Reform of the EU pharmaceutical legislation
Major reforms are being introduced to the EU’s medicines legislation, with the new legislation expected to come into force in the coming months. First proposed by the European Commission in 2023, these reforms represent the most significant change to EU pharmaceutical legislation in over 20 years.
This page is for companies and organisations that develop, make, or supply medicines. The page will also contain information for healthcare professionals and users of human medicines. It outlines the new EU pharmaceutical legislation, how the HPRA is preparing for the changes, and how to stay up to date with developments.
What does the new legislation aim to achieve?
The new legislation aims to create a modern, resilient, and patient-centred regulatory framework for medicines in the European Union. It seeks to ensure that people across the EU have access to safe, effective, and affordable medicines. This new framework will also support innovation and strengthen Europe's competitiveness as a location for developing and manufacturing medicines.
Key aims of the legislation include:
- Improving access to medicines for patients across Europe
- Encouraging the development of innovative medicines and treatments
- Supporting the development and availability of medicines for rare diseases and children
- Strengthening security of supply and helping to address medicine shortages
- Reducing unnecessary burden while maintaining high standards
- Enhancing the environmental sustainability of medicines
- Tackling antimicrobial resistance
- Supporting scientific and technological advances, including new therapies
The legislation also aims to strengthen collaboration across the European medicines regulatory network. It will help the EU respond effectively to public health challenges through stronger cooperation and coordinated action.
More information on the background and aims of the legislation can be found on the European Commission's website.
Current status and next steps
The European Parliament and the Council of the European Union reached agreement on the revised legislation in December 2025. The Council subsequently adopted the legislation on 28 September 2026 and it will now need to be adopted by the European Parliament. The legislation will then enter into force following publication in the EU’s Official Journal. The new requirements will be applied on a phased basis over the following two years.
How is the HPRA preparing for implementation?
The HPRA is working closely with medicines regulators across Europe, including the European Medicines Agency (EMA), to prepare for the new pharmaceutical legislation. This work is helping regulators to understand the changes that will be required and to plan for their implementation in a coordinated way. Further details of this work can be found on the EMA's website.
At national level, we are working closely with the Department of Health and relevant stakeholders to prepare for the changes that will be needed. This includes changes to national legislation, procedures, and guidance.
Within the HPRA, a dedicated project team has been established to lead preparations for implementation. The team is reviewing the new legislation and assessing how it will affect the HPRA's processes, systems, and services. The team is also assessing the impact on stakeholders and will continue to engage with affected groups.
Staying updated
As implementation planning progresses, the HPRA will provide updates and guidance to help stakeholders understand and prepare for changes.
To stay up to date with information and resources that will help you understand and prepare for the new legislation, you can register for the HPRA's 'My Alerts' service.
If you have any queries, please contact us using our online contact form. When completing the form, under ‘Category’ select ‘Medicines for human use’. Under ‘Topic’, select ‘EU pharmaceutical legislation reform’.