Previously, once inspected by a Competent Authority and found to be compliant to Good Distribution Practice (GDP) you would be issued with a Wholesale Dealer’s License (WDL). This has now been replaced by a Wholesale Distribution Authorisation (Human) (WDA(H)).
What’s the difference?
The WDL was a single document (license) issued by your Competent Authority if you were found to be GDP compliant at the time of your inspection.
The WDA(H) is a certificate of Good Distribution Practice (GDP) issued by your Competent Authority in the same way as the WDL, but if you are found to have non-conformities a statement of non-compliance may be entered onto the EudraGMDP website.
http://eudragmdp.ema.europa.eu/inspections/view/common/GDPHomePage.xhtml
What are the benefits?
You will now have access to the statements of non-compliance and make a risk based decision about the suitability/safety of your supply chain.
Does this affect your business at all?
Do you have any questions?
One of our RPs would be glad to have a chat you. Pharmacy Consulting can be contacted on 01252 302 342.