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Guidance around the urgent supply of unlicensed medicines imported out-of-hours by UK hospitals.

Over the past few months there have been a few incidents where urgent supplies of unlicensed medicines have needed to be imported out-of-hours by UK hospitals. Under normal circumstances hospitals may use the services of specialist importers of unlicensed medicines, however, this can be difficult at weekends, or during public holidays. Some hospitals hold suitable licences to submit their own notifications for import of unlicensed medicines, but in recent incidents, although licences have been held, the licences did not have the necessary authorities to import unlicensed medicines and urgent variations to licences have needed to be applied.

We would encourage all holders of WDA(H) and MS licences who may need to urgently import unlicensed medicines to review whether they need to apply for variations to ensure their licences hold the correct permissions. This is especially relevant to hospitals who may specialise in unusual or rare acute conditions.

The following is a summary of the relevant conditions:

  • A Wholesaler Dealer’s Authorisation, WDA(H) is required for import of unlicensed medicines coming from within the European Economic Area (EEA). The licence must bear the ability to handle medicine with and without a marketing authorisation in the EEA and intended for the EEA market.
  • A Manufacturer’s “Specials” Licence (MS) is required for import of unlicensed medicines coming from outside the EEA and must state that unlicensed medicines are imported from outside the EEA at this site.

For full details please see our webpage Import a human medicine and Guidance Note 14 The Supply of unlicensed medicinal products ‘specials’

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