MHRA (Medicines and Healthcare products Regulatory Agency)

Who regulates medicines in the United Kingdom?

In one sentence

The MHRA is the United Kingdom's regulator of medicines, medical devices and blood components for transfusion.

It is an executive agency of the Department of Health and Social Care. Since 1 January 2025 it is the only authority approving medicines for the whole United Kingdom (UK), Northern Ireland included, where the European Union (EU) and its European Medicines Agency (EMA) used to decide.

Where it sits

DepartmentDepartment of Health and Social Care (DHSC)
Executive agencyMedicines and Healthcare products Regulatory Agency
GroupSafety and Surveillance Group
Reporting schemeYellow CardSuspected side effects land here

Think of it like this

A football referee’s yellow card warns a player and goes on the record. The regulator’s Yellow Card does the same for a medicine: one report, logged, and the game is watched more closely from then on.

Key insights

Born of thalidomideOne regulator for the whole UKSuspicion is enoughIt trusts seven other regulators

The Yellow Card scheme was set up in 1964, in the wake of thalidomide, to catch the next disaster early. In 2024/25 it took in about 101,000 suspected reaction reports. Chapter 1 tells the story.

Under the Windsor Framework, since 1 January 2025 licences are UK-wide and an authorisation from the European Commission is no longer valid in Northern Ireland. The EMA lost that role.

You do not have to prove that a medicine caused a reaction to send a Yellow Card; a suspicion is enough. Chapter 2 sets the clock for the cases a company must send on.

Since 1 January 2024 the International Recognition Procedure lets the agency rely on a full assessment by one of seven reference regulators, including the United States Food and Drug Administration (FDA) and the EMA, in 60 or 110 days.

Jump to: 1 Three moments 2 Your report, their clock 3 Side by side with Europe 4 Test yourself

Chapter 1

Which three moments made the MHRA what it is?

Pick a year. Each one changed what a company in the UK has to do.

1964A card for suspicions2024Trusting other regulators2025One licence for the whole UK

A card for suspicions

In 1964, in the wake of thalidomide, the UK set up the Yellow Card scheme to collect suspected adverse drug reactions as an early warning of possible hazards. Health professionals, patients and carers report voluntarily, alongside the reports collected from industry.

The bar was set low and has stayed there: you do not have to prove causality to report, only a suspicion is needed.

What it left behind: a reporting culture that fed about 101,000 suspected reaction reports into the agency in 2024/25.

Trusting other regulators

On 1 January 2024 the International Recognition Procedure opened. A company that already holds an approval from one of seven reference regulators, among them the FDA, the EMA and Health Canada, can ask the MHRA to recognise it.

The reference approval must have come from a full, standalone review. Recognition A runs on a 60-day timetable with no clock stop; Recognition B takes 110 days with one.

What it left behind: a UK route whose speed depends on the quality of someone else’s assessment report.

One licence for the whole UK

After Brexit, novel medicines for Northern Ireland were still approved by the EMA and the European Commission, so a company needed separate licences and packs for Great Britain and Northern Ireland.

The Windsor Framework ended that. From 1 January 2025 the MHRA is the only authority approving medicines for the UK market, under one Product Licence, and a Commission authorisation is no longer valid in Northern Ireland. Category 2 medicines keep some EU rules, so Northern Ireland keeps access to both markets.

What it left behind: one licence, one pack, and for Category 2 products one case sent to two databases.

Chapter 2

Your report, their clock

A case has reached your company. In the Human Medicines Regulations 2012 two questions set the deadline for a suspected adverse drug reaction (ADR): is it serious, and did it happen in the UK? Pick a cell.

In the UKOutside the UKSeriousSerious, in the UKSerious, outside the UKNot seriousNot serious, in the UKNot serious, outside the UK

Or the case came another way: serious, on a Category 2 product in Northern Ireland or in a trial, fatal or life-threatening and unexpected

Every serious suspected reaction, wherever it happened, goes to the licensing authority within 15 days of the day you learned of it, through the MHRA Gateway or the agency’s case report portal. Regulation 188(1)(a)

A non-serious suspected reaction in the UK goes in within 90 days. Follow-up on a serious case has its own 15-day clock. Regulation 188(1)(b)

No submission to the MHRA is required for a non-serious case outside the UK. You still record it: every suspected reaction, in the UK or another country, must be on file and accessible at a single point in the UK. Regulation 187(1) and (4)

