Medicines information
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.
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 forif it is to be licensed.
In the UK, licences can be granted by:
Before a licence can be granted, the medicine needs to be developed and tested.
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 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:
Finding and developing new medicinestakes around 10 to 15 years. It is a very expensive process. Estimates vary, but it can costmore than1 billion to develop a new medicine, from its discovery to gaining a licence.
The licence for a medicineincludes information such as:
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 ofproduct characteristics, medicines should come with a patient information leaflet. This leaflet provides patients with certain facts about the medicine. However,a patient information leafletis not necessary if all of the information fits on the medicinelabel.
Copies ofsummary of product characteristics and patient information leaflets are available from theMHRA andEMA websites.
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 licence 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.
As medicines are a crucial part of medical treatment, it is important to have a good understanding of them.
Before a medicine can be widely used in the UK, it must first be granted a licence.
All medicines that are licensed for use in the UK are strictly regulated to ensure they are as safe as possible.
The names of medicines can often be confusing, as the same medicine can sometimes be called different things.