Responsible Person Services in the UK

Ongoing oversight and regulatory compliance for UK wholesale distribution licence holders.

This page focuses on RP services in the UK. For our full quality and compliance methodology, including QMS design, GDP auditing, inspection management, and licensing support, see Quality & Compliance. For an overview of all named compliance roles we provide (RP, QP, QPPV, and others), see Legal Representation.

UK Regulatory Landscape

Under UK law, every wholesale distribution licence (WDA) must have a Responsible Person (RP) who ensures that all medicinal products are stored, handled, and distributed in compliance with Good Distribution Practice (GDP). The RP carries personal legal responsibility for the wholesaler’s operations, including maintaining quality systems, approving documentation, and overseeing deviations, complaints, and temperature-controlled storage.

RP requirements are set out under Regulation 45 of the Human Medicines Regulations 2012 (SI 2012/1916). RPs must be named on the WDA before assuming responsibility for any operations. Post-Brexit, the RP also plays a critical role in verifying EU-certified imports under the listed-country route and ensuring compliance with the Windsor Framework and other UK-specific import regulations acting as a Responsible Person for import (RPi). The RPi role is distinct from the RP role, though the same individual can hold both. Both must be named on the WDA.

What We Handle Locally

Our UK based RPs and RPis are named on clients’ WDAs or provide RP oversight where the company does not employ their own RP. This is not advisory work: our RPs take full legal responsibility for compliance in all aspects of the distribution operation.

  • RP oversight and GDP management:
    Regular review of SOPs, quality system documentation, training records, storage conditions, and distribution processes.
  • Import verification and compliance:
    Verification of EU QP-certified imports from listed countries and management of non-listed country imports under UK GDP standards.
  • Deviation, complaint, and incident management:
    Review, approval, and oversight of temperature excursions, supply chain deviations, and product complaints.
  • Internal GDP audits:
    Proactive assessment of compliance gaps and mitigation before MHRA inspections.
  • Regulatory correspondence:
    Liaison with the MHRA , submission of WDA variation applications, and guidance on any regulatory updates affecting the RP role.

UK Operations

Our RPs operate across Great Britain and Northern Ireland, ensuring compliance under UK-specific GDP regulations:

Jurisdiction RP/RPi Arrangements
Great Britain RPs and RPis named on WDA licences; full oversight of GDP operations; MHRA as competent authority
Northern Ireland Operates under Windsor Framework; RPs and RPis ensure compliance with EU GDP recognition for listed-country imports; specific labelling and supply chain requirements apply

Key UK Regulations

The regulatory framework for RP services in the UK.

  • Human Medicines Regulations 2012 (SI 2012/1916) – RP responsibilities under WDA (https://www.legislation.gov.uk/uksi/2012/1916/contents/made)
  • UK GDP Guide (The Orange Guide, MHRA) – compliance framework for wholesalers
  • MHRA Guidance Notes for WDA holders – RP duties, import verification, and variation applications
  • Windsor Framework Implementation Guidance (2024/2025) – UK and Northern Ireland import and labelling requirements
  • RP Code of Practice – legal responsibilities and standards for ongoing oversight

Key Irish Regulations

  • European Communities (Good Manufacturing Practice and Good Distribution Practice for Medicinal Products for Human Use) Regulations 2007 (S.I. No. 786 of 2007) – RP responsibilities under WDA
  • Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use

Need a Responsible Person?

Tell us about your products, distribution arrangements, and requirements, and we will outline how our RP services can ensure compliance and provide legal oversight.

Contact us

UK-Specific FAQs

For general questions about RP responsibilities, batch certification processes, and GDP compliance, see the FAQs on Quality & Compliance.

Do I need a UK RP if I import EU products?

You need an RP for any WDA. If you import from listed countries (currently all EU/EEA states), you additionally need an RPi named on the licence to verify that each batch has been QP-certified in the listed country before it enters the UK supply chain. The RP and RPi can be the same person but they are distinct roles with different legal responsibilities under Regulations 45 and 45A.

Can you provide an RP for my WDA quickly?

Timelines depend on portfolio size and complexity. Simple arrangements can often be onboarded within weeks. Contact us with the specifics and we will give you a realistic timeline.

Do you cover temperature-sensitive and high-risk products?

Yes. Our RP oversight includes cold chain management, controlled storage, and specialised product handling.

Can your RP oversee clinical trial or investigational products?

No. UK legislation requires investigational medicinal products (IMPs) to be imported under a Manufacturing and Importation Authorisation (MIA), with oversight by a named Qualified Person (QP). IMPs cannot be imported under a WDA. The RP/RPi role covers commercially authorised medicinal products only. For IMP import and QP services, see our Ireland office which holds an MIA for batch release and QP certification.

What is the difference between an RP and an RPi?

The Responsible Person (RP) is responsible for GDP compliance across the entire wholesale distribution operation: storage, handling, documentation, deviations, complaints, and quality systems. The Responsible Person for Import (RPi) has a specific additional responsibility: verifying that medicinal products imported from listed countries have been QP-certified before release to the UK supply chain. Both roles must be named on the WDA. The same individual can hold both, but the legal responsibilities are distinct.