Do you need a Wholesale Dealer’s Licence (WDA) to conduct your business in the UK?  If so, our blog below provides an outline of where to start and how to apply to the Medicines and Healthcare Products Regulatory Agency (MHRA).

Persons operating from the UK require a Wholesale Dealer’s Licence (WDA) if, in the course of their business, they are engaged in:

  • Procuring, holding, supplying or selling medicinal products for human use sourced in the UK or another EEA Member State, to anyone other than members of the public;
  • Importing medicinal products from a non-EEA Member State for export to a non-EEA Member State;
  • Exporting medicinal products to a non-EEA Member State

Note: This includes virtual operations where no physical handling of the products takes place.

 

Where can I find detailed guidance on obligations and requirements?

The holder of a WDA must fulfil certain obligations and conditions, detailed here:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/717500/Guidance_Note_6_-_WDA_and_Brokers_-_19th_June_2018_Update.pdf

 

What personnel are required?

Directive 2001/83/EC requires that all licenced wholesale dealers should have at their disposal at least one person available as the Responsible Person (RP).

 

The application process and timeline

  • Apply using the MHRA Process Licencing Portal
  • Your application will be assessed by MHRA and should take 90 working days to process
  • The MHRA will only issue a Wholesale Dealer’s Licence when it is satisfied, following an inspection of the site(s), that the information contained in the application is accurate and in compliance with the requirements of the legislation.

 

What are the fees?

Full application fee: £1803 (reduced £902)

Standard inspection (per site): £1936 (reduced £968)

Annual service fee: £288 (reduced £172)

 

Reduced fees apply for wholesale distribution if:

  • you are applying for a wholesaler licence to sell general sale list medicines only
  • you are a registered pharmacy and the wholesale of medicines amounts to less than 15% of your total turnover in licenced medicinal products
  • you are not a registered pharmacy and you make less that £35,000 a year from licenced medicinal products

There are also fees for variations (standard and administrative).

 

If it is a Manufacturer’s Licence you require then take a look at my previous blog: https://fusion-pharma-limited.com/mhra-manufacturers-licence-mia/

 

Fusion Pharma can apply on your behalf through our approved access to the MHRA’s Process Licensing Portal.  If you would like to discuss how Fusion Pharma can support you with gaining a WDA, please email us at hello@fusion-parma-limited.com or phone us on +44 (0) 203 1379 799.

 

While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information.  Please refer to the relevant guidance for the latest information.