07711 781764   dave@paradigmshiftconsulting.co.uk

What is a Wholesale Dealer/Distribution Authorisation AKA WDA (H)?

What is a Wholesale Dealer/Distribution Authorisation AKA WDA (H)?

Posted by
| Comments Off

An MHRA (other competent authorities are available!) Wholesale Distribution Authorisation (for medicines for human use) aka WDA(H) is the revised name for the MHRA “wholesale dealers licence” which is the licence issued by the MHRA (Medicines and Healthcare Products Regulatory Agency) to wholesalers.

If we don’t seem to be able to make up our mind re what it is called, the public domain has a number of different descriptions for a WDA(H), so we like to list them all!

Most frequently we still hear “WDL” and “Wholesale Dealer Licence.”

That said, throughout Europe all countries and competent authorities refer to this licence to trade pharmaceuticals a Wholesale Distribution Authorisation for Medicines for Human Use.

The previous “version,” the Wholesale Licence (WL), allowed the licencee to trade in medicines for human use, and specifically in Pharmacy (P), Prescription Only Medicines (POM), Traditional Herbal Medicine Products (THMP) and General Sales List (GSL) medicines.

This MHRA wholesale dealer licence was often, and mistakenly, referred to as a “WDL,” which in reality only allowed you to trade in GSL (General Sales List) items.

The format of the new MHRA WDA(H) is somewhat different from the old licences, and in some cases this has proved confusing.

It has, however, become the recognised licence throughout Europe, and once all wholesale dealer licence/wholesale distribution authorisation/wholesale dealer authorisation holders are updated to the new WDA(H) and have had a follow up inspection, it will be visible on the EudraGMDP site here;

http://eudragmdp.ema.europa.eu/

This website is becoming one of the most useful resources for wholesalers, or pharmacies buying goods, as it will allow you to check GDP compliance or non-compliance certificates for every wholesaler in Europe, all in one place for the first time.

Need more help on using the site to check bona fides? View our blog post on using EudraGMDP which includes tips from the Data Processing Manager at the MHRA, Sean Kaiser.

Need help understanding the new wholesale dealer licence/wholesale distribution authorisation/wholesale dealer authorisation, or need help applying for one?

Our consultants offer services at very reasonable costs, in many cases well below market rates for simple models.

Contact us, we can help you gain or retain your MHRA WDA (H), whether you want to call it a Wholesale Distribution Authorisation, Wholesale Dealer Authorisation, Wholesale Dealer Licence, WL, WDL or WDA(H)

Welcome to a new paradigm!

#wherecommonsenseiscommon
#welcometoanewparadigm