What is a Responsible Person? UK GDP Requirements Explained

What is a Responsible Person?

The Responsible Person is a key role required by the Human Medicines Regulations 2012 (Regulation 45). The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices.

According to the MHRA Inspectorate, the RP must ensure that wholesale distribution activities comply with GDP requirements at all times. This is not merely an administrative role – the RP has genuine responsibility for quality and compliance.

Who Can Be a Responsible Person?

To be named as an RP on a WDA(H), a person must have:

• Adequate knowledge of pharmaceutical quality systems and GDP requirements
• Sufficient experience in pharmaceutical distribution operations
• Appropriate training in GDP and related regulatory requirements
• Understanding of the specific products and activities covered by the authorisation

Key Responsibilities of the RP

The RP's responsibilities extend across all aspects of GDP compliance:

• Quality System Oversight – ensuring the QMS is implemented and maintained
• Batch Release – for importers, ensuring products meet UK-specific requirements
• Deviation Review – reviewing and approving investigations into quality events
• Supplier Qualification – ensuring suppliers are appropriately qualified
• Training – ensuring staff are adequately trained
• Self-Inspection – ensuring regular self-inspections are conducted
• MHRA Liaison – acting as primary contact for regulatory inspections
• Documentation – ensuring all GDP-required records are complete and accurate

What is a Responsible Person for Import (RPi)?

The Responsible Person for Import (RPi) is a specific role for companies importing medicinal products into the UK. Following Brexit and the Windsor Framework, RPi requirements have become increasingly important.

From 1 January 2025, under the new MHRA guidance following the Windsor Framework, importers must ensure that products imported under the RPi process are compliant with UK-specific requirements, including appropriate labelling with 'UK Only'.

Legal Requirements

Under Regulation 45 of the Human Medicines Regulations 2012:

• The holder of a WDA must ensure the availability
• The of a Responsible Person name of the RP must be notified to the MHRA
• Any change to the RP must be notified to the MHRA in advance
• The RP must have adequate authority to perform their duties

Common Challenges

Many companies face challenges with the RP role:

• Availability – ensuring continuous oversight (RPs cannot be a name on a licence without active involvement)
• Time Commitment – RPs must dedicate sufficient time to their duties
• Authority – RPs must have genuine authority to stop non-compliant activities
• Competency – demonstrating ongoing competency through training
• Multi-site – managing RP duties across multiple locations

Outsourcing the RP Role

Many companies, especially smaller wholesalers or those new to distribution, choose to use a contract RP service. This can provide:

• Access to experienced professionals without full-time employment costs
• Flexibility during growth or transition periods
• Independent perspective on compliance
• Support during MHRA inspections

When using a contract RP, a Quality Agreement must be in place defining responsibilities, and the company must still ensure adequate oversight and resources.