Where the role comes from
A wholesale dealer’s licence issued under the Human Medicines Regulations 2012 requires the licence holder to have at their disposal the services of a Responsible Person. The RP is named on the licence itself, which means a change of RP is a licence variation and not an internal HR matter.
The substance of the role is set out in Chapter 2 of the EU GDP guidelines, which the UK continues to apply. MHRA Guidance Note 6 then adds the national expectations around eligibility, knowledge and the relationship between the RP and the licence holder.
The duties named in GDP Chapter 2
Chapter 2 lists the RP’s responsibilities directly. An inspector will expect to see evidence that each of these is being discharged, not simply that a person holds the title.
- Ensuring a quality management system is implemented and maintained.
- Focusing on the management of authorised activities and the accuracy and quality of records.
- Ensuring initial and continuing training programmes are implemented and maintained.
- Coordinating and promptly performing any recall operations.
- Ensuring relevant customer complaints are dealt with effectively.
- Ensuring suppliers and customers are approved.
- Approving any subcontracted activities which may impact GDP.
- Ensuring self-inspections are performed at appropriate regular intervals following a prearranged programme, and that necessary corrective measures are put in place.
- Keeping appropriate records of any delegated duties.
- Deciding on the final disposition of returned, rejected, recalled or falsified products.
- Approving any returns to saleable stock.
- Ensuring that any additional requirements imposed on certain products by national law are adhered to.
What can be delegated, and what that requires
Delegation is permitted, and Chapter 2 anticipates it by requiring the RP to keep records of delegated duties. What cannot be delegated is accountability: the RP remains answerable for the outcome even where another person performs the task.
The practical test inspectors apply is whether the delegation is documented, whether the delegate is trained and competent for that specific task, and whether the RP retains visibility of the outcome. A delegation that exists only as an informal understanding is usually treated as no delegation at all.
Decisions on final disposition of returned, rejected, recalled and falsified stock, and approval of returns to saleable stock, are the areas where inspectors most often expect the RP’s own judgement rather than a delegate’s.
Availability and the “at their disposal” test
The requirement is that the licence holder has the RP’s services at their disposal. In practice this means the RP must have enough time, authority and access to actually perform the duties for the site and the volume of activity concerned.
This is a recurring source of inspection findings for part-time and contract RPs. The question is not whether a name appears on the licence but whether that person can demonstrably reach the records, the stock and the decisions when needed.
Evidence an inspector will look for
Because the duties are broad, the evidence tends to be specific. A well-prepared RP can produce, without a long search: the current self-inspection programme and the last completed report, the training matrix and recent records, the approved supplier and customer lists with the basis for approval, the deviation and CAPA log, and records of RP decisions on returns and recalls.
The gap that causes most difficulty is not missing procedures but missing evidence that the procedures were followed on specific dates by specific people.
Common questions
- Can one person be the Responsible Person for more than one company?
- It is possible, but the licence holder must still be able to show the RP has sufficient time and authority for each site. MHRA scrutinises multi-site and multi-company RP arrangements closely, and the practical limit depends on the scale and risk of the activities rather than a fixed number.
- Does the RP have to be an employee?
- Not necessarily. Contract RPs are used across the sector. The licence holder must be able to demonstrate the contractual arrangement gives the RP the access and authority the role requires.
- What is the difference between an RP and an RPi?
- The RPi is a separate role introduced for Great Britain, concerned with importing medicines from countries on an approved country for import list. A site may need both, and the duties are not interchangeable.
- What happens if the RP leaves?
- Because the RP is named on the licence, a departure requires a variation. Licence holders are expected to have contingency arrangements so that wholesale activities are not conducted without an RP in place.