Human Medicines Order 2025: pharmacist authorisation of pharmacy technicians and UK health and safety implications for business and compliance

The Human Medicines Order 2025: pharmacist authorisation of pharmacy technicians and UK health and safety implications for business and compliance

What has changed

The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 introduces a new framework enabling pharmacists to authorise others, particularly pharmacy technicians, to perform tasks that would previously have required pharmacist supervision. It also allows pharmacy technicians to take primary responsibility for the preparation and assembly of medicinal products in hospital aseptic facilities. The change alters delegation, accountability and governance across pharmacy services in health and social care settings.

Why this matters for UK health and safety law

By formalising delegation arrangements, the update directly affects risk controls around aseptic preparation, patient safety and regulatory compliance. Organisations must ensure that duties are clearly assigned, that competent oversight exists, and that documentation accurately reflects who is authorised to perform each task. The update sits within the broader framework of UK health and safety law and HSE requirements for medicines handling, pharmacovigilance and staff competence.

Who is affected

Hospitals and hospital based pharmacy services, NHS trusts and other organisations running hospital aseptic units are impacted. Pharmacists who delegate tasks and pharmacy technicians who take primary responsibility must operate within approved competency frameworks and governance arrangements. Community and private providers with hospital aseptic facilities may also be affected where similar arrangements exist.

Key duties for employers and duty holders

• Review and update delegation policies to reflect new authorisation powers
• Establish clear competency criteria and an authorisation process for pharmacists delegating tasks to technicians
• Update standard operating procedures for aseptic preparation and assembly
• Carry out health and safety risk assessments for delegated tasks
• Maintain appropriate supervision, governance and audit trails
• Provide training and ongoing professional development for staff
• Keep records of authorisations and ensure management systems align with ISO 45001 where appropriate

Enforcement and sanctions

Compliance will continue to be under UK health and safety law with consequences for organisations that fail to manage risk or maintain competent staffing. The HSE will expect robust governance, clear delegation records and validated training as part of ongoing regulatory compliance.

Steps to achieve compliance

1. Map tasks that may be delegated to pharmacy technicians and confirm who can authorise them
2. Define competency standards and implement a formal authorisation process
3. Update risk assessments and SOPs for aseptic preparation and handling
4. Provide appropriate training and assess competence before authorisation
5. Review contractor and supplier controls and ensure governance documentation is complete
6. Align management systems with ISO 45001 where relevant and consider external support

A structured implementation approach, supported by a competent partner such as Competent Person support or ISO 45001 occupational health and safety management, can help ensure every step delivers sustained regulatory compliance and improved risk control.

Organisations should consider engaging with Synergos Consultancy for guidance on risk assessments and management system alignment as part of an evidence based approach to compliance.

In practice this means policies, procedures and governance should be updated, workers consulted, training refreshed, and management systems reviewed to reflect new delegation and accountability structures. Doing this now helps ensure patient safety and business resilience in the evolving landscape of UK health and safety law.

Effective implementation supports better governance, clearer accountability and enhanced risk control across hospital pharmacy services while aligning with HSE requirements and broader regulatory expectations.

The change represents a meaningful step in how healthcare organisations manage medicines handling and staff competency within UK health and safety law.

Timely action will enable organisations to demonstrate compliant, well governed and resilient operations as part of UK health and safety compliance obligations.

For more information and practical guidance on governing such changes, consider engaging with Synergos Consultancy.