How to obtain a wholesale dealer's licence

If you are importing products from within the European Economic Area (EEA) (the European Union plus Norway, Iceland and Liechtenstein) you will require a wholesale dealer's licence.

To obtain a wholesale dealer's licence (WL), you will need to meet approved standards of Good Distribution Practice (GDP) and submit a wholesale dealer's licence application form (1199Kb) to the MHRA. The application form should be completed clearly and one copy sent to the MHRA address on the form. It should be signed by the applicant and the relevant page(s) should be signed by the nominated Responsible Person (RP) .

Please see MHRA Guidance Note 6, 'Notes for applicants and holders of a wholesale dealer's licence'  for assistance in completing the application form.

Granting of the licence will be subject to findings upon inspection.

UK and European legislation and guidance about wholesale dealing is contained within the 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002'.

Inspections
All sites named on a wholesale dealer's licence are subject to regular inspections. Each site is inspected approximately every three years depending on the nature and scale of operation.This enables us to ensure that licence holders are complying with the conditions of their licence and that the site is operating in accordance with GDP.

Further guidance can be found in MHRA Guidance Note 6, 'Notes for applicants and holders of a wholesale dealer's licence'.

Responsible Persons
All holders of a wholesale dealer's licence for traditional herbal medicines for human use must have the services of a Responsible Person (RP) available to them. The RP will be responsible for safeguarding product users against potential hazards arising from poor distribution practices for example from the purchase of suspect products or poor storage. They will be required to ensure that the conditions of the wholesale dealer's licence are met and that the guidelines on GDP are complied with.

As with the QP, an RP does not have to be an employee of the registration holder but he or she must be accessible to them.

› More information on Responsible Persons

Further information will be added to this section as work on the introduction of the new scheme progresses.

Further information
For further information on the Traditional Herbal Medicines Registration Scheme, please see our 'Where to go for further advice' section.