WDA(H) Consultant

What a WDA(H) covers

A Wholesale Dealer Authorisation (Human) is the licence the MHRA issues to a UK company that wholesales medicines for human use. It is granted under Part 9 of the Human Medicines Regulations 2012, and it carries a standing obligation to work to Good Distribution Practice for as long as you hold it.

The authorisation names a company, not a person. That distinction matters more than it first appears: accountability for GDP compliance sits with the licence holder and cannot be passed to a contractor, a consultant or the Responsible Person. Tasks can be delegated. Responsibility cannot. If you want the detail, I have written it up in what a WDA(H) licence holder actually is.

A WDA(H) is also not a Marketing Authorisation. The two cover different activities and different duties, and companies that hold both sometimes discover the overlap only during an inspection. The difference is set out in WDA(H) versus MAH.

How I can help

New applications

Most first applications are delayed by the same things: documentation that does not yet describe what the company actually does, premises that have not been assessed against GDP, or Responsible Person arrangements that are not settled. I work through those before submission rather than after a request for information. The route itself is described step by step in how to apply for a WDA(H) in the UK.

Variations

Changing your Responsible Person, adding a site, taking on a new product category or altering your authorised activities should each trigger a variation assessment. The GDP impact is worth assessing before the submission goes in, because the assessment is what the MHRA will want to see. Responsible Person changes need particular care; I have set out why in when UK wholesale dealers need to notify the MHRA.

Inspection readiness

A GDP inspection tests whether your quality system does in practice what your documents claim. Gap assessment ahead of time turns that from a discovery exercise into a rehearsal. Where findings have already been issued, I help build remediation that closes them properly rather than restating the finding back to the inspector.

Ongoing compliance

A licence is not a one-off event. Supplier and customer qualification, temperature control, deviation handling, self-inspection and Responsible Person oversight all have to keep running. Where you need a named Responsible Person or RPi, or periodic GDP auditing, those can run alongside this.

WDA services at a glance

• WDA(H) application support
• Pre-application gap assessments
• Site preparation and compliance planning
• MHRA inspection preparation
• Post-inspection remediation
• WDA variation applications
• Compliance monitoring programmes
• Authorised person arrangements

Common questions

What does WDA(H) stand for?

Wholesale Dealer Authorisation (Human). It is the licence the MHRA issues to a UK company that wholesales medicines for human use, and it is granted under Part 9 of the Human Medicines Regulations 2012.

Who is the WDA(H) licence holder?

The licence holder is the company named on the authorisation, not an individual. Accountability for compliance with Good Distribution Practice sits with that company, and it cannot be transferred to a contractor or to the Responsible Person.

Is the licence holder the same as the Responsible Person?

No. The licence holder is the authorised company. The Responsible Person is a named individual who must be available to the company and who carries specific duties under GDP. A company needs both.

When does a change need a WDA(H) variation?

Changes to your Responsible Person, your sites, the categories of product you handle, or your authorised activities should all be assessed for a variation. Assess the GDP impact of the change before you submit, not afterwards.

Do I need a WDA(H) as well as a Marketing Authorisation?

They cover different activities. A Marketing Authorisation permits a product to be placed on the UK market. A WDA(H) permits the wholesale distribution of medicines. Many companies hold both, and the two sets of duties overlap but are not interchangeable.

What happens at an MHRA GDP inspection?

An inspector reviews your quality system, premises, records and the Responsible Person arrangements against GDP, then issues findings graded by severity. Preparation is a matter of evidencing what your system already does, which is why gap assessment before the inspection is worthwhile.

Official sources

This page summarises published guidance. Always work from the primary source:

• MHRA — apply for manufacturer or wholesaler of medicines licences
• Human Medicines Regulations 2012, Part 9
• MHRA — good manufacturing practice and good distribution practice
• EU Guidelines on Good Distribution Practice (2013/C 343/01)

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