Frequently asked questions about the MHRA

If the answer to your question is not here, please either e-mail our Central Enquiry point or telephone on 020 7084 2000.

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.

How does 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. 

What does MHRA not control?
MHRA does not regulate cosmetics, food, controlled drugs and veterinary medicines.

Is MHRA part of the NHS?
No. It is one of the agencies of the Department of Health.

What sanctions does 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.

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.

Why does 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.

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.

How is 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.

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 the section below:
› Our bank account details

How can I get on the device alert mailing list?
Printed copies are available on our website. If you want to get on the mailing list send an e-mail or alternatively phone on 020 7084 3272

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.

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.

I’m about to go on holiday. Can I take my medicine abroad?
Yes, if it’s for your own personal use.

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.

Why is my medicine not available on the NHS, who controls this?
MHRA does not control the availability of medicines on the NHS. NICE provides guidance on the use of medicines for the NHS, the Department of Health decides what can be available on the NHS.

How do I go about getting onto a clinical trial?
The agency does not recruit volunteers for trials. You should speak to your doctor about this.

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”.

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.

I’ve recently bought this medicine and it is out of date
If you were sold this from a pharmacy shop you need to contact the Royal Pharmaceutical Society of Great Britain on 020 7735 9141. This is the professional body that regulates pharmacists in this country.

If you bought it elsewhere you will need to e-mail info@mhra.gsi.gov.uk

I can’t find the answer to my question. Who should I contact in the MHRA to ask?
You can either e-mail  the Central Enquiry point or telephone on 020 7084 2000.