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Bisantrene granted unlicensed medicine approval in UK
Race Oncology is pleased to announce that approval has been received from the Medicines and Healthcare products Regulatory Agency (MHRA) for importation and distribution of Bisantrene as an unlicensed medicine in the UK.
The letter from the MHRA was received by Race’s distribution partner, Durbin PLC, on 20 June 2018.
Under MHRA regulations, the supply of unlicensed medicines in the UK is allowed subject to MHRA approval and in response to unsolicited requests from doctors for treating patients with unmet medical needs.
The current approval allows Durbin to import and supply Bisantrene to UK-based doctors and hospitals in response to such requests.
The initial approval is for 75 courses of treatment (14 vials per course), but Durbin can apply for additional approvals as needed.
No further approval is needed to commence supply of Bisantrene in response to physician requests or to invoice hospitals that receive the drug.
In the UK, the use of unlicensed medicines is typically funded by the hospital that administers the drug.
The MHRA approval also allows Durbin to supply Bisantrene outside the UK to all 28 other countries in the EEA (European Economic Area), subject to local approval and importation rules in each country.
For example, in France, an ATU is required in order to import and supply an unlicensed medicine.