The DH has published updated guidance for manufacturers, wholesalers, NHS trusts, dispensing pharmacies and dispensing doctors in relation to the supply and trading of medicines.

The guidance is relatively concise and provides as follows:

  • It reminds those who wholesale deal any medicinal product for human use of the need to hold the appropriate licence and that conducting any of the specified activities set out in the Human Medicines Regulations 2012 (the regulations) without the necessary licence is a criminal offence
  • The regulations require the maintenance of appropriate and continued supply of medicinal products by marketing authorisation holders and distributers
  • Where a manufacturer distributes medicines by way of wholesale dealings, he must comply with the requirements as if he was the holder of a wholesale dealer’s licence including the requirement to ensure the continued supply of medicinal products to pharmacies etc, so that the needs of UK patients are met. A manufacturer failing to comply with the requirements of the regulations could be subject to regulatory action by the Medicines and Healthcare products Regulatory Agency (MHRA)
  • The holder of a wholesale dealer’s licence may only legally obtain medicinal products from licensed manufacturers or licensed wholesale dealers in the UK or EEA member states, breaching this requirement could result in regulatory action and/or criminal prosecution
  • Legal entities with premises registered as a pharmacy and also licensed as a wholesale dealer by the MHRA would be legally required to comply with the legislation relating to both registration and licensing
  • The regulations also require a holder of a wholesale dealer’s licence to ensure the appropriate and continued supply of such relevant medicinal products to pharmacies and other authorised retailers of medicinal products so that the needs of UK patients are covered
  • If a wholesaler chose to trade medicines for export that were in short supply in the UK, and as a result the needs of UK patients were not met, the holder of the wholesale dealer’s licence could be in breach of the regulations and could face regulatory action and/or criminal prosecution. The requirements apply to all holders of wholesale dealers licences, including pharmacists who hold a wholesale dealer’s licence
  • The guidance also contains a reminder of the 2009 letter from the Chief Pharmacist, who wrote to NHS trusts stressing that the exporting of medicines for short-term financial gain is unacceptable as this threatens the supply chain and therefore patient care