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MHRA and making a success of Brexit

The Agency's response to the outcome of the EU referendum.

Following the outcome of the EU referendum, the Medicines and Healthcare products Regulatory Agency (MHRA) is working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.

While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place. Working with our partners, stakeholders and customers, our focus remains: protecting health and improving lives.

Medicines regulation

Playing a full, active role in European regulatory procedures for medicines remains a priority. We contribute significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and reference member state (RMS) appointments, and maintain our programmes for implementing EU legislation as required by our obligations as a Member State. We are also fully engaged in European and national scientific advice services and in delivering our EU inspection-related duties.

Devices regulation

Our role in regulating medical devices and in vitro diagnostic (IVD) devices remains integral. We oversee the essential work of the five UK Notified Bodies; together they are responsible for assessing the majority of devices currently placed on the EU market. Our preparations to implement proposed new Regulations for Medical Devices and IVDs continue.

Vigilance and market surveillance

We maintain our role in vigilance, market surveillance and taking direct action, where needed, to protect patients and public health, and we continue to co-ordinate with other Competent Authorities, across Europe and internationally, in these and other areas.

MHRA will be engaging widely with our stakeholders to fully understand and maximise the opportunities of Brexit.

Statements are also available from the British Pharmacopoeia and the National Institute for Biological Standards and Controls (NIBSC)

Customers, partners and stakeholders approaching MHRA continue to have access to our internationally recognised expertise and we maintain the highest quality services. For further information, please get in touch with your usual contact points in the Agency.