The Medicines and Healthcare products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK.
Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.
The agency has 3 centres:
- The Clinical Practice Research Datalink (CPRD), a data research service that aims to improve public health by using anonymised NHS clinical data.
- The National Institute for Biological Standards and Control (NIBSC), a global leader in the standardisation and control of biological medicines.
- The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator of medicines, medical devices and blood components for transfusion, responsible for ensuring their safety, quality and effectiveness.
The MHRA is an executive agency of the Department of Health.
It employs more than 1,200 people and has facilities in London, York and South Mimms, Hertfordshire.
The agency is responsible for:
- Ensuring that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality, and efficacy.
- Ensuring that the supply chain for medicines, medical devices, and blood components is safe and secure
Promoting international standardisation and harmonisation to assure the effectiveness and safety of biological medicines.
- Helping to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use.
- Supporting innovation and research and development that’s beneficial to public health.
- Influencing UK, EU, and international regulatory frameworks so that they’re risk-proportionate and effective at protecting public health.
Please visit the MHRA website for more details about the agency and what it does, including its latest news:
Classification of medicines
There are 3 ways that medicines can be sold and supplied in the UK:
- On a prescription (referred to as prescription-only medicines (POMs)).
- In a pharmacy without a prescription, under the supervision of a pharmacist (P).
- As a general sale list (GSL) medicine and sold in general retail outlets without the supervision of a pharmacist.
New medicines are usually authorised for use as POMs. After some years’ use, if there is enough evidence to support the safe use of the product without a doctor’s supervision a medicine may be reclassified to P.
Pharmacy medicines which have been safely used for several years may be reclassified as GSL.
Reclassification of a product normally follows a request from the company which holds a marketing authorisation (MA) (product license) for it. However, requests can be made by any interested party, such as a professional body, or be initiated by the Medicines and Healthcare products Regulatory Agency (MHRA).
Rarely, medicines that were previously classified as P are made POM if new risks are identified which need a doctor to ensure the safe use of the medicine.
A GSL medicine may be reclassified as P if new information shows that it is no longer safe to supply it without a pharmacist checking that it is suitable for the patient.
For more information about the classification of medicines and the reclassification process, please see https://www.gov.uk/guidance/medicines-reclassify-your-product.