Not physically handling medicinal products? Wholesale Distribution or Brokering?

by | Nov 17, 2014 | Blog, Quality Systems, Transportation, WDA(H), WDA(H)

We often hear people stating that they don’t actually handle medicinal products, therefore they do not need a WDA – this is not strictly a correct statement. Even if you do not, physically, handle medicines, you will need to either register as a broker with the MHRA or apply for a WDA (Wholesale Distribution Authorisation).

Brokering- Register with MHRA

Companies who are involved in the sale or purchase of medicinal products without selling or purchasing those products and who do not own or handle the products are brokers. UK Brokers require a permanent address and contact details within the UK, a (reduced) quality system and registration with the MHRA.

Wholesale Distribution – Apply for WDA

A WDA is required for any company who are procuring, storing or supplying medicines. Even a company does not physically handle the product, but are involved only in the purchase and sale of medicines, is required to hold a valid Wholesale Distribution Authorisation and comply to the principals of Good Distribution Practices (GDP). You will need to have a permanent address, a full quality system and a Responsible Person.

If you are unsure if you should register as a broker or apply for a WDA, we are happy to advise you. Give us a call on 01252–302342.

Testimonials

Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
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