Medicinal products regulatory consolidation in UK health and safety law: implications for business

Medicinal products regulatory consolidation in UK health and safety law: implications for business

What has changed in UK health and safety law

The new Regulations consolidate the UK law relating to medicinal products for human use. The change creates a single framework that standardises definitions and duties across manufacturing, distribution, licensing and marketing of medicines. It is intended to improve clarity for organisations operating in the medicines supply chain and align legal expectations with UK health and safety law.

Who is affected

The update affects organisations involved with medicinal products for human use, including manufacturers, wholesalers and distributors, pharmacies and clinics, NHS bodies and care homes, importers and exporters, and retailers. It also affects procurement teams, regulatory/compliance leads and those responsible for supplier management and recall procedures.

Key duties for employers and other duty holders

• Ensure awareness of the consolidated regime and its implications for governance and risk management.
• Review supplier and contractor arrangements for medicines handling and distribution.
• Update risk assessments related to storage, handling and transport of medicinal products.
• Verify that appropriate licences are in place for manufacturing or distribution activities and that competent persons are engaged where required.
• Revise policies and procedures to reflect the consolidated regime and align with regulatory expectations.
• Strengthen pharmacovigilance and product recall processes where applicable.
• Provide staff training and ensure ongoing competence through coaching and specialist support.
• Consider systematic management system improvements such as ISO 45001 to integrate health and safety with medicines compliance.

To support implementation and ongoing compliance, reference and guidance from Synergos can help establish governance and risk controls. For example, Competent Person support can assist with skilled advice, while ISO 45001 occupational health and safety management provides a framework for systematic control of workplace risk and legal compliance, and health and safety risk assessments support hazard identification and risk control.

Enforcement and sanctions

Regulators responsible for medicines legislation, supported by the HSE where relevant, may review organisations’ compliance with the consolidated regime. Non-compliance with duties, deficiencies in governance or failure to implement appropriate control measures could expose organisations to enforcement actions, penalties or corrective action requests.

Steps to achieve compliance

• Map current practices to the consolidated regime and identify gaps in governance, risk management and operations.
• Update health and safety policies, standard operating procedures and risk assessments to reflect the new framework.
• Review supplier and contractor arrangements, ensuring appropriate due diligence, contracts and recalls procedures are in place.
• Update training programmes and ensure staff understand their responsibilities under the consolidated regime.
• Align management systems with the new requirements, for example by integrating ISO 45001 with medicines compliance.
• Engage workers in consultation and seek competent advice where required to avoid non compliance.

The changes emphasise governance, competence and continuous monitoring of medicines handling alongside general health and safety risk control. Synergos can support organisations with a structured approach to compliance and risk management, including training and ongoing advisory services.

To help you navigate the transition, consider a practical plan: assign accountability, refresh risk assessments, review supplier controls and schedule targeted training for relevant staff. These steps will strengthen your organisation’s readiness for the updated UK health and safety law framework governing medicinal products for human use.

By aligning with a robust health and safety management approach, including consideration of ISO 45001, organisations can meet the legal duties set by the consolidated regime and protect patients, staff and stakeholders.