Why are medicines licensed by the MHRA?

Medicines are licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA) to ensure that they provide benefit and are acceptably safe.

What does 'acceptably safe' mean?

Side effects from medicines can be very minor, but they can also be serious. To assess whether a medicine is acceptably safe, its benefits are compared with the possible side effects it could cause.

A high level of side effects may be acceptable for a medicine used to treat a life-threatening condition, but not in a medicine used to treat a common minor illness.

Licensed medicines

Before a medicine can be sold in the UK, a marketing authorisation (formerly product licence) from the MHRA is required. The MHRA will only issue a marketing authorisation if:

  • clinical trials have proved that the medicine successfully treats the condition it was developed for
  • the medicine's side effects are acceptable, and
  • the medicine meets high safety and quality standards

How are medicines tested?

All medicines must, by law, be tested on animals before being given to humans. To make sure medicines are safe and effective in humans, they must also be tested on people in clinical trials.

Information from clinical trials is given to the MHRA when the manufacturer applies for a marketing authorisation.

Prescribing medicines off-label

Wherever possible, doctors should try to prescribe a licensed medicine for your condition. However, doctors may sometimes prescribe a medicine for use outside the terms of its marketing authorisation. This is called off-label prescribing.

Doctors may prescribe a medicine off-label if:

  • there is no available licensed product
  • that medicine is the best one available to treat your condition

Examples of prescribing off-label are shown below:

  • a medicine licensed for adults in tablet form may be prescribed as a liquid for children
  • if a doctor thinks a medicine will be effective in treating your condition, they may prescribe it even though it's not licensed to treat that condition (for example, some antidepressants can be used to treat pain)

Doctors should inform you if they are prescribing off-label.

Prescribing unlicensed medicines

Doctors may sometimes prescribe unlicensed medicines. A medicine that's unlicensed doesn't have a marketing authorisation. For example:

  • you may have agreed to receive an unlicensed medicine as part of a clinical trial
  • the medicine may be waiting for approval from the MHRA
  • a patient may have a special clinical need that cannot be met by a licensed medicine for example, they are allergic to an ingredient or cannot swallow tablets
  • a doctor may prescribe medicine for an individual patient in a form that's not readily available to be made up as a special preparation by a pharmacist

Doctors should inform you if they are prescribing an unlicensed medication.

Dispensing unlicensed medicines

In some cases, the pharmacist may arrange to get an unlicensed medicine from a manufacturer who makes it specially under a "Specials" manufacturing licence.

If a doctor specifies a medicine to be made up as a special preparation for a patient, the pharmacist will make up the medicine using raw ingredients. This method is called extemporaneous dispensing.

Read the answers to more questions about medicines.

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Page last reviewed: 05/09/2013

Next review due: 04/09/2015