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What is a Wholesale and Distribution Authorization (WDA) in pharma?

WDA, or Wholesale Distribution Authorization, is crucial in the pharmaceutical industry. It's required for storing medicinal products for over 72 hours. Learn how to obtain it and navigate post-Brexit regulations for exporting to the EU.

A Wholesale and Distribution Authorization (commonly referred to as WDA) is a type of license used in the pharmaceutical industry. Although Wholesale Distribution Authorization is the official name of the license, some refer to a WDL, WDA or a “GDP License”.

When do I need a Wholesale Distribution Authorization (WDA)?

You need a Wholesale Distribution Authorization (WDA) if you meet the following two conditions;

  • You are a distributor / logistical company situated in the European Union.

  • You store medicinal products for a period longer than 72 hours.

Distributors without (outsourced) storage

Organizations that do not store medicines for more than 72 hours do not need a WDA.

Organizations that transport medicines do not need a WDA.

If you do not need a WDA, you cannot get a WDA.

How do I get a Wholesale Distribution Authorization (WDA)?

Unlike ISO, you cannot “request” a Wholesale Distribution Authorization / GDP certificate. There is no company you can invite to perform an inspection against the GDP’s and then certify you.

If you are distributing (and storing medicine for longer than 72 hours) you must register your legal entity with your local regulatory authority.

In the Netherlands you must apply your legal entity to Farmatec, which is the licensing authority in the Netherlands for pharmaceutical licenses.

If you are based in other European countries you must apply to your local regulatory authority, a few examples are provided below:

For an extensive list of all the competent authorities in the European Union, go to the website of the European Medicines Agency.

After the wholesale license application

If you application has been accepted, an inspection of your site will be scheduled. The national regulatory authority will use a risk-based approach when planning inspections. Critical sites will be inspected first. E.g.; distributors involved in the supply chain of Covid vaccines will be prioritized over manufacturers of other products.

You must ensure you are properly prepared for the regulatory inspection. Verify that you have implemented all the EU Good Distribution Practice (GDP) requirements as well as any local regulatory requirements.

For companies outside the European Economic Area (EEA)

The Wholesale Distribution Authorization (WDA) and the associated GDP certificate do not apply to you. You may refer to other regulatory frameworks that detail requirements similar to the GDP requirements;

  • WHO Technical Report Series, No. 937, 2006

  • U.S. FDA 21CFR11 – Subpart H – Holding and Distribution

Can I export medicine to the EU as an MHRA licensed wholesale distribution site?

Prior to Brexit, you could easily send products to continental EU-member states. Post-Brexit this has become more complicated. It is preferred to establish a legal entity in an EU member state that imports from the United Kingdom. Please note that this legal entity should have a Manufacturing and Import Authorization if it imports the product.