Responsible Person Services

What the Responsible Person does

Every company holding a Wholesale Dealer Authorisation (Human) must have a named Responsible Person recorded on that authorisation. The role is required under the Human Medicines Regulations 2012, and the duties attached to it are set out in Chapter 2 of the EU GDP Guidelines.

In practice the RP is the person who has to be able to say, with evidence, that distribution activities are running to GDP: that procedures are approved and followed, that quality events are investigated and closed, that suppliers and customers are qualified, and that products are stored and shipped within their conditions.

One point is worth stating plainly, because it is often misunderstood. The RP is a named individual with personal duties. The licence holder is the authorised company, and accountability for GDP compliance stays with it. Appointing an RP, internal or contract, does not move that accountability. I have written about the distinction in what a WDA(H) licence holder actually is.

RP or RPi: which do you need?

These are two different roles and the difference decides what cover you need.

A company that both wholesales and imports may need both covered. One person can hold both roles where they have the knowledge and the time for each, but that should be assessed rather than assumed. The background is in what a Responsible Person is and what the role requires.

How I work as your RP

I act as named RP or RPi on a permanent, part-time or interim basis. The role is an active one: reviewing and approving procedures, overseeing deviations and CAPA, running or commissioning self-inspection, and being the point of contact when the MHRA inspects.

Interim cover is the request I see most often, and usually for the same reason: an RP has resigned and the authorisation cannot simply sit without one. A change of RP should be assessed for a variation and notified, which is covered in when UK wholesale dealers need to notify the MHRA.

Where the quality system underneath the role needs work first, that is usually a QMS or GDP consulting piece, and can run alongside RP cover rather than instead of it.

RP/RPi services

• Named RP for WDA(H) holders
• Named RPi for importers
• Ongoing compliance oversight
• Quality event review and approval
• SOP and procedure approval
• MHRA inspection liaison
• Regulatory submission support
• Part-time or interim RP arrangements

Common questions

What is a Responsible Person (RP) in GDP?

The Responsible Person is the named individual accountable for ensuring that a wholesale dealer’s activities meet Good Distribution Practice. The role is required under the Human Medicines Regulations 2012 and its duties are set out in the EU GDP Guidelines. The RP must have adequate knowledge and experience of pharmaceutical quality systems.

Do I need a named Responsible Person?

Yes. Any company holding a Wholesale Dealer Authorisation (Human) must have a named Responsible Person recorded on the authorisation. The RP carries personal duties under GDP, while accountability for compliance remains with the licence holder company.

What is the difference between an RP and an RPi?

An RP oversees wholesale distribution activities under a WDA(H). An RPi, Responsible Person (Import), covers the additional duties that apply when medicines are imported into Great Britain from a listed country. A company that both wholesales and imports may need both roles covered.

Can the same person be RP and RPi?

One person can hold both roles where they have the knowledge and experience for each and can give both the time they require. The two sets of duties are distinct, so the arrangement should be assessed rather than assumed.

Can the Responsible Person role be outsourced?

Yes. Many companies appoint a contract RP, either permanently or to cover a gap. The RP must be genuinely available to the company and must have the authority to act. Outsourcing the role does not move accountability away from the licence holder.

What happens if our Responsible Person leaves?

A change of Responsible Person should be assessed for a WDA(H) variation and notified to the MHRA. Leaving the role vacant puts the authorisation at risk, which is why interim cover is often arranged while a permanent appointment is made.

Official sources

• Human Medicines Regulations 2012, Part 9
• EU Guidelines on Good Distribution Practice (2013/C 343/01)
• MHRA — good manufacturing practice and good distribution practice

This page is general guidance, not regulatory advice. For advice on your specific situation, get in touch.