Shortages and supply chain obligations – Guidance for registered pharmacies that also hold wholesale dealer’s licences

In November 2009, the MHRA together with the Department of Health and eight other bodies, published guidance on “Trading medicines for Human Use: Shortages and Supply Chain Obligations".

The intention of the guidance was to set out the key legal and ethical obligations on manufacturers, wholesalers, NHS trusts, registered pharmacies and dispensing doctors in relation to the supply and trading of medicines in order to maintain an appropriate and continued supply of medicinal products to patients in the UK by marketing authorisation holders and distributors.

The MHRA would like to clarify that it considers that the guidance, to the effect that a registered pharmacy that is also a licensed wholesale dealer:

“should ensure that its 'retail' and 'wholesale' transactions are clearly separated and fully documented. Businesses should not procure medicinal products from a wholesaler for pharmacy use and then transfer these products to the wholesale side of the business for supply by way of wholesale dealing.”

…is a statement of best practice and not a statement of any legally binding obligation.

The MHRA considers it to be best practice, although not a legal obligation, for a registered pharmacy, which also holds a wholesale dealer’s licence, to ensure that its 'retail' and 'wholesale' transactions are clearly separated and fully documented. This is to help ensure that:

• medicinal products for wholesale supply are kept in the licensed distribution chain at all times, under a full quality system that is expected to be operated by licensed wholesale dealers and Good Distribution Practice controlled conditions before they are distributed for retail supply
• the obligation in Article 81 of European Directive 2001/83/EC, for the maintenance of an appropriate and continued supply of medicinal products detailed below is being met by licensed distributors; this is because those in the supply chain can be clearer as to which medicines are going to meet the needs of patients in the UK.