GDP guide · Sources checked October 2026
Wholesale dealer licence records (WDA(H)) and the Responsible Person
Wholesale dealer licence requirements in the UK are that the holder of a WDA(H) complies with regulations 43 to 45AB of the Human Medicines Regulations 2012, which include Good Distribution Practice, and always has at least one Responsible Person at their disposal. Wholesale distribution authorisation requirements, including the Responsible Person’s duties, are set out in MHRA Guidance Note 6.
Last updated .
Wholesale distribution authorisation requirements
What the licence holder must do
Guidance Note 6 summarises the conditions. Read the regulations and the note itself for the full wording.
On smaller screens, scroll the table sideways to see every column.
| Requirement | What MHRA Guidance Note 6 says | Source |
|---|---|---|
| Comply with the regulations and GDP | The holder must comply with the conditions in regulations 43 to 45AB of the Human Medicines Regulations 2012, which include compliance with Good Distribution Practice | MHRA Guidance Note 6, section 8, checked October 2026 |
| Staff, premises and equipment | Provide and maintain the staff, premises, equipment and facilities needed to keep product quality and ensure proper distribution | MHRA Guidance Note 6, Appendix 2, checked October 2026 |
| Tell the MHRA about changes | Inform the licensing authority of any proposed structural alteration to, or discontinued use of, licensed premises, and of any change to the Responsible Person | MHRA Guidance Note 6, Appendix 2, checked October 2026 |
| Supplier checks | Verify that a wholesale dealer supplying product complies with GDP, or that a manufacturer or importer supplying it holds a manufacturing authorisation | MHRA Guidance Note 6, Appendix 2, checked October 2026 |
| Supply records | When supplying a person who may lawfully sell by retail, enclose a document showing the date of supply, product name and form, quantity and the licence holder’s name and address, and keep a record for a minimum of five years | MHRA Guidance Note 6, Appendix 2, checked October 2026 |
| Qualifying for the licence | To qualify for a wholesale distribution licence you must comply with good distribution practice and pass regular GDP inspections of your site | GOV.UK: apply for manufacturer or wholesaler of medicines licences, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; your Responsible Person and the MHRA decide what applies to your licence.
Responsible person GDP requirements
The Responsible Person: duties and who they must be
Only the Responsible Person or persons named on the licence carry legal responsibility, and they remain responsible for duties they delegate.
On smaller screens, scroll the table sideways to see every column.
| Point | What MHRA Guidance Note 6 says | Source |
|---|---|---|
| At the licence holder’s disposal | Regulation 45 requires every licensed wholesale dealer to have at least one Responsible Person available, with appropriate competence, experience, and knowledge of and training in GDP | MHRA Guidance Note 6, section 9.1, checked October 2026 |
| Duties | Including: a quality management system implemented and maintained; accuracy and quality of records; training programmes; recalls; customer complaints; approving suppliers and customers and subcontracted activities; self-inspections; deciding the disposition of returned, rejected, recalled or falsified product | MHRA Guidance Note 6, section 9.3, checked October 2026 |
| Availability | Fulfils the duties personally, is continuously contactable and is resident in the UK. A non-employee RP needs a written contract setting out responsibilities, authority and time on site | MHRA Guidance Note 6, sections 9.4 and 9.6, checked October 2026 |
| Experience | At least one year’s practical experience of the activities on the licence, and at least one year’s experience maintaining an appropriate quality management system | MHRA Guidance Note 6, sections 9.8 and 9.9, checked October 2026 |
| Delegation and records | The RP receives written reports that delegated actions were done to SOPs and GDP, keeps records of how they discharge their responsibilities, and maintains their own GDP training with records | MHRA Guidance Note 6, sections 9.7 and 9.10, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; your Responsible Person and the MHRA decide what applies to your licence.
WDA(H) record-keeping: a practical list
Records that show the licence is being run properly
A practical reading of the sources above, not a legal test. Your Responsible Person decides what applies to your licence.
The MHRA’s 2016 deficiency data includes findings about an RP with insufficient knowledge of the activities, no formal RP training record, and a site that wholesaled product while not named on the licence (MHRA GDP deficiency data 2016, checked October 2026). For how inspections run, read the GDP inspection checklist.
- The licence and its annexes, and the date and content of every variation notified to the MHRA.
- A named-person record: who is the Responsible Person, any contract with a non-employee RP, and written reports on delegated duties.
- The Responsible Person’s own GDP training record (training records are covered here).
- Supplier and customer qualification records, with the authorisation checked and the date rechecked.
- Supply records for retail customers, kept for at least five years.
- Self-inspection reports and CAPA (deviation and CAPA records).
GDP record tracking is not available yet
Soteriaa is building GDP record tracking; join the waitlist. It is not available yet, and it will not replace the Responsible Person or approve any record. Join the GDP waitlist to hear when it opens.
FAQ
Common questions
What is a WDA(H)?
A wholesale distribution authorisation for human medicines, also called a wholesale dealer’s licence, issued by the MHRA. Licence holders must comply with Good Distribution Practice and the conditions in the Human Medicines Regulations 2012.
Who can be the Responsible Person?
MHRA Guidance Note 6 sets out the competence, experience and availability expected, and the MHRA can refuse or remove an RP who cannot demonstrate them. The RP does not have to be an employee, but must be continuously contactable.
Which records does a wholesale dealer’s licence require?
Guidance Note 6 specifically requires a record of supplies to retail customers, kept for at least five years, and GDP requires transaction records, procedures and training records. See the GDP documentation requirements guide for the detail.
Join the GDP waitlist
Leave your email and we will tell you when GDP record tracking for wholesale dealers opens. Nothing is on sale yet.