§ Ms Blears
Single rubella vaccine and single measles and mumps vaccines are licensed in the United Kingdom. However, the pharmaceutical companies that hold the UK marketing authorisations for single measles and mumps vaccines do not manufacture the products for, or market them in, this country and the vaccines being prescribed and administered are imported unlicensed medicines. Licensed single rubella vaccine is currently available in the UK. However, unlicensed rubella vaccine may also be imported on occasions when the licensed vaccine is unavailable.
An unlicensed medicine, such as a single vaccine, may only be imported in accordance with The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1999 No. 4. An importer must hold the appropriate Wholesale Dealer's or Wholesale Dealer's Import Licence issued by the Medicines Control Agency (MCA), and is required to notify the MCA on each occasion that they intend to import such a product. Importation may proceed unless the importer has been informed by the MCA that it objects to importation. The MCA may object and prevent importation if it has concerns about the safety or quality of the product, or if there is an equivalent licensed medicine available. The maximum quantity that may be imported per notification is defined in the regulations.