Serious reactions on a product authorised for Northern Ireland under Category 2 go to the MHRA and, within the same 15 days, to EudraVigilance, the EU database, with the country code XI. Regulation 188(1A)

A fatal or life-threatening suspected unexpected serious adverse reaction in a UK trial reaches the licensing authority within 7 days of the sponsor learning of it, with any further information within 8 more days; other such reactions within 15 days. Clinical Trials Regulations 2004, regulation 33

You do not have to prove causality to report a suspected ADR, only a suspicion is needed.
The agency’s Yellow Card guidance for healthcare professionals, patients and the public

Inspectors check that the clocks are kept: in the year to March 2022 the agency’s Good Pharmacovigilance Practice team ran 32 inspections and graded six findings critical, one of them for the submission of periodic safety update reports.

Chapter 3

Side by side with Europe

Five things a company feels the difference in since the UK left the EU network in 2021.

	United Kingdom	European Union
Who signs the approval	The MHRA, for the whole UK since 1 January 2025	The European Commission, on the EMA’s opinion
Where company reports go	The MHRA Gateway or its case report portal; Category 2 products also to EudraVigilance	EudraVigilance, run by the EMA with the Member States
Who inspects you	The MHRA’s Good Pharmacovigilance Practice team	Your national competent authority, with the EMA
The qualified person	Resident in the UK or the EU; a UK contact person if the qualified person sits abroad	Permanently and continuously at the company’s disposal
Periodic safety update reports	To the MHRA portal, on the EU reference date list; Category 2 products through the EU repository	To the EMA, through the EU repository

Show the legal references

Approval: MHRA Windsor Framework explainer (“from 1 January 2025, the MHRA will be the only authority approving medicines for the UK market”); Regulation (EC) No 726/2004, Article 10(1).
Reports: Human Medicines Regulations 2012, regulation 188(1) and (1A); the MHRA guidance on pharmacovigilance procedures, section 3; Regulation 726/2004, Article 24(1).
Inspections: Pharmacovigilance Inspection Metrics Report, April 2021 to March 2022; Directive 2001/83/EC, Article 111(1).
Qualified person: regulation 182(2)(a) and (2A); Directive 2001/83/EC, Article 104(3)(a).
Periodic safety update reports: regulation 191(1) and the guidance on pharmacovigilance procedures, section 5; Directive 2001/83/EC, Article 107b(1).

One island, two rule books: Great Britain follows UK law alone, while a Category 2 medicine in Northern Ireland keeps some EU obligations and reports to both the MHRA and EudraVigilance.

The facts, in one place

What it is	An executive agency of the Department of Health and Social Care, acting as the licensing authority under the Human Medicines Regulations 2012.
Since	2003, taking over from the Medicines Control Agency; merged with the National Institute for Biological Standards and Control on 1 April 2013.
Who decides	The chief executive and executive committee; the board takes no regulatory decisions. The Commission on Human Medicines advises on safety, efficacy and quality.
Seat	Canary Wharf, London, with a Science Campus at South Mimms.
Money and people	£158.5 million of trading income in 2024/25, £46.8 million of it vigilance fees on licence holders; 1,553 staff. Most running costs come from industry.
Safety group	The Safety and Surveillance Group, led by a Chief Safety Officer: about 101,000 reports assessed and 146 signals identified in 2024/25.
Member of	The International Council for Harmonisation (ICH), as a regulatory member; the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 1999; the International Coalition of Medicines Regulatory Authorities (ICMRA).

Don’t confuse it with: the National Institute for Health and Care Excellence (NICE)

MHRA

Is it safe, effective and of good quality?

Decides: whether a medicine may be sold in the UK
Watches: safety after licensing, through Yellow Cards and inspections
Example: adds a warning to the product information

NICE

Is it worth the health service paying for?

Produces: guidance for the National Health Service (NHS), including technology appraisals
Weighs: value for the taxpayer
Example: recommends whether the NHS should fund a licensed medicine

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“You should only send a Yellow Card once you are sure the medicine caused the reaction.”

MythTruth

MythYou got it.Not quite.

The agency’s own guidance says you do not have to prove causality; a suspicion is enough. Waiting for certainty is how early warnings get lost.

“Since 1 January 2025 an EU centralised authorisation is no longer valid in Northern Ireland.”