and labelling issues. The parallel importer must still ensure that the electronic package leaflet is available in the language of the import Member State and that patients can access it (Art. 162(4) in conjunction with Art. 63(3) of the draft Directive). It is also likely, although not explicitly stated in Art. 162(4), that the parallel importer remains responsible for ensuring that a paper version is available upon request. The parallel importer must translate the labelling into the language of the import Member State (Art. 162(4) in conjunction with Art. 74 of the draft Directive) and is also likely to remain subject to national labelling requirements under Art. 72(1) of the draft Directive. Parallel importers must therefore ensure that patients and healthcare professionals can identify and use the medicine safely in the import Member State.
A recent Opinion of Advocate General Szpunar illustrates this point. The case concerns a parallel imported medicine where the outer packaging and package leaflet are available in the required language, but strict language requirements for the immediate packaging could prevent the import. The Advocate General considered that EU labelling rules apply to parallel imports, but that authorities need flexibility where strict language requirements would prevent imports without improving patient protection (Opinion of Advocate General Szpunar of 11 June 2026, Case C-354/25, Waisrinter, paras. 38 et seq.).
It remains to be seen whether the CJEU will follow this approach. In any event, the issue shows that electronic product information will not eliminate the need to balance patient safety, language requirements and the free movement of goods. For parallel imports, electronic package leaflets may reduce some practical triggers for opening the packaging. They will not, however, replace the need to comply with labelling requirements of the import country.
Generic and biosimilar competition may reduce margins
The EU Pharmaceutical Package also affects the broader competitive environment. The current compromise text maintains an eight-year regulatory data protection period but shortens the baseline market protection period to one year. It also expands the Bolar exemption, allowing generic and biosimilar companies to prepare more effectively for market entry. The shorter protection periods and extended Bolar exemption mean that generics will enter the market faster.
This may indirectly reduce the commercial space for parallel imports. Parallel imports often become attractive where originator medicines remain protected and price differences between Member States create a sufficient margin. Earlier generic or biosimilar competition may reduce that margin. Generics are typically cheaper than the reference medicine and therefore represent a direct competitor to parallel imports, potentially reducing their economic attractiveness.
Key takeaways
The EU Pharmaceutical Package does not reset the rules for parallel imports. The proposed Article 67(7)(a), which would have introduced the possibility for Member States to require re-boxing of parallel imported medicines, is no longer included in the current text.
The CJEU’s established repackaging case law therefore remains intact and will control the admissibility of parallel imports. In particular, parallel importers will still need to show that repackaging is objectively necessary. Trademark owners can continue to challenge re-boxing where re-labelling would suffice to give the product effective market access.
At the same time, the EU Pharmaceutical Package could change the framework conditions for parallel trade in several respects: First, through a more coordinated Union-wide shortage and supply system, which could significantly restrict parallel trade in shortage or crisis situations. Second, through the electronic package leaflet, which may reduce some occasions for repackaging. Third, product identity and anti-circumvention rules (Art. 162(3a) of the draft Directive) may also shape parallel import procedures. Finally, changes to regulatory protection and the Bolar exemption may increase competitive pressure for parallel imports from generics and biosimilars.
