Use of medicines without a UK Product Licence

Also see 'Trust Medicines Policy', appendix 13

When a medicine is used which does not have a Product Licence, the liability for untoward events may rest with the Trust, the prescriber or the supplier. New requests must be approved by the Medicines Management Committee in the following way:

Request procedure

  1. Prescribers must complete a "Request & Risk assessment Form for Unlicensed Medicine", requested from the Medicines Information Centre (ext 3331) or available on the Intranet under 'Trust Medicines Policy', appendix 13.

  2. A review of the evidence for use will be written for the Medicines Management Committee (MMC).

  3. The MMC will register use of the product when appropriate. This will ideally be done prospectively, except where treatment is urgent when it will be done retrospectively.

  4. The quality, formulation and stability of the preparation must be deemed satisfactory by a pharmacist before the material can be used.

  5. A register of these products will be maintained by the Pharmacy department.