A recent case brought by a pharmacy chain with a WDL challenged whether or not the Regulations allow for organisations operating both as registered pharmacies and licensed wholesale dealers can obtain medicinal products from other pharmacies which themselves do not hold a WDL.
The judge ruled that the law prohibits the purchase of medicines from pharmacies that do not have WDLs by pharmacies with the WDLs. The majority of pharmacies are unaffected and can continue to engage in the limited exchange of stock in the usual way.
Steve Lutener, head of regulation at PSNC, said:
“This judgment states very clearly that in order to comply with legislation, anyone holding a wholesale dealer’s licence (WDL) must only obtain medicines from another WDL holder or from a licensed manufacturer. This applies even to those licence holders who also operate as pharmacies. For contractors who also have WDLs, this judgment brings clarity over the Regulations and serves as a reminder of the need to follow them – the consequences for those failing to do so could be serious.
Contractors without WDLs should also be aware of the Regulations and the fact that they are entitled to supply medicines to other pharmacies only where it is in small quantities and is to meet the needs of a specific patient, as per the recent MHRA guidance. If the receiving pharmacy has a WDL, then no supplies can be made, other than by a WDL holder or other licence holder. We have recently seen promotional materials published by wholesale dealers offering to purchase products from pharmacies, including products that are in short supply. This judgment makes clear that this is not permitted unless the supplying pharmacy also has a wholesale dealer’s licence.”
For more information on the circumstances in which contractors without wholesale dealer’s licenses are allowed to trade contact Pharmacy Consulting. [email protected].
The MHRA have committed to investigating any suspected breaches of the regulations and have begun a proactive, targeted programme of inspection.
If you would like advice as to how to obtain a WDL, and or the roles and responsibilities of an RP contact Pharmacy Consulting. [email protected].
If you would like to attend an RP training day contact Chris on [email protected] and we can set up bespoke training to suit your specific needs or there is still space on our next course on the 14th of November.