Guidance

More information about the MHRA

Published 16 January 2023

Medicines and vaccines

The MHRA regulates medicines, including vaccines, supplied in the UK. Our activity spans the whole of a medicine’s lifecycle. We decide whether medicines should be granted licences (also known as Marketing Authorisations) and whether licences can be varied as information about the medicines develop. These decisions are based on safety, quality and effectiveness data submitted to us.

A medicine that is granted a licence does not necessarily become immediately available to patients in the UK. The Department of Health and Social Care make decisions on which medicines should be purchased for the UK, and the National Institute of Clinical Excellence decide whether or not medicines should be made available on the NHS. These organisations are able to consider wider factors in their decision-making, including the need for the medicine in the UK given the circumstances at that time. We also carry out a number of regulatory activities before and after a licence is granted and for unlicensed medicines, some of which are summarised below.

• Inspecting facilities that manufacture and carry out safety tests on medicines to ensure they comply with Good Manufacturing Practice and Good Laboratory Practice standards.
• Approving UK-based clinical trials and inspect them to ensure they comply with Good Clinical Practice standards.
• Carrying out vital research to support the development of new biological medicines and vaccines
• Developing reference materials for biological medicines to ensure their quality can be assessed in a standard way
• Monitoring the safety of the medicine while on the market, for example by actively assessing Yellow Card reports submitted to us
• Reclassifying existing medicines (for example from a Prescription Only Medicine to Over The Counter), if there is evidence to safely support doing so
• Regulating the importation of licensed medicines to the UK from other EU countries.
• Carrying out inspections to ensure that medicines are developed, manufactured, distributed and monitored to internationally recognised standards.
• Helping set and enforce the legal advertising regulations for medicines in the UK
• Independent Quality testing of batches of biological medicines before they go onto the market to make sure that it is consistent with batches previously shown to be safe and effective

For unlicensed medicines, we:

• Regulate the supply of unlicensed medicines into the UK, for example as “specials”.
• Carry out enforcement activities to prevent the illegal supply of unlicensed medicines, to or within the UK.

Medical devices

The MHRA is responsible for operating the UK medical device vigilance system. This includes carrying out market surveillance, enforcing the legislation and working in collaboration with healthcare and regulatory stakeholders both in the UK and worldwide.

Before a medical device can be placed on the UK market it must have a UKCA or CE certificate. This certificate shows that the device meets the relevant regulations. For higher risk devices (Class II, IIb or III), this certificate must be issued by an independent “UK Approved body”. Low risk devices (Class I) do not need to go through a UK Approved body and the manufacturer can self-certify the product before placing it on the market.

While we don’t certify medical devices, we do have oversight of UK Approved bodies and have powers to remove medical devices from the UK market if we feel they are unsafe.

In exceptional circumstances, we can issue Exceptional Use Authorisations (EUAs) allowing medical devices to be used that have not followed the standard approval process.

Individuals and manufacturers can register their devices with us, but this does not equate to an “approval” or certification.

Blood components

The MHRA is responsible for the controls and authorisations that apply to blood establishments – this can be any site where blood is collected and tested, such as in public buildings like schools or town halls.

We also manage the controls that apply to hospital blood banks and any other sites that collect, test, and supply human blood or blood components intended for transfusion.

We inspect all locations that have requested blood establishment authorisation, and we collect application fees for these site authorisations.

Inspections of blood establishments are carried out by us at least once every two years. The frequency of inspections depends on the level of risk, which is determined by the results of annual compliance reports and the number of adverse events that we receive and then review. We also collect forms from hospital blood banks about any closures. Blood establishments and hospital blood banks are individually responsible for reporting serious adverse events and reactions relating to blood to us via our Serious Adverse Blood Reactions and Events reporting platform.

E-cigarettes

To be legally sold in the UK, nicotine-containing e-cigarettes must be compliant with the Tobacco and Related Products Regulations 2016 (TRPR) and therefore meet the standards required for supply in the UK and EU.

Under the TRPR, manufacturers must “notify” the MHRA of their product before they can supply it on the UK market. Our role doesn’t involve ‘approving’ these products – we only ensure that they are compliant with the TRPR.

The compliance of e-cigarette products is published on our website. We work collaboratively with regional and national UK enforcement agencies and trade bodies to help identify and remove illicit products from the UK market. Where appropriate we will assist manufacturers in ensuring regulatory compliance.

We have also published guidance on the standards products need to reach to obtain a licence for use as a smoking cessation aid.

Nicotine-free e-cigarette products are not covered by the TRPR and do not come under the remit of the UK notification requirement. These products are subject to the product safety requirements of the General Product Safety Regulations enforced by Trading Standards.

For more information, see our advice to consumers which includes a link to data for all suspected side effects that have been reported to the MHRA via the Yellow Card scheme involving a nicotine-containing e-cigarette.

Herbal and homeopathic medicines

At the MHRA, we determine whether a submitted product is a herbal medicine. The active ingredients must be herbal substances and/or herbal preparations only. We provide guidance on how manufacturers can apply for traditional herbal registration (THR) to market their herbal medicine in the UK. We only grant a THR if the medicine is used for minor health conditions where medical supervision is not required, such as a cold.

We are also responsible for providing market authorisations for traditional herbal medicinal products claiming to treat major health conditions.

Homeopathy is a system of medicine which involves treating the individual with diluted substances, given mainly in tablet form. Like with herbal medicines, you can register your homeopathic medicine with us, but this does not mean that we give you any form of accreditation, certification, or approval for the homeopathic medicine.

We are responsible for reviewing homeopathic application forms with the required documents through MHRA submissions before official registration is complete.