I am sure plenty has been written and said about what I am sure many will see as an additional burden on wholesalers, this simple post is to help provide clarity about the scope of the regulations. Talking to colleagues and having read the regulations a number of times (I know that is really sad!!) it is clear that there is considerable ambiguity about who actually is required to submit these quarterly reports, mainly centring around what purchases needed to be reported. I think it is fair to assume that the wording was probably vague on purpose to allow future operational changes within the same regulations.

Anyway we now have clarity and this is good news for many wholesalers. The Department of Health and Social Care have clarified that it is only wholesalers supplying NHS ‘customers’ who need to report the purchase and sales information. If your business only supplies private, other wholesale or export customers you are not required to submit the quarterly data. The DHSC will be updating the Data Sharing Q&A to include this information in the near future (you can monitor updates via the following link https://digital.nhs.uk/data-and-information/data-collections-and-data-sets/data-collections/generic-medicines-and-special-medicinal-products ). This is the current position but as suggested above, could be subject to change in future so it is recommended that all wholesalers monitor for changes in this process.