UK health and safety law update: commencement of the Human Medicines Order 2025 enabling pharmacist authorisation and pharmacy technician supervision
What has changed
The Health and Medicines Order 2025 contains provisions for authorisation by pharmacists and supervision by pharmacy technicians for human medicines. The instrument now provides for the commencement of the Order in so far as it is not yet in force, bringing these provisions into operation under a 2026 Commencement Order. The change affects pharmacy settings, including community and hospital pharmacies, and other healthcare organisations that administer medicines.
Why this matters
This change alters who can perform certain authorisation tasks and how supervision of pharmacy technicians is structured. It has implications for governance, risk management and regulatory compliance within UK health and safety law. Organisations should plan to review roles, competencies and documentation to ensure alignment with the new authorisation framework while maintaining HSE requirements and safe operation of medicines handling.
Effective governance and robust risk controls remain essential. Consider integrating the change with an existing health and safety management system such as ISO 45001 to support systematic control of workplace risk and legal compliance. Health and safety risk assessments guidance can help translate the update into practical actions. Synergos Consultancy can provide guidance on management system alignment and competent person support if needed.
What organisations should do next
- Confirm the commencement date for the enabling provisions and monitor for any further regulatory guidance.
- Review existing policies, procedures and risk assessments relating to medicines authorisation and supervision.
- Update role descriptions, training materials and competence records for pharmacists and pharmacy technicians.
- Revise supplier and contractor arrangements where third party governance interfaces are involved in medicines administration.
- Integrate the new requirements with your health and safety management system, ensuring governance, documentation and monitoring meet HSE expectations.
- Engage with workers and their representatives to capture insights and address concerns, including any changes to supervision patterns and safety controls.
For ongoing support and a structured path to compliance, consider working with a specialist in management systems such as ISO 45001 health and safety management or health and safety risk assessments. Synergos Consultancy can assist with planning, competency mapping and training where appropriate.
The changes reinforce the requirements of UK health and safety law and emphasise the importance of robust governance and competent oversight for medicines governance. Timely action will support smoother implementation and ongoing regulatory compliance.
In summary, organisations should approach this as a practical governance and risk management update that touches on people, processes and systems to ensure safe medicines handling under UK health and safety law.