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Medicines and Healthcare products Regulatory Agency

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First Innovation Passport awarded to help support development and access to cutting edge medicines

First Innovation Passport awarded to help support development and access to cutting edge medicines

Friday, 26 February 2021

The Innovative Licensing and Access Pathway (ILAP) aims to reduce the time to market for innovative medicines...

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Views sought on making the oral contraceptive pill desogestrel available from pharmacies

Views sought on making the oral contraceptive pill desogestrel available from pharmacies

Friday, 12 February 2021

The public has until 5 March to respond to the consultation on the potential reclassification of desogestrel to a pharmacy medicine.  ...

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New partnership pledges clear and consistent evidence based guidance on medicines for pregnant and breastfeeding women

New partnership pledges clear and consistent evidence based guidance on medicines for pregnant and breastfeeding women

Thursday, 11 February 2021

The Consortium brings together 16 leading organisations, spanning the NHS, regulators, and leading third sector and charitable organisations...

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Latest monitoring data confirms safety of COVID 19 vaccines

Latest monitoring data confirms safety of COVID 19 vaccines

Friday, 05 February 2021

Data published from UK’s independent medicines regulator confirms approved vaccines meet strict regulatory standards for safety...

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Independent batch release testing of COVID 19 (coronavirus) vaccines by the NIBSC

Independent batch release testing of COVID 19 (coronavirus) vaccines by the NIBSC

Friday, 08 January 2021

The National Institute for Biological Standards and Control will carry out independent testing in the UK for any potential COVID-19 vaccines....

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Moderna vaccine becomes third COVID 19 vaccine approved by UK regulator

Moderna vaccine becomes third COVID 19 vaccine approved by UK regulator

Friday, 08 January 2021

The vaccine has been approved after meeting the required safety, quality and effectiveness standards....

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Access Consortium regulators pledge support to tackle COVID 19

Access Consortium regulators pledge support to tackle COVID 19

Thursday, 07 January 2021

The Access Consortium regulatory authorities have pledged our collective support in countering the COVID-19 global pandemic....

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Safety review of epilepsy medicines in pregnancy   women who may become pregnant urged to discuss treatment options with their doctor

Safety review of epilepsy medicines in pregnancy women who may become pregnant urged to discuss treatment options with their doctor

Thursday, 07 January 2021

Women receiving treatment for epilepsy are being urged to discuss with a healthcare professional the right treatment for them if they anticipate ...

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The MHRA Innovative Licensing and Access Pathway is open for business

The MHRA Innovative Licensing and Access Pathway is open for business

Friday, 01 January 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) today, 1 January 2021, formally starts the Innovative Licensing and Access Pathway (ILA...

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Oxford University/AstraZeneca COVID 19 vaccine approved

Oxford University/AstraZeneca COVID 19 vaccine approved

Wednesday, 30 December 2020

The new vaccine has been approved after meeting the required safety, quality and effectiveness standards....

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MHRA issues exceptional use authorisation for NHS Test and Trace COVID 19 Self Test device

MHRA issues exceptional use authorisation for NHS Test and Trace COVID 19 Self Test device

Wednesday, 23 December 2020

An application for exceptional use of a COVID-19 rapid test, to be used by members of the public, has today been approved by the Medicines and Healthc...

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June Raine: How we backed a COVID 19 vaccine before rest of the West

June Raine: How we backed a COVID 19 vaccine before rest of the West

Tuesday, 08 December 2020

MHRA Chief Executive Dr June Raine explains the process behind the Agency's approval of the Pfizer/BioNTech vaccine...

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UK medicines regulator gives approval for first UK COVID 19 vaccine

UK medicines regulator gives approval for first UK COVID 19 vaccine

Wednesday, 02 December 2020

The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by ...

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Oxford/AstraZeneca COVID 19 vaccine: MHRA statement confirming letter received

Oxford/AstraZeneca COVID 19 vaccine: MHRA statement confirming letter received

Friday, 27 November 2020

The safety of the public will always come first. ...

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Pfizer/BioNTech COVID 19 vaccine: MHRA statement confirming data received

Pfizer/BioNTech COVID 19 vaccine: MHRA statement confirming data received

Monday, 23 November 2020

Safety is our watch word. ...

