Becoming a Pharmaceutical Wholesale Dealer

by | Nov 29, 2021 | Blog, MHRA, WDA(H)

Becoming a Pharmaceutical Wholesale Dealer – Many new clients contact us for information and help on setting up a new business as a Pharmaceutical Wholesale Dealer. This can appear to some to be a potentially lucrative way of exploiting what they believe may be a gap in the market, for example for the export of medicinal products overseas to countries outside the European Economic Area (EEA). Others may just wish to supply small quantities of generics to pharmacies in their local area.

Regardless of the ultimate business aim, it is vitally important that anyone looking to become a Pharmaceutical Wholesale Dealer does some preliminary fact finding and research to gain at least a basic understanding of what is required.

In order to trade in medicinal products a Wholesale Dealers Authorisation, issued by the MHRA, is required and a WDA licence must have a named Responsible Person nominated on it.  The MHRA will assess the RP during the initial inspection (prior to the WDA being granted) to ensure they have the required knowledge, experience and training to be able to discharge the responsibilities placed on them.

The MHRA will also need to see evidence that the WDA applicant has a fully functioning Quality Management System in place before the licence will be granted.

There are various resources available on the MHRA section of the .gov.uk website that can help a prospective Pharmaceutical Wholesale Dealer understand what is required to set up this type of business. A scoping call with one of our experienced consultant RPs can also be a very useful resource for anyone looking to expand into this area. Scoping calls typically last up to two hours during which time the consulting RP will seek to understand the type of business model being proposed and give some guidance on the suitability and likely success of the venture. To book a scoping call with one of our RPs please contact PCL.

https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

https://mhrainspectorate.blog.gov.uk/2018/06/15/the-repsonsible-person-named-on-the-wda-part-1-raising-the-profile-of-the-rp/

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