This section provides answers to the some of the most frequently asked questions about the MHRA.
- What does the MHRA do?
- How does the MHRA regulate medicines and medical devices?
- What does the MHRA not control?
- Is the MHRA part of the NHS?
- How does the agency ensure its staff are not biased in their evaluations?
- How is the MHRA funded?
- How do I make payments to the MHRA?
- Why does the MHRA accept money from pharmaceutical industry? Isn’t this a conflict of interest?
- Surely this means that the licensing of medicines is subsidising the regulation of medical devices?
- How are devices approved by the MHRA and how does this differ from medicines approval?
- What is the difference between the MHRA and the EMA?
- Why do more side effects show up after the medicine has been licensed?
- Surely if medicines are regulated properly then they ought to be safe?
- What sanctions does the MHRA have against companies that break the rules?
- How can I register to receive the MHRA’s email alerts?
- I’m about to go on holiday. Can I take my medicine abroad?
- Why is my medicine not available on the NHS, who controls this?
- How do I go about getting onto a clinical trial?
- I want to report a side effect that I am experiencing with this medicine or medical device
- Can you help me with advice on my current treatment or medical condition?
- What should I do with my unwanted and out of date medicines and medical devices?
- I’ve recently bought this medicine and it is out of date
- Are there any regulations concerning the positioning of medicines in retail outlets?
- Are food supplements medicines?
- I can’t find the answer to my question. Who should I contact in the MHRA to ask?
About the Agency
1. What does the MHRA do?The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
2. How does the MHRA regulate medicines and medical devices?
Underpinning all our work lie robust and fact-based judgements to ensure that the benefits justify any risks. This is achieved through:
- authorising before medicines are marketed, taking both their safety and effectiveness into account
- ensuring clinical trails meet robust standards and safeguard patient’s interests
- inspecting the quality of medicines as manufactured and distributed
- overseeing UK Notified Bodies that audit medical device manufacturers
- encouraging everyone to report suspected problems with both medicines and devices and then investigating these reports
- Investigating, and prosecuting where necessary, cases of non-compliance including advertising claims.
3. What does the MHRA not control?
The MHRA does not regulate cosmetics, food, controlled drugs and veterinary medicines.
4. Is the MHRA part of the NHS?
No. It is one of the agencies of the Department of Health (external link).
5. How does the Agency ensure its staff are not biased in their evaluations?
Each member of staff completes a declaration of interest and their manager must ensure they do not do work which might be compromised by that interest. From November 2005 all staff and immediate members of their families are not allowed any financial or other interests in the industry.
6. How is the MHRA funded?
The costs of medicines regulations are met by fees from the pharmaceutical industry. In contrast, the funding of device regulation is from the Department of Health (external link).
7. How do I make payments to the MHRA?
The details of the MHRA's bank accounts to be used when remitting payment of your invoice/s or in advance of your application/s are available in our bank account details section
8. Why does the MHRA accept money from pharmaceutical industry? Isn’t this a conflict of interest?
Companies have to pay a fee for their marketing authorisation but we don’t seek business from them. Any complex licensing decisions are referred to the Agency’s independent advisory committees. These members must register any interests they have in the industry. They must declare any specific ones and take no part in discussions on that subject.
9. Surely this means that the licensing of medicines is subsidising the regulation of medical devices?
No. There is no cross subsidy between the funding for medicines and devices.
The regulation of medicines and medical devices
10. How are devices approved by the MHRA and how does this differ from medicines approval?
The MHRA does not 'approve' medical devices of any class. Class I registration is purely an administrative measure; Class I CE-marking is based on self certification by the manufacturer. Medium and high risk devices, and those Class I medical devices supplied sterile or which have a measuring function require the intervention of a Notified Body to carry out a compliance assessment and issue a CE certificate before manufacturers can place their products on the market.
The licensing of medicines is based on the submission of data to the MHRA (or the European Medicines Agency (EMA) (external link) for a single Community-wide authorisation) who will perform an assessment before reaching a decision as to whether to grant or refuse a licence. A licence must be granted before the product can be placed on the market.
