The MHRA Responsible Person (RP): Duties, Eligibility and Appointment for WDA(H) Holders

A company applying for a wholesale dealer’s licence, or replacing a departing RP, has to name a person the MHRA will accept and who can do the job in practice. The MHRA Responsible Person is not a title on the licence. It is a role with legal functions, and an inspector can test whether the person named carries them out.

This guide sets out what the RP must do, who can take the role, what stays with the licence holder, and the records that show the RP is active.

What is the MHRA Responsible Person?

The MHRA Responsible Person (RP) is the person named on a wholesale dealer’s licence, WDA(H), who ensures that the conditions of the licence are met and that the quality of the medicines handled is maintained. Regulation 45 of the Human Medicines Regulations 2012 sets the requirement. The MHRA explains how it applies in section 9 of Guidance Note 6 for applicants and holders of a wholesale dealer’s licence.

The RP works under Good Distribution Practice (GDP). In practice the RP is the licence holder’s quality lead for wholesale distribution: the person who makes sure suppliers and customers are approved, decides what happens to returned or recalled stock, and makes sure the quality system works.

Who must appoint an RP, and when the MHRA must be told

Every holder of a WDA(H) must have at its disposal at least one RP, available at all times, whose knowledge and experience the MHRA considers adequate. The RP is named in the licence application, so the person must be in place before the company applies. Guidance Note 6 asks new applicants to be inspection ready at the point of application, with detailed training records and job descriptions, “especially that of the Responsible Person”. For the wider steps, see applying for a WDA licence.

The RP should be resident in the UK, and proof of identity and address is required as part of the application.

A change of RP is a change to the named persons on the licence. The MHRA classes this as a standard variation, made through the MHRA Process Licensing Portal. Variations should take 30 working days, or 90 if an inspection is needed. The licence holder must not let anyone act as RP who has not been named or notified to the MHRA, so the change should be planned before the current RP leaves.

Responsible Person duties under GDP

Guidance Note 6 lists the RP’s responsibilities, which follow chapter 2.2 of the GDP guidelines. The RP is responsible for:

• ensuring that a quality management system is implemented and maintained
• focusing on the management of authorised activities and the accuracy and quality of records
• ensuring that initial and continuous training programmes are in place
• coordinating and promptly performing any recall operations
• ensuring that relevant customer complaints are dealt with effectively
• ensuring that suppliers and customers are approved
• approving any subcontracted activities that may affect GDP
• ensuring that self-inspections are carried out at regular intervals to a set programme, with corrective measures put in place
• keeping 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 national requirements for certain products are met

Supplier approval, subcontracting and returns all involve third parties such as hauliers and storage providers. See how RPs work with logistics partners.

The RP should fulfil these responsibilities personally and be continuously contactable. Tasks can be delegated to trained staff, but responsibility stays with the RP. Guidance Note 6 expects written reports showing that delegated actions were done to procedure, and “demonstrable oversight” of them.

What the RP is accountable for and what stays with the WDA(H) holder

The RP is accountable for the GDP functions above. The licence holder keeps its own obligations under the licence, including providing the staff, premises, equipment and facilities needed to maintain the quality of the medicines, and telling the MHRA about any change to the RP.

The licence holder must also make the role workable. Guidance Note 6 says the RP should:

• have a clear reporting line to the licence holder
• have the defined authority, resources and responsibility needed to fulfil the duties
• have access to all areas, sites, stores, staff and records relating to the licensed activities
• show regular review and monitoring of those areas, sites and staff
• keep records of how the RP responsibilities were carried out

The licence holder should have a process for receiving the RP’s advice and recording the action taken. If the two cannot resolve a disagreement, the MHRA should be consulted. A joint referral is preferred, but either party may approach the MHRA, and an RP who has difficulty carrying out the statutory responsibilities can consult it in strict confidence.

In the MHRA Inspectorate’s words, “Respective responsibilities between the RP and the Licence Holder should be clearly defined and understood” (MHRA Inspectorate blog, July 2018). For the obligations that continue after approval, see compliance responsibilities after the licence is granted.

Who can be an RP: knowledge, experience and seniority

There is no recognised qualification or central register for RPs, unlike the Qualified Person under a manufacturing licence. The licence holder chooses and assesses the person, and the MHRA can refuse or remove an RP who does not meet its expectations.

Guidance Note 6 sets these expectations:

• Practical experience. At least one year’s practical experience of the activities authorised on the licence, such as procuring, holding, supplying or exporting.
• Technical knowledge. How to qualify suppliers and customers, identify medicinal products, understand storage conditions and temperature control, and transport medicines.
• Quality system experience. At least one year’s experience in maintaining a quality management system appropriate to the licence.
• Training. Evidence of completed GDP training, and regular training to maintain competence, with records.
• Personal knowledge. The relevant parts of the Human Medicines Regulations 2012, the legislation of the market the company supplies, the GDP guidelines, the licence conditions, the products traded and the categories of people they may be supplied to. The RP should also have access to pharmaceutical and technical advice when needed.

Seniority also matters. The MHRA’s eight areas for RP suitability include “sufficient seniority and influence” within the organisation (MHRA Inspectorate blog, July 2018). An RP who cannot stop a supply or reject a supplier will struggle to show control.

Guidance Note 6 also points to the Responsible Person Gold Standard, an industry competency framework approved in April 2014. It says licence holders should use it to select and induct an RP, and prospective RPs to plan their learning.

If the RP cannot show the required experience and knowledge, or is not carrying out the duties adequately, the MHRA may vary the licence to remove the RP. This can extend to other licences that name the same RP.

The records an inspector will ask for to show the RP is active

GDP inspectors can interview key personnel named on licences and examine any records relating to storage and distribution. These records should be ready before the inspection:

• The job description, signed, stating the RP’s responsibilities and authority and where the role sits in the organisation chart
• The contract, for a contract RP, stating responsibilities, duties, authority and time on site
• The RP’s training record: induction to the business, GDP training and ongoing development
• Training records for all staff. The MHRA says records “should cover all staff; this includes the RP and Licence Holder” (MHRA Inspectorate blog, July 2018). See GDP training for your team.
• Delegation records: who does which task on the RP’s behalf, and the written reports the RP receives
• Approval records for suppliers, customers, subcontracted activities and returns to saleable stock
• Self-inspection reports with corrective actions and their close-out
• Management review records showing the RP’s reports to the licence holder and the action that followed

Where more than one RP is named, the quality system should make clear which RP is primarily accountable for each responsibility, by function or by site. A nominated deputy can support the RP across several sites, but the term “Deputy RP” is not legally recognised. Only the RPs named on the licence carry the legal responsibility.

In-house or contract RP: how to evaluate the options

The RP does not have to be an employee of the licence holder. A licence holder can engage a contract RP or appoint an employee, often the quality lead. Neither option is better in itself. The question is whether the person can carry out the functions for the licence holder’s operation.

For either option, ask:

• Availability. Can the RP be reached during a recall or an out-of-hours alarm? Who supports the RP when they are off site?
• Knowledge of the operation. Does the RP know the company’s products, sites, suppliers, customers and transport routes?
• Time. Is the time on site written down, and does it match the volume and risk of the company’s activities?
• Authority. Can the RP stop a supply, reject a supplier or quarantine stock without waiting for approval?
• Reporting line. Does the RP report directly to the licence holder or managing director?

For a contract RP, add these checks from the MHRA’s expectations for contract RPs (August 2018):

• The contract is with the individual RP named on the licence, not the consultancy.
• It covers the scope of the role, each party’s duties and responsibilities, and the RP’s availability, and it is reviewed regularly.
• The MHRA expects a contract RP to cover every function at every site on each licence they hold, and it can see how many licences name them. Ask how many other licences the person holds.
• The licence holder reviews the contract RP’s performance regularly.
• The RP’s training record is available to the licence holder and the inspector.

RP, RPi and EU Responsible Person: how the roles differ

RP. The person named under regulation 45 for a WDA(H), covering the GDP functions above.

RPi. A licence holder in Great Britain that imports licensed medicines from an approved country for import, such as an EU or EEA country, needs a Responsible Person (Import) under regulation 45AA. The RPi carries out the RP functions, unless an RP already does so for the licence, and must confirm that each imported batch has been certified as provided for in Article 51 of Directive 2001/83/EC, or an equivalent procedure in the approved country. The RPi must be on the MHRA’s register, and the licence holder must apply to vary the licence before changing the RPi. For more, see the Responsible Person (Import) role.

EU Responsible Person. A WDA(H) covers wholesale dealing under UK law. Wholesale distribution in an EU member state needs an authorisation from that state, with an RP who meets its rules. The EU GDP guidelines say a degree in pharmacy is “desirable”, and some member states require one. In Northern Ireland, the authorisations the RP checks against also include Article 126a authorisations (Guidance Note 6, section 9.3).

The UK Responsible Person for medical devices is a different role, for manufacturers based outside the UK, and is not covered here.

Signs that an RP is in name only

Read against the Guidance Note 6 expectations above, these signs show the role exists on paper only:

• The RP cannot describe the products, suppliers or customers when asked.
• Supplier and customer approvals are signed by someone else with no documented delegation, or signed by the RP in batches long after trading started.
• The RP receives no written reports from staff who carry out delegated tasks.
• Self-inspections are overdue, or their corrective actions have no owner.
• The contracted time on site is far below what the activity needs, or the visit records do not match it.
• Management review minutes do not show the RP’s reports or any decision taken on them.
• The RP has had no training on the business since appointment.

Each of these is a gap a licence holder can close before an inspector finds it. Treat them like audit findings: assign an owner, set a date and record the fix. See managing GDP audit findings and CAPA.

Preparing the RP role for inspection

Before an inspection, confirm that:

1. The RP named on the licence is the person doing the job, and any change has gone through the MHRA as a variation.
2. The job description, and the contract for a contract RP, state responsibilities, authority, reporting line and time on site.
3. The RP’s training record shows GDP training, induction to the business and recent development.
4. Delegated tasks are listed, and the RP receives written reports on them.
5. Supplier, customer, subcontractor and returns approvals are signed by the RP or under a documented delegation.
6. Self-inspections are up to date, and management reviews record the RP’s input and the action taken.

Inglasia’s Responsible Person support for WDA holders covers RP role definition, governance set-up and training. If you need support defining the RP role or preparing your RP for inspection, contact us to discuss how we can help.