How Much Will it Cost to Gain a WDA(H) aka Wholesale Dealers/Distribution Authorisation?

What are the costs associated with gaining and retaining your WDA?

A lot depends upon your business model, but your average pharmacy stock skimming models costs half for the initial inspection as a “normal” wholesaler, as long as they trade 15% or less of their turnover.

Small wholesalers trading in less than £35,000.00 per annum also benefit from the reduced inspection rate and licencing… but have limits as to profitability.

For a site selling General Sales List (GSL) products only, the inspection fee is half.

The new rates for GDP inspections are now £2662 and £1331 (GSL) + VAT, as of 01 Apr 2023.

What is normal, though? We see many different models, all with their own merits. At last count there were over 40+ types of different wholesaler models.

What type of business do you run, and is it successful? We are always interested to hear from new friends.

A full list of costs to attain a WDA and have the inspection are here;

https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences#fees-and-payment

But this is just the start.

You will need to temperature map any areas used for stock holding, or processing, including pharmaceutical fridges, quarantine and returns areas, and goods in/out areas.

Qualification of your new warehouse, software and GDP related kit?

Calibrated thermometers and data loggers can be used, or a continual monitoring system which records everything to your PC or a cloud solution.

You need Standard Operating Procedures which are tailored to your business, not generic or commercially sourced documents. These will be the backbone of your Quality Management System, but only a part of it.

Will you be transporting your own goods, or using a courier? You’ll need to verify or preferably validate your modes of delivery, or sign contracts with your customers and let them collect. This reduces your burden and puts the responsibility on the customer to ensure that their modes of transport are suitable and safe.

Suppliers and customers will need to be validated… checking bona fides is a critical part of the puzzle.

And there is more to follow…. training… pest control monitoring… more… more…

There is a lot of work involved in getting a WDA, and even more in retaining it… anyone who says “It’s easy” may not be telling you the whole truth.

If you set up correctly and do your daily, weekly and monthly tasks, it all slots into place, just like any process. Capture deficiencies, subject them to CAPA principles, and share learnings.

 

And remember, if in doubt, ask your inspector, or call us for a free five minute consult.

Welcome to a new Paradigm!