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Medicines information

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

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:

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.

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Medicines information

All medicines that are licensed for use in the UK are strictly regulated to ensure they are as safe as possible.

All medicines licensed for use in the UK are strictly regulated to ensure they are as safe as possible.

The entire process of medicine development is controlled, and monitoring continues after medicines become widely available.

In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is the organisation that looks after the safety of prescribed medicines and other health devices and equipment.

Its main job is to make sure that medicines and medical devices, from painkillers to pacemakers, work properly and are acceptably safe.

The MHRA works closely with the European regulator, the European Medicines Agency (EMA), which oversees the safety of medicines across Europe. In some cases, the EMA takes the lead in licensing medicines used in the UK.

Ensuring safety

No product is completely risk free, so the MHRA uses as much information as it can to ensure the benefits of medicines for patients justify any possible risks.

Both the MHRA and EMA routinely carry out inspections to check all parts of the medicine development process, from testing to manufacturing, are carried out in line with strict regulations.

The MHRA assesses the results of clinical trials to decide whether or not new medicines should be licensed for use. Clinical trials are research studies that carefully test the safety and effectiveness of medicines, using strict criteria.

No medicine or medical device can be used in the UK until the MHRA or EMA has given it a licence that sets out how it should be used and which health condition it should be used to treat. Read more about licensing medicines.

However, no medicine is completely risk free and medicines can affect different people in different ways. For example, depending on your age, sex and what other medicines you are taking, a medicine might cause you to have a side effect that someone else who is also taking it wouldn't have.

Ultimately, you and your healthcare professional have to weigh up the pros and cons of each medicine when deciding on the most appropriate treatment.

Monitoring safety

The MHRA continues to monitor the safety of medicines once they are in wider use by checking reports about any problems or defects, and reviewing new scientific evidence on different medicines.

If any problems arise, the MHRA can take action to deal with it. This may mean alerting healthcare professionals about a potential issue with a medicine, and withdrawing a medicine from the market if it becomes apparent that side effects outweigh the benefits.

Reporting an adverse effect

The Yellow Card Scheme is a special reporting system for possible adverse effects of medicines.

If the healthcare professional treating you thinks a medicine may have caused a potentially concerning effect, they will fill in a report and send it to the MHRA.

You can also use the Yellow Card Scheme yourself, or on behalf of a child or adult in your care, by:

  • calling 0808 100 3352 to report an adverse effect over the phone
  • asking your pharmacist for a Yellow Card form you can send in the post
  • logging on to the Yellow Card Scheme website to report an adverse effect online

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Medicines information

The names of medicines can often be confusing, as the same medicine can sometimes be called different things.

The names of medicines can often be confusing, as the same medicine can sometimes be called different things.

Many medicines have two names:

  • the brand name – this is given to a medicine by the pharmaceutical company it is developed by
  • the scientific or generic name – named for the active ingredient of the medicine, which is decided by an expert committee

For example, sildenafil is the generic name of a medicine used to treat erectile dysfunction. However, the company that makes sildenafil, Pfizer, sells it under the brand name Viagra.

Both medicines have the same clinical effect, but each separate manufacturer can give it a different name.

It is similar to buying branded goods or a supermarket's own label – both products do the same job, but the supermarket's own version is usually cheaper.

Brand names 

During the first few years a new medicine becomes available, it is usually marketed as a brand under a name given by the pharmaceutical company that developed it.

Companies take out patents (exclusive rights) on each new drug they discover to ensure they regain the money they spent on its development – which can be as much as £1 billion – and make a profit.

Having a patent means only that company can produce the medicine for a certain length of time. In the UK, the standard patent lasts 20 years, although this can sometimes be extended by up to another five years.

On average, it takes the first 10 to 15 years of this period to develop the medicine and obtain a licence. Read more about licensing medicines.

During the remaining years, only that company can produce and sell the medicine to recover their costs and make a profit. They give the medicine a brand name for marketing purposes to make it more memorable, such as Viagra.

Generic names 

Once the patent protection expires, other companies can produce their own version of the medicine. For example, ibuprofen is the generic name of a medicine commonly used to treat pain and inflammation.

There are many branded versions of ibuprofen, such as Nurofen and Hedex. However, it is also sold under the generic name ibuprofen, but made by different manufacturers, such as Boots or Tesco.

Generic medicines are usually cheaper because there are fewer research and development costs, but they contain the same active ingredient as the branded products.

Generic medicines go through the same detailed safety and quality requirements as the original branded product.

Read more about regulating the safety of medicines.

Prescribing generic medicines

Prescribers (people who prescribe medicines, such as GPs) are encouraged to prescribe medicines by their generic name. This is because generic medicines are usually as effective as the branded versions, but can cost up to 80% less.

This frees up NHS resources to pay for other treatments. It also gives the pharmacist the widest choice of products to dispense. This can be important, particularly if there is a shortage of a particular product.

Switching to a generic medicine

If your prescriber changes your regular prescription from a branded medicine to a generic version, they should tell you about the change before you collect your prescription.

This is to ensure you understand that although your medicine may have a different name, it will still contain the same active ingredient. Your pharmacist can also be a helpful source of information and advice when this happens.

When you pick up your prescription, the medicine may look different and there will be a different name on the label. However, it will contain the same active ingredient as the medicine you used before.

Generic medicines with different activity

In rare cases, it is important for a patient to stay on the branded medicine previously prescribed for them, rather than changing to a generic medicine. In such cases, the branded medicine is the most suitable product.

Some examples of when you should keep taking your brand of prescribed medicine include:

  • epilepsy medicines – these should be treated with care because different versions may have slight differences in the way they are absorbed, which can cause big differences in their effect; for example, prescribers may decide the branded version of lamotrigine (Lamictal) is more suitable than the generic version
  • modified-release preparations of medicines – such as modified-release versions of theophylline, nifedipine, diltiazem and verapamil; a branded version may sometimes be a better option than the generic equivalent as they can be absorbed differently
  • ciclosporin – a medicine that suppresses the immune system (the body's natural defence system); different branded versions may cause different levels of ciclosporin in your blood
  • mesalazine – which is used to treat ulcerative colitis (a long-term condition that affects the colon); the way that mesalazine is absorbed varies between different brands
  • lithium – this treats a number of mental health conditions; different brands vary widely in terms of how much of the medicine is absorbed and becomes active
  • beclometasone dipropionate CFC-free inhalers to treat asthma – there are two inhalers that contain the same active substance (beclometasone dipropionate), but one is much stronger

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