Often when there is no licensed UK product available there may be a suitable licensed product manufactured elsewhere in the world. It is possible to import this product for use by a UK patient under an MHRA importer's licence.
An import is defined as an unlicensed medicinal product sourced from outside the UK under an importers licence issued by the MHRA. These products have been specially sourced to meet a prescription ordered for individual patients without the need for the importer to hold a marketing authorisation for the medicinal product concerned.
Even if this product is licensed in its country of origin, once imported to the UK it becomes an unlicensed medicine (because there is no UK Marketing Authorisation) and hence is subject to the same regulations and considerations as an unlicensed medicine. Imported medicines are also reimbursed in the same way as Specials – see below.
The clear difference between an unlicensed import and a Special is that the import has undergone rigorous testing and clinical trials in the country of origin and is supplied with information on indications, dosages, side effects and interactions. This is particularly true if the medicine is imported from the US or an EU country – the MA guarantees the quality, safety and efficacy of the medicine.
A significant disadvantage of an import is that patient information will often be in a foreign language and may not be available in English - the pharmacist has a responsibility to ensure that any warnings and advice are provided to the patient in English. Numark's Information Services may be able to source English translations where necessary.
An import that is licensed in the country of origin is third in the RPS hierarchy of risk with only a UK or EU licensed medicine used within or outside its license having a lower net risk. The risks associated with an import increase if that product is itself unlicensed in the country of origin.