EU Pharmaceutical Reform: What the New Legislation Will Change

The European Union is completing the biggest overhaul of its medicines legislation in around two decades. The European Parliament and the Council reached political agreement on the reform in December 2025, and the adopted acts are expected to enter into force during 2026, with the new rules applying in stages from 2026 to 2028.

What the reform aims to do

• Make medicines more available and affordable across all EU member states, not just the largest markets.

• Strengthen the security of supply and give regulators more tools to prevent and manage shortages.

• Adjust incentives for innovation, including for new antimicrobials.

• Streamline regulatory procedures and reduce administrative burden.

Implementation

The European Medicines Agency has set up a dedicated governance structure, led by an oversight group, to manage implementation of the new pharmaceutical legislation.

Why it matters outside the EU

For UK businesses and clinics trading with Europe, EU rules shape what products are available, how they are labelled, and how supply obligations work. Changes to shortage-prevention duties may also affect how manufacturers allocate stock between markets.

What to do now

Keep an eye on the implementation timeline, especially if you supply or buy across the UK and EU border. Acorn Pharmaceuticals works with clinics in Germany, Italy and across Europe, and we follow these changes so our customers do not have to.