How are drugs licensed in the UK?
This page tells you about the drug licensing process in the UK. There is information below on
- Who licenses drugs in the UK
- The Medicines and Healthcare products Regulatory Agency (MHRA)
- The European Medicines Agency (EMA)
- Applying for a Europe wide licence
Before any medicines can be used in the UK they have to be licensed. Drugs are licensed for use in the UK either with a European licence or a national licence. Drugs are either licensed through the
- Medicines and Healthcare products Regulatory Agency (MHRA) for a UK licence
- European Medicines Agency (EMA) for a Europe wide licence
Below there are explanations of what these two agencies do.
The Medicines and Healthcare products Regulatory Agency (MHRA) license drugs in the UK. They support the European process as part of the EMA, and they also work with companies who only want to license a drug in the UK.
A pharmaceutical company can apply directly to the MHRA for a UK licence. Or they can apply to the EMA for a EU licence.
The MHRA has several areas of responsibility, including
- Regular inspections of laboratories and pharmaceutical companies
- Routine sampling of medicines
- Reviewing new evidence and assessing information
- Commissioning research into safety
- Gathering information on fake medicines
- Looking at trends in healthcare
- Enforcing regulations
The EMA is responsible for evaluating applications for licenses within the European Union (EU). Nearly all drugs in the EU are licensed through the EMA now. This is because a single EMA licence is valid in all the countries of the EU. Before the EMA was formed, companies had to apply to each country individually for a licence.
There are different systems within the EMA that pharmaceutical companies can use to license drugs. Once a drug has EU marketing authorisation, it is ‘licensed’, ‘registered’ or ‘approved’. All these terms mean the same thing.
But even medicines licensed through the EMA need to have permission from the MHRA to be prescribed in the UK.
It is possible, but quite unusual, for pharmaceutical companies to apply for a licence in the UK alone. If they want to, the pharmaceutical company apply to MHRA for a licence. The Commission on Human Medicines (CHM) provide independent advice to the MHRA about these applications.
As with EU approval, when a product is given marketing authorisation (a licence) by the MHRA, it cannot be prescribed until it is ‘launched’.
After a product has been launched doctors are allowed to prescribe it, either on the National Health Service (NHS) or through private health care. But only for people who meet the specific criteria of the drug’s licence. This often includes specific stages or types of a disease - for example, a drug may be licensed for one type of cancer, but not for another.
In practice, some doctors are not happy to prescribe a new drug at this early stage. They may feel there is a lack of information available about side effects or long term safety. Some doctors like to wait for more information to be published so they can be sure the drug is both safe and effective.
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