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Medicines Healthcare Products Regulatory Agency


Field Safety Notices: 13 to 17 September 2021

Field Safety Notices: 13 to 17 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 September 2021

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Research: Coronavirus (COVID 19) vaccine adverse reactions

Research: Coronavirus (COVID 19) vaccine adverse reactions

A weekly report covering adverse reactions to approved COVID-19 vaccines

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Press release: Transforming the regulation of software and artificial intelligence as a medical device

Press release: Transforming the regulation of software and artificial intelligence as a medical device

The Medicines and Healthcare products Regulatory Agency (MHRA) is updating regulations applying to software and artificial intelligence (AI) as a medical device.

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Guidance: Software and AI as a Medical Device Change Programme

Guidance: Software and AI as a Medical Device Change Programme

The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI).

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Guidance: Software and AI as a Medical Device Change Programme

Guidance: Software and AI as a Medical Device Change Programme

The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI).

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Press release: MHRA launches public consultation on future of medical device regulation

Press release: MHRA launches public consultation on future of medical device regulation

People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK.

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Open consultation: Consultation on the future regulation of medical devices in the United Kingdom

Open consultation: Consultation on the future regulation of medical devices in the United Kingdom

We're looking for your views on how medical devices will be regulated across the United Kingdom (UK) in the future

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Official Statistics: Medicines: licensing time based performance measures

Official Statistics: Medicines: licensing time based performance measures

Expected time taken to process and grant a marketing authorisation or a variation to a marketing authorisation.

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Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited), IKERVIS 1 mg/mL eye drops, emulsion, EL (21)A/22

Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited), IKERVIS 1 mg/mL eye drops, emulsion, EL (21)A/22

SANTEN Oy (trading as Santen UK Limited) are recalling two batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.

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Decision: Parallel import licences granted in 2021

Decision: Parallel import licences granted in 2021

Parallel import licences granted in 2021

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Decision: Marketing authorisations granted in 2021

Decision: Marketing authorisations granted in 2021

Marketing authorisations granted in 2021

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Guidance: Make a payment to MHRA

Guidance: Make a payment to MHRA

How to make a payment to MHRA by credit or debit card or a bank transfer.

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Guidance: Apply for manufacturer or wholesaler of medicines licences

Guidance: Apply for manufacturer or wholesaler of medicines licences

How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.

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Press release: Long term continual use of topical steroids linked to skin withdrawal side effects

Press release: Long term continual use of topical steroids linked to skin withdrawal side effects

The Medicines and Healthcare products Regulatory Agency (MHRA) is advising anyone experiencing skin redness or burning sensations after they have stopped using these creams or ointments to seek advice from their health professional before using these products again.

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Guidance: Drug Safety Update: monthly PDF newsletter

Guidance: Drug Safety Update: monthly PDF newsletter

Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines.

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Topical corticosteroids: information on the risk of topical steroid withdrawal reactions

Topical corticosteroids: information on the risk of topical steroid withdrawal reactions

Rarely, severe adverse effects can occur on stopping treatment with topical corticosteroids, often after long-term continuous or inappropriate use of moderate to high potency products. To reduce the risks of these events, prescribe the topical corticosteroid of lowest potency needed and ensure patients know how to use it safely and effectively.

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COVID 19 vaccines and medicines: updates for September 2021

COVID 19 vaccines and medicines: updates for September 2021

Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2021 issue of Drug Safety Update, up to 9 September 2021.

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COVID 19 vaccines and medicines: updates for September 2021

COVID 19 vaccines and medicines: updates for September 2021

Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2021 issue of Drug Safety Update, up to 9 September 2021.

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Letters and medicine recalls sent to healthcare professionals in August 2021

Letters and medicine recalls sent to healthcare professionals in August 2021

A summary of recent letters, medicine recalls and notifications sent to healthcare professionals

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MHRA statement on COVID 19 booster vaccines

MHRA statement on COVID 19 booster vaccines

Regulatory updates by the MHRA today on the COVID-19 booster vaccine programme for winter 2021 to 2022

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MHRA statement on COVID 19 booster vaccines

MHRA statement on COVID 19 booster vaccines

Regulatory updates by the MHRA today on the COVID-19 booster vaccine programme for winter 2021 to 2022

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Field Safety Notices: 6 to 10 September 2021

Field Safety Notices: 6 to 10 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 September 2021

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Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film coated tablets (EL (21)A/21)

Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg, 20 mg and 40 mg film coated tablets        (EL (21)A/21)

Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.

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MHRA statement on booster doses of Pfizer and AstraZeneca COVID 19 vaccines

MHRA statement on booster doses of Pfizer and AstraZeneca COVID 19 vaccines

It will be for the JVCI to advise on whether booster jabs will be given and if so, which vaccines should be used.

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Research: Coronavirus (COVID 19) vaccine adverse reactions

Research: Coronavirus (COVID 19) vaccine adverse reactions

A weekly report covering adverse reactions to approved COVID-19 vaccines

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Decision: Regulatory approval of Pfizer/BioNTech vaccine for COVID 19

Decision: Regulatory approval of Pfizer/BioNTech vaccine for COVID 19

Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.

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Decision: Regulatory approval of Vaxzevria (previously COVID 19 Vaccine AstraZeneca)

Decision: Regulatory approval of Vaxzevria (previously COVID 19 Vaccine AstraZeneca)

Information for healthcare professionals and the public about Vaxzevria (previously COVID-19 Vaccine AstraZeneca).

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Guidance: Managing clinical trials during Coronavirus (COVID 19)

Guidance: Managing clinical trials during Coronavirus (COVID 19)

How investigators and sponsors should manage clinical trials during COVID-19

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Guidance: On site access to Electronic Health Records by Sponsor representatives in clinical trials

Guidance: On site access to Electronic Health Records by Sponsor representatives in clinical trials

The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.

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Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

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Field Safety Notices: 30 August to 3 September 2021

Field Safety Notices: 30 August to 3 September 2021

List of field safety notices (FSNs) from medical device manufacturers from 30 August to 3 September 2021.

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Research: Coronavirus (COVID 19) vaccine adverse reactions

Research: Coronavirus (COVID 19) vaccine adverse reactions

A weekly report covering adverse reactions to approved COVID-19 vaccines

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Medical device alerts archived in September 2021

Medical device alerts archived in September 2021

Following our latest review of medical device alerts, we have archived the ones listed below.

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Guidance: E cigarettes: regulations for consumer products

Guidance: E cigarettes: regulations for consumer products

Guidance on how to get an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme and reporting problems with e-cigarettes.

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Decision: Human and veterinary medicines: register of licensed manufacturing sites

Decision: Human and veterinary medicines: register of licensed manufacturing sites

The Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA) register of licensed manufacturing sites - manufacturer specials (human) (MS) and manufacturer specials authorisation (veterinary) (MANSA) only.

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Decision: Human and veterinary medicines: register of licensed wholesale distribution sites

Decision: Human and veterinary medicines: register of licensed wholesale distribution sites

Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human and veterinary).

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Notice: Register of brokers authorised to deal in human medicines

Notice: Register of brokers authorised to deal in human medicines

Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.

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Decision: Medicines: new manufacturing and wholesale dealer licences

Decision: Medicines: new manufacturing and wholesale dealer licences

List of sites granted a manufacturer or wholesale dealer licence

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Press release: Four Non Executive Directors appointed to the Medicines and Healthcare products Regulatory Agency Board

Press release: Four Non Executive Directors appointed to the Medicines and Healthcare products Regulatory Agency Board

Four Non-Executive Directors have been appointed to the board their terms come into effect from 1 September.

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Press release: Four Non Executive Directors appointed to the Medicines and Healthcare products Regulatory Agency Board

Press release: Four Non Executive Directors appointed to the Medicines and Healthcare products Regulatory Agency Board

Four Non-Executive Directors have been appointed to the board their terms come into effect from 1 September.

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Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients

Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients

Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.

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Field Safety Notices: 23 to 27 August 2021

Field Safety Notices: 23 to 27 August 2021

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 August

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Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

Decision: Medical devices given exceptional use authorisations during the COVID 19 pandemic

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

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Decision: Advertising investigations: April 2021

Decision: Advertising investigations: April 2021

Decisions made by MHRA following investigations into complaints about advertising for licensed medicines.

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Decision: Advertising investigations: May 2021

Decision: Advertising investigations: May 2021

Decisions made by MHRA following investigations into complaints about advertising for licensed medicines.

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