Where it is essential to supply an unlicensed medicine the importation of medicines that have been licensed by a regulatory authority in another country is an option worth considering61 62.
The preparation selected for import should be licensed for use in a country with equivalent or similar licensing arrangements and regulatory standards to the UK (eg. EU, USA, Canada, Australia). Whilst this will provide assurance that the quality, safety and efficacy of the medicine have been reviewed by a competent regulatory authority, care should be taken to ensure that the medicine has been licensed for use in the country of origin and available on the market there, rather than being manufactured exclusively for export. It should also be remembered that the presence of a non-UK marketing authorisation confers no legal status on the medicine in the UK and that importation can only take place through a company holding a Wholesale Dealer (Import) Licence for import from within the European Economic Area (EEA), and a Manufacturer's 'Specials' Licence (Import) for import from outside of the EEA.
The procuring pharmacist should also ensure that the company used for importation has adequate quality systems in place to ensure that the medicine comes from a reputable source; that counterfeit detection measures are in place; and that the cold chain (where appropriate) is maintained to the point of delivery. Counterfeit medicines account for less than 1% of the value of the pharmaceutical market in industrialised countries with effective regulatory systems, however, more than 30% of the medicines on sale in Africa and parts of Asia and Latin America can be counterfeit95.
From a clinical perspective, the procuring pharmacist also needs to be aware that the product’s licence may not cover the relevant age group or specific clinical indication. Therefore, it is important to review the SPC and patient information leaflet (PIL) to ensure that they are appropriate for the intended use and provide alternative guidance if necessary.
When importing a product from a non-English speaking country, provision must be made to ensure that the product is labelled appropriately and that sufficient guidance is provided to the clinician and patient to ensure safe use.
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