A legal position summary regarding the sale, supply or administration of off-label/unlicensed products under Schedule 17 of the Human Medicines Regulations 2012

About Schedule 17 of the HMR 2012

Exceptions to the general rule for which certain healthcare professionals can sell, supply, and/or administer medicines to patients under Schedule 17 of the Human Medicines Regulation 2012 are also known as exemptions. Further information on exemptions can be found on the MHRA website.

Specific information relating to the supply/administration of unlicensed and off label medicines when practising under Schedule 17 of the Human Medicines Regulation 2012 exemptions are detailed below.

Unlicensed medicines

Unlicensed medicines cannot be administered, sold or supplied under the Schedule 17 exemptions, including under Written Instructions for Occupational Health Services.

The MHRA has confirmed that an unlicensed product can only be supplied in response to the order of a doctor, dentist, independent nurse or pharmacist prescriber, or a supplementary prescriber for use by their individual patients on their direct personal responsibility. It could then be administered by a health professional but the administration would have to be in accordance with the patient specific directions of the doctor, dentist or independent nurse/pharmacist prescriber or supplementary prescriber.

Off-label medicines

Medicines to be used for an off-label indication can be administered, sold or supplied under the Schedule 17 exemptions.

The MHRA has confirmed that medicines listed in the exemptions can be used off-label. To be considered only when such use is clearly justified and supported by best clinical practice, such as national guidance. Health professionals should consider informing patients about the license for their medicines, in line with prescribing guidance published by the General Medical Council.

Further information

Further SPS resources on unlicensed medicines are available via the following links:

Explaining the licensed status of medicines

Understanding unlicensed medicines

Using unlicensed medicines

Governance principles for unlicensed medicines

Making unlicensed medicines

Purchasing Specials

Update history

  1. Minor formatting update
  1. Additional links added to SPS unlicensed medicine resources
  1. Links to related SPS pages added
  1. Formatting updated - no change to content
  1. Content reviewed - no changes required
  1. Published

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