What is a Wholesale and Distribution License in pharma?
A Wholesale and Distribution License (commonly referred to as WDL) is a type of license used in the pharmaceutical industry. Although Wholesale Distribution License is the official name of the license, some refer to a WDL as a “GDP License”.
When do I need a Wholesale Distribution License?
You need a Wholesale Distribution License (WDL) 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 transport medicine without storing them (or outsourcing the storage) for more than 72 hours do not fall under the GDP regulatory requirements.
You are not eligible for a Wholesale Distribution License or a Good Distribution Practice (GDP) certificate.
How do I get a Wholesale Distribution License?
Unlike ISO, you cannot “request” a Wholesale Distribution License / GDP license. 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:
- Germany: follow this link.
- Portugal: follow this link.
- France: follow this link.
For an extensive list of all the competent authorities in the European Union, go to the website of the European Medicines Agency.
After the 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 License (WDL) 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.