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UK Named Patient Prescribing for Sativex®

GW announces that it has been informed by the Home Office that the Drugs Minister, Paul Goggins, has confirmed that Sativex® oromucosal spray, its cannabis-based medicine, may be imported from Canada to satisfy its prescription to individual patients in the UK as an unlicensed medicine. This development is in response to enquiries from a number of UK doctors and individual patients who have been in contact with the Home Office to request access to Sativex.

In accordance with the Medicines Act, a medicine which has yet to be licensed in the UK may be prescribed and supplied in response to an unsolicited request to fulfil the special needs of an individual patient under a physician’s direct personal responsibility. The basis on which Sativex may be imported, therefore, is the clinical judgement of doctors in relation to specific nominated patients.

This development follows the approval of Sativex by Health Canada in April 2005. The medicine has been available on prescription in Canada since late June.

More recently, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued to GW a Wholesale Dealer’s (Importation from non-EU countries) Licence, and has not objected to the importation of Sativex under the regulations for importation of medicines unlicensed in the UK.

Sativex will remain a Schedule 1 controlled drug in the UK in line with stated government policy. This means that the prescribing of Sativex can only be permitted under Home Office licence. The Home Office will therefore be developing a licensing regime to fit these circumstances. GW expects to discuss the implementation practicalities with the Home Office over the coming weeks.

Clearance for supply on an unlicensed basis does not affect GW’s plans to seek full regulatory approval from the MHRA for Sativex in the UK. The Company is currently conducting a number of further Phase III trials and is still planning to submit an application for Marketing Authorisation to the MHRA during 2006. Only after such an approval is granted can the product be promoted in the UK.

15/11/2005 - for more info click here

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