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Medicines and Healthcare products Regulatory Agency

783 articles

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Anyone with Prenoxad (naloxone) injection kits must check for missing needles

Anyone with Prenoxad (naloxone) injection kits must check for missing needles

Thursday, 10 November 2022

Patients, carers and healthcare professionals with kits of the opioid overdose medicine Prenoxad Injection must visually check for the presence of two...

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Second Pfizer/BioNTech bivalent COVID 19 booster vaccine approved by UK medicines regulator

Second Pfizer/BioNTech bivalent COVID 19 booster vaccine approved by UK medicines regulator

Wednesday, 09 November 2022

This adapted COVID-19 vaccine targets both the original virus and the Omicron BA.4 and BA.5 sub-variants....

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Every report to MHRA’s Yellow Card scheme helps improve the safety of medicines and medical devices for all

Every report to MHRA’s Yellow Card scheme helps improve the safety of medicines and medical devices for all

Monday, 07 November 2022

To improve medical product safety for all, report suspected side effects and adverse incidents as part of the #MedSafetyWeek global campaign...

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Patients urged to check packs of Targocid 200mg after two batches found to be contaminated

Patients urged to check packs of Targocid 200mg after two batches found to be contaminated

Friday, 21 October 2022

Patients using antibiotic Targocid 200mg powder at home must check if the batch number of their medicine is 0J25D1 or 0J25D2. Anyone who has one of th...

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London medicines wholesaler sentenced for illegally importing and distributing over £2.9m of medicines

London medicines wholesaler sentenced for illegally importing and distributing over £2.9m of medicines

Wednesday, 19 October 2022

The owner of a medicines wholesale business was sentenced yesterday at Southwark Crown Court to 20 weeks imprisonment, suspended for 12 months and com...

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Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems

Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems

Thursday, 13 October 2022

Healthcare professionals asked to share their views on how they want to receive safety information from the UK medicines and medical devices regulator...

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Mental health funding of £1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools

Mental health funding of £1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools

Monday, 10 October 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have been awarded £1.8...

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MHRA response to contaminated paediatric medicines identified in WHO region of Africa

MHRA response to contaminated paediatric medicines identified in WHO region of Africa

Friday, 07 October 2022

The safety of the medicines you and your children take is our highest priority ...

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European Commission Decision Reliance Procedure (EC DRP) extension

European Commission Decision Reliance Procedure (EC DRP) extension

Friday, 30 September 2022

European Commission Decision Reliance Procedure (ECDRP) now continues to be available until 31 December 2023....

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MHRA appoints first new UK Approved Body to certify medical devices since Brexit

MHRA appoints first new UK Approved Body to certify medical devices since Brexit

Thursday, 29 September 2022

DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies...

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MHRA launches new conflicts of interest code of practice for independent advisors

MHRA launches new conflicts of interest code of practice for independent advisors

Thursday, 08 September 2022

The MHRA is introducing a new, single code of practice for all its scientific advisory committees....

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No change to MHRA advice on the safety and effectiveness of COVID 19 vaccines for those who are pregnant or breastfeeding

No change to MHRA advice on the safety and effectiveness of COVID 19 vaccines for those who are pregnant or breastfeeding

Monday, 05 September 2022

Our advice remains that the COVID-19 vaccines are safe and effective during pregnancy and breastfeeding ...

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Pfizer/BioNTech bivalent COVID 19 booster approved by UK medicines regulator

Pfizer/BioNTech bivalent COVID 19 booster approved by UK medicines regulator

Saturday, 03 September 2022

The adapted COVID-19 vaccine targets both the original virus and the Omicron variant...

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Novavax COVID 19 vaccine approved for 12 to 17s by MHRA

Novavax COVID 19 vaccine approved for 12 to 17s by MHRA

Friday, 26 August 2022

The Medicines and Healthcare products Regulatory Agency has concluded that Nuvaxovid is safe and effective in this age group...

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First bivalent COVID 19 booster vaccine approved by UK medicines regulator

First bivalent COVID 19 booster vaccine approved by UK medicines regulator

Monday, 15 August 2022

The adapted COVID-19 vaccine made by Moderna targets two different coronavirus variants: the original virus from 2020 and the Omicron variant ...

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MHRA and CAP take action against illegal ‘hayfever jab’ adverts online

MHRA and CAP take action against illegal ‘hayfever jab’ adverts online

Thursday, 04 August 2022

A joint enforcement notice warns all organisations offering Kenalog as a hayfever treatment to stop advertising it on social media or website advertis...

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Safety review to begin on topiramate

Safety review to begin on topiramate

Wednesday, 20 July 2022

Information about a review into the safety of topiramate, which will look at possible harms in the learning and development of children whose mothers ...

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Over 285,000 medicines and medical devices seized UK wide in global action

Over 285,000 medicines and medical devices seized UK wide in global action

Wednesday, 20 July 2022

Officers from the MHRA have seized large quantities of illegally traded medicines and medical devices in an Interpol week of action known as "Operatio...

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Easier access to locally applied HRT to treat postmenopausal vaginal symptoms in landmark MHRA reclassification

Easier access to locally applied HRT to treat postmenopausal vaginal symptoms in landmark MHRA reclassification

Wednesday, 20 July 2022

From September, women in the UK will be able to buy Gina 10 microgram vaginal tablets without a prescription...

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UK to strengthen regulation of medical devices to protect patients

UK to strengthen regulation of medical devices to protect patients

Saturday, 25 June 2022

New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published....

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MHRA joins international partnerships to set global standards for medicines and medical devices regulation

MHRA joins international partnerships to set global standards for medicines and medical devices regulation

Thursday, 16 June 2022

These are the International Medical Device Regulatory Forum, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals...

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New safety warnings on risk of insulin leakage from Roche Accu Chek Insight Insulin pumps

New safety warnings on risk of insulin leakage from Roche Accu Chek Insight Insulin pumps

Thursday, 26 May 2022

The UK regulator has taken safety action to reduce risks associated with Roche Accu-Chek Insight Insulin Pumps by issuing a national safety alert and ...

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MHRA approves faricimab through international work sharing initiative

MHRA approves faricimab through international work sharing initiative

Tuesday, 17 May 2022

It is the first treatment approved by the UK regulator that has been made possible through the Access Consortium ‘New Active Substance Work Sharing In...

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Share your views on making a treatment for overactive bladder available for women without need for prescription

Share your views on making a treatment for overactive bladder available for women without need for prescription

Friday, 22 April 2022

The Medicines and Healthcare products Regulatory Agency is calling for women who experience symptoms associated with overactive bladder such as the ur...

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MHRA approves the Moderna COVID 19 vaccine ‘Spikevax’ for use in 6 to 11 year olds

MHRA approves the Moderna COVID 19 vaccine ‘Spikevax’ for use in 6 to 11 year olds

Thursday, 14 April 2022

Use of the Moderna COVID-19 vaccine or ‘Spikevax’ has been approved for 6 to 11s after meeting the required safety, quality and effectiveness standard...

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Valneva COVID 19 vaccine approved by MHRA

Valneva COVID 19 vaccine approved by MHRA

Thursday, 14 April 2022

An approval has been granted after the Valneva COVID-19 vaccine was found to meet the required safety, quality and effectiveness standards....

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The MHRA are seeking views to strengthen conflicts of interest policy for independent advisors

The MHRA are seeking views to strengthen conflicts of interest policy for independent advisors

Tuesday, 12 April 2022

Stakeholders and the UK public are invited to have their say on how the Medicines and Healthcare products Regulatory Agency (MHRA) manages the conflic...

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Evusheld approved to prevent COVID 19 in people whose immune response is poor

Evusheld approved to prevent COVID 19 in people whose immune response is poor

Thursday, 17 March 2022

The decision to grant approval for this treatment was endorsed by the government’s independent expert scientific advisory body, the Commission on Huma...

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Health and social care leaders unite to improve public involvement in research

Health and social care leaders unite to improve public involvement in research

Friday, 11 March 2022

The MHRA, NIHR, HRA and other organisations across the UK are working together to bring about changes which will drive up standards in health and soci...

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Pharmaceutical company fined for manufacturing defective medicine

Pharmaceutical company fined for manufacturing defective medicine

Wednesday, 02 March 2022

Syri Ltd has been fined £51,000 and ordered to pay costs of £104,898 by Aylesbury Crown Court. ...

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