On 28 September 2026 the Council of the European Union adopted the pharma package, the most comprehensive reform of European pharmaceutical law in over 20 years. It replaces the existing directive and regulation and brings them together in a new legal framework.
If you work in pharmaceutical wholesale, you are not the main audience of this reform. Most of the new obligations apply to marketing authorisation holders and manufacturers. It is still worth a look. The reform rests on availability, early warning and documented supply chains, and in practice the information behind all three comes together at the wholesaler. This article sets out what is settled, what is still open and what you can already prepare.
Where the procedure stands
Council and European Parliament reached a political agreement in December 2025, and the compromise texts were published in March 2026. The Council adopted the package on 28 September 2026. Formal steps remain before the texts are published in the Official Journal of the European Union and enter into force.
Transition periods apply once the package is in force. Analyses of the compromise texts so far put the period for most provisions at around two years. The new rules are therefore expected to take practical effect from 2028. The exact date depends on publication in the Official Journal.
The pharma package is not the same as the Critical Medicines Act, which we cover in a German-language article. Both aim at security of supply, but they are separate pieces of legislation. The pharma package covers authorisation and market law as a whole. The Critical Medicines Act focuses on critical medicines and public procurement.
What the package regulates
Protection periods and incentives. New medicines will receive eight years of data protection and one year of market protection. Under certain conditions, market protection is extended. This matters mainly to manufacturers and only indirectly to wholesale, for example through the date from which generics become available.
Security of supply. Marketing authorisation holders are to report supply interruptions and withdrawals earlier and keep plans to prevent shortages. This also applies to medicines that are already authorised. Further legal acts and guidelines will define what these plans look like in detail.
Access and availability. Under certain conditions, member states are to be able to require authorisation holders to supply their products in sufficient quantities.
Other topics. The package also contains incentives against antimicrobial resistance. They are not the focus for wholesale inventory management.
What wholesale will actually notice
The pharma package does not require any new software function from wholesalers. Its effect is indirect. If authorisation holders have to report and prevent shortages earlier, they are likely to ask distribution partners more often about stock and sourcing routes. A wholesaler who can answer such questions quickly and reliably is the more dependable partner.
Good Distribution Practice already requires that origin, supplier status and batch movements are traceable. If you keep this data connected, you are prepared for additional requests, wherever they come from.
Three questions you can check today
Can you show the path of a batch end to end? Check whether the data from supplier through goods receipt to customer sits in one place or is spread across purchasing, warehouse and spreadsheets. The more systems involved, the longer a reliable answer takes.
Is supplier data current and usable? Qualification status, origin and alternative sources should be available without anyone having to dig out documents first. Our German-language article on supplier and customer qualification under GDP describes what a robust dossier looks like.
Is stock per product and batch always up to date? When a partner asks about short-term availability, you need an answer you can rely on.
Conclusion
The pharma package has been adopted but is not yet in force, and its obligations apply mainly to authorisation holders. Wholesalers do not have to act today. The direction is clear, though. You should be able to show supply chains, stock and supplier data as a whole on request. Businesses that already keep this data in one place are well prepared for 2028.
Sources: EU Law Live, report on the Council’s adoption of the pharma package on 28 September 2026; Pharma Focus Europe, report on the final pharma package; Pharmazeutische Zeitung, coverage of the agreement and the rules against shortages; Crowell, analysis of the procedure and deadlines.