Partly as a result of the shortage of some branded medicines in the UK, the MHRA have tightened up their stance on pharmacies trading in medicines. A monthly list of products in UK short supply is published by PSNC, often containing towards 100 medicines each month. These medicines in particular must not under any circumstances be sold for export.
Licensed wholesale dealers of medicines cannot legally buy medicines from pharmacies unless the selling pharmacy has a Wholesale Dealers license (WDL). Whilst pharmacies may be approached by such traders to sell product, both the buyer and the selling pharmacy would be breaking the law if medicines were sold by the pharmacy to a Wholesale dealer, unless the pharmacy held a WDL itself.
Pharmacies can obtain a WDL by making a license application to the MHRA accompanied by a set of Standard Operating Procedures (SOPs) that describe in detail how the wholesale dealing side of the pharmacy will be operated. If a specific part of the pharmacy premises is not set aside exclusively for wholesale dealing, then the SOPS have to cover the whole pharmacy premises, and the MHRA can inspect the whole premises as part of their WDL licensing visit.
Whilst the MHRA have taken on temporary additional inspectors to deal with the increased number of pharmacy applications for WDLs, they will refuse to make a licensing inspection visit to any pharmacies which submit incomplete applications, or submit incomplete SOPs. Thus it usually pays to seek expert help in such a specialist area.