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Off-Label and Unlicensed Medicines Policy


For a medicine to be marketed in the United Kingdom, it must have a Product Licence, now called a Marketing Authorisation, which is overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA). It is then classed as a licensed medicine. The licence will normally specify the indication, route, dose, and age range of the patients for which the medicine is intended to be used. The Medicines Act (1968) and other associated regulations provide specific exemptions which enable prescribers to:

 Use (or advise the use of) medicines for indications, doses, routes of administration outside the recommendations of the licence.

 Override the warnings and precautions given in the licence

 Use (or advise the use of) medicines for which there is no Marketing Authorisation in the United Kingdom i.e. an unlicensed medicine. These items may require importing to the United Kingdom via specialist wholesalers and permission from the MHRA.

In each case the prescriber has to be able to justify the action taken as being in accordance with a respected, responsible body of professional opinion. The prescriber should also be able to justify their selection of a drug in light of an informed risk/benefit assessment.

NB This Policy should be read in conjunction with all Medicines Management Policies, particularly the Trust Medicines Code and Trust Formulary


Link to the full Policy:

Off-Label and Unlicensed Medicines Policy

Link to the Equalities Impact Analysis:

Off-Label and Unlicensed Medicines Policy - EIA

Link to the Standard Operating Procedures:

High Dose Antipsychotic Prescribing SOP

Link to the SOP Equalities Impact Analysis:

 High Dose Antipsychotic Prescribing SOP - EIA