11. What is the difference between the MHRA and the EMA?
Most new types of medicine are licensed by European Medicines Agency (EMA) (external link), to ensure that it is available to, and used in the same way, across all the member states of the European Union (EU). The breast cancer treatment Herceptin and the antiviral medicine Tamiflu are some examples.
Any medicine licensed by the EMA is valid across all EU member states whereas a licence issued by the MHRA is valid in the UK only.
12. Why do more side effects show up after the medicine has been licensed?
At the time of licensing a medicine will only have been tested in a relatively small number of patients and rare side effects may not be detected. When it is used in normal clinical practice, much larger numbers of patients are exposed in a less-controlled environment and unexpected, rarer and sometimes serious side effects may be seen for the first time. We monitor the safety of all medicines in routine clinical practice throughout their marketed life to identify any new safety issues.
13. Surely if medicines are regulated properly then they ought to be safe?
No medicine is risk free. We will know about some of the risks when we license a medicine but some risks will not be known about until later. If we refused a licence because a medicine had some risk or other associated with it, there would be very few useful medicines available. Many medicines bring great benefit to patients; we weigh these benefits against the known risks when we license them. If the benefits justify the risks we license the medicine. And we make sure that people are informed about the risks so they can make their own minds up.
14. What sanctions does the MHRA have against companies that break the rules?
The Agency prosecutes individuals or companies that break the law. If found guilty they can receive a maximum of two years imprisonment, with an unlimited fine at the judge’s discretion.
Industry healthcare professionals
15. How can I register to receive the MHRA’s email alerts?
You can subscribe to our email alerting service by completing the registration section
16. I’m about to go on holiday. Can I take my medicine abroad?
Yes, if it’s for your own personal use. We also recommend you carry some form of documentation, a copy of the prescription or letter from your GP, clarifying the medicines you are carrying on your person.
17. Why is my medicine not available on the NHS, who controls this?
The MHRA does not control the availability of medicines on the NHS. The National Institute for Health and Clinical Excellence (NICE) (external link) provides guidance on the use of medicines for the NHS, the Department of Health (external link) decides what can be available on the NHS.
18. How do I go about getting onto a clinical trial?
The MHRA does not recruit volunteers for trials. You should speak to your doctor.
19. I want to report a side effect that I am experiencing with this medicine or medical device
If you think you or someone else has had an unwanted or harmful reaction we would like to know. This can be done through our website report a safety problem section.
20. Can you help me with advice on my current treatment or medical condition?
The Agency is not able to advise individual patients on their treatment. We suggest you discuss this with your own healthcare profession such as your doctor or local pharmacist.
21. What should I do with my unwanted and out of date medicines and medical devices?
These should be returned to your local pharmacist for their safe destruction.
22. I’ve recently bought this medicine and it is out of date
If this was supplied from a pharmacy then you should contact the General Pharmaceutical Council on 020 3365 3400. This is the professional body that regulates pharmacists in this country. If you bought it elsewhere please email the details to email@example.com
23. Are there any regulations concerning the positioning of medicines in retail outlets?
The MHRA has no control on positioning of medicines as this is not covered by medicines legislation. However, since medicines are labelled to the effect that they should be kept out of the reach of children, we do advise that retailers should position them appropriately.
24. Are food supplements medicines?
Food supplements are products containing concentrated sources of vitamins and minerals. Food supplements are regulated by the Food Standards Agency (external link). Like all foods it is not legally possible to make medicinal claims for food supplements as both food and medicines legislation prohibits this. To decide whether a product sold as a supplement is actually a medicine, the MHRA look at the ingredients of the product and how the product is presented to the public. In general terms, products which only contain vitamins and minerals are not normally regulated as medicinal products unless they are marketed to treat or prevent disease, or adverse medical conditions.
25. I can’t find the answer to my question. Who should I contact in the MHRA to ask?
You can either email the Customer Services team or telephone on 020 3080 6000.