Medicines information - Licensing of medicines

Before a medicine can be widely used in the UK, it must first be granted a licence.

While no medicine is completely risk free, a licence indicates all the proper checks have been carried out and the benefits of a medicine are believed to outweigh the risks.

This licence is also known as a marketing authorisation.

UK medicine licences

Licences are only granted if high standards of safety and quality are met during the whole development and manufacture of a medicine.

The product must also work for the purpose it is intended for if it is to be licensed.

In the UK, licences can be granted by:

• the Medicines and Healthcare Products Regulatory Agency (MHRA) – which can grant licences for medicines only in the UK
• the European Medicines Agency (EMA) – which can grant licences for medicines in the European Union (EU)

Before a licence can be granted, the medicine needs to be developed and tested.

Developing a medicine

Potential medicines are thoroughly researched using tissue culture, computer analysis techniques and animal testing.

All new medicines are required by law to be tested for safety, quality and effectiveness.

Data is needed from two separate species of animal before a medicine can be used in clinical trials involving humans.

Clinical trials

Clinical trials are research studies carried out in human volunteers and patients. They carefully test the safety and effectiveness of medicines using strict criteria.

If clinical trials are going to be carried out in the UK, the manufacturer of the medicine must first apply to the MHRA for permission to test its medicine.

In the UK, clinical trials are sponsored by:

• the NHS, through the National Institute for Health Research
• the Medical Research Council
• the Department of Health and other government departments
• medical research charities
• pharmaceutical and other healthcare companies

Finding and developing new medicines takes around 10 to 15 years. It is a very expensive process. Estimates vary, but it can cost more than £1 billion to develop a new medicine, from its discovery to gaining a licence.

Read more about clinical trials and medical research.

Stages of research

Four stages of clinical trials are used to investigate a new medicine:

• phase 1 – the medicine is tested in small numbers of healthy volunteers (up to 100 people) to find out how it works in the body and whether side effects increase at higher doses
• phase 2 – the medicine is tested in moderate numbers of people (several hundred) with a particular condition or disease to see how effective it is and identify common short-term side effects
• phase 3 – information about the medicine is gathered from a larger number of people (often several thousand) to see how well it works and how safe it is
• phase 4 – this happens after a licence has been granted, and involves studies to monitor the medicine on an ongoing basis to see if there are any unexpected side effects, or if it causes problems in certain categories of people

Read more about the phases of clinical trials.

What information does a licence include?

The licence for a medicine includes information such as: 

• what health condition it should be used to treat
• what dose should be used
• what form it takes – such as a tablet or liquid
• who can use the medicine – for example, only people above a certain age
• how long treatment with that medicine should last
• warnings about known safety issues – such as side effects and interactions with other medicines
• how the medicine should be stored
• when the medicine expires

This information is usually included in the summary of product characteristics. This is a leaflet that comes with the medicine to inform healthcare professionals about how it should be used.

As well as a summary of product characteristics, medicines should come with a patient information leaflet. This leaflet provides patients with certain facts about the medicine. However, a patient information leaflet is not necessary if all of the information fits on the medicine label.

Copies of summary of product characteristics and patient information leaflets are available from the MHRA and EMA websites.

Unlicensed medicines

Sometimes a healthcare professional may recommend an unlicensed medication or an off-label use for a medicine.

Off-label use means that the manufacturer of the medicine has not applied for a license for it to be used to treat your condition. In other words, the medicine has not undergone clinical trials to see if it is effective and safe in treating your condition.

However, the medicine will have a licence to treat another condition and will have undergone clinical trials for this.

Many experts will use an unlicensed medication if they think the medication is likely to be effective and the benefits of treatment outweigh any associated risk.

If your specialist is considering prescribing an unlicensed medication, they should inform you it is unlicensed, and discuss possible risks and benefits with you.