Importation Of Unlicensed Medicines

In UK, medicines should have a valid Product Licence before it can be marketed, unless exempt . One of the exemptions relate to the importation and supply of unlicensed relevant medicinal products (commonly known as 'specials') to meet the clinical needs of some patients that cannot be met by licensed medicinal products, commonly referred to as 'named patients'. 


Any pharmaceutical wholesaler who intends to import unlicensed medicines should inform MHRA.

The relevant licences required to import are:

• for import from within the European Economic Area (EEA):  a Wholesale Dealer's Licence valid for import and handling unlicensed relevant medicinal products

• for import from outside of the EEA: a Manufacturer's 'Specials' Licence valid for import

Importation may proceed unless the importer has been informed by the MHRA within 28 days of the date of the MHRA acknowledgement letter that it objects to importation.

Objections by MHRA may be raised to import where:

• it has concerns about the safety or quality of the product

• there is an equivalent licensed medicinal product available that meets the needs of the individual patient

• it is not satisfied that there is a 'special need' for the supply to an individual patient.

It is MHRA policy that 'special need' must be clinical in nature. Reasons of cost, convenience or institutional need are not acceptable.

It is the importer's responsibility to ensure that the products being imported comply with the Transmissible Spongiform Encephalopathies (TSE) Regulations.