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Pfizer/BioNTech COVID 19 vaccine: MHRA statement

Pfizer/BioNTech COVID 19 vaccine: MHRA statement

Monday, 23 November 2020

The safety of the public will always come first. ...

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Sleep disorder drug modafinil linked to increased risk of birth defects and also to reduced effectiveness of contraception

Sleep disorder drug modafinil linked to increased risk of birth defects and also to reduced effectiveness of contraception

Monday, 16 November 2020

Women using modafinil are being warned of an increased risk of birth defects associated with modafinil use during pregnancy. ...

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Isotretinoin and suspected link with serious side effects: public and patients’ views sought

Isotretinoin and suspected link with serious side effects: public and patients’ views sought

Tuesday, 10 November 2020

We are reviewing the risks and benefits of the acne medicine, isotretinoin. In particular whether some of the possible psychiatric and sexual side eff...

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Milestone 1 million Yellow Card report for suspected side effects in #MedSafetyWeek

Milestone 1 million Yellow Card report for suspected side effects in #MedSafetyWeek

Monday, 02 November 2020

The Yellow Card scheme is the UK’s system for reporting suspected side effects to medicines and adverse events with medical devices run by the Medicin...

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MHRA collaborates to disband international crime network

MHRA collaborates to disband international crime network

Sunday, 01 November 2020

The MHRA’s Enforcement Group, working in collaboration with German law enforcement partners, has helped to dismantle a global criminal network involve...

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Thermometer recall: Safe and Sound Infrared Ear Thermometer   MHRA urges people to check theirs for recalled lots

Thermometer recall: Safe and Sound Infrared Ear Thermometer MHRA urges people to check theirs for recalled lots

Friday, 30 October 2020

Users of Safe and Sound Infrared Ear Thermometers are being urged by the MHRA to check their product code and lot number due to a voluntary product re...

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Flublok vaccine given authorisation for temporary supply in the UK to meet public health need

Flublok vaccine given authorisation for temporary supply in the UK to meet public health need

Thursday, 22 October 2020

US-licensed flu vaccine (Flublok) to be used as part of the UK’s 2020/21 seasonal flu programme...

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NIBSC selected by CEPI to test coronavirus vaccines globally

NIBSC selected by CEPI to test coronavirus vaccines globally

Tuesday, 20 October 2020

The National Institute for Biological Standards and Control (NIBSC) will play a key role in evaluating vaccines that have been developed for COVID-19...

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UK medicines regulator joins up with Australia, Canada, Singapore and Switzerland regulators

UK medicines regulator joins up with Australia, Canada, Singapore and Switzerland regulators

Wednesday, 14 October 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Conso...

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Warfarin and other blood thinners – reminder on safe use during COVID 19 pandemic

Warfarin and other blood thinners – reminder on safe use during COVID 19 pandemic

Tuesday, 13 October 2020

The MHRA has published advice for patients and healthcare professionals ...

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UK regulator strengthens opioid warnings

UK regulator strengthens opioid warnings

Wednesday, 23 September 2020

Stronger warnings about the risk of dependence and addiction to be added to the patient information leaflet and discussed with patients ...

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Safety critical alerts are changing at the MHRA

Safety critical alerts are changing at the MHRA

Thursday, 17 September 2020

The MHRA will now issue all safety-critical alerts for medicines and medical devices that require action as National Patient Safety Alerts...

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One pharmacist’s report helps safer use of inhalers in the UK

One pharmacist’s report helps safer use of inhalers in the UK

Thursday, 17 September 2020

Reporting suspected side effects or incidents to the Yellow Card scheme supports the safe use of medical products for everyone ...

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Stephen Lightfoot to become Chair

Stephen Lightfoot to become Chair

Monday, 24 August 2020

Stephen Lightfoot will become Chair of the Medicines and Healthcare products Regulatory Agency (MHRA) from 1 September 2020....

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New restrictions introduced on sales of stimulant laxatives to counter risks from overuse

New restrictions introduced on sales of stimulant laxatives to counter risks from overuse

Tuesday, 18 August 2020

People who take stimulant laxatives for constipation are being advised that these will now be sold in smaller packs, with on-pack warnings. ...

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