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Medicines Healthcare Products Regulatory Agency


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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Guidance: How tests and testing kits for coronavirus (COVID 19) work

Guidance: How tests and testing kits for coronavirus (COVID 19) work

The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.

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Detailed guide: Blood: authorisations and safety reporting

Detailed guide: Blood: authorisations and safety reporting

Licences and regulations for organisations that handle human blood or blood products and reporting adverse incidents with blood through SABRE.

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Form: Blood bank compliance report template

Form: Blood bank compliance report template

Template for a blood bank compliance report and guidance on completing it.

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Decision: Orphan registered medicinal products

Decision: Orphan registered medicinal products

A list of authorised orphan medicinal products registered by the UK Licensing Authority.

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Decision: Regulatory approval of COVID 19 Vaccine AstraZeneca

Decision: Regulatory approval of COVID 19 Vaccine AstraZeneca

Information for healthcare professionals and the public about the COVID-19 Vaccine AstraZeneca.

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Detailed guide: Unfettered Access Procedure for marketing authorisations approved in Northern Ireland

Detailed guide: Unfettered Access Procedure for marketing authorisations approved in Northern Ireland

How to apply for the Unfettered Access Procedure (UAP).

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Detailed guide: Decentralised and mutual recognition reliance procedure for marketing authorisations

Detailed guide: Decentralised and mutual recognition reliance procedure for marketing authorisations

How to apply for the decentralised and mutual recognition reliance procedure (MRDCRP).

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Detailed guide: European Commission (EC) Decision Reliance Procedure

Detailed guide: European Commission (EC) Decision Reliance Procedure

How to apply for marketing authorisation via this new procedure.

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Detailed guide: Orphan medicinal products

Detailed guide: Orphan medicinal products

The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.

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Field Safety Notices: 15 to 19 February 2021

Field Safety Notices: 15 to 19 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 February 2021

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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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Decision: Regulatory approval of COVID 19 Vaccine Moderna

Decision: Regulatory approval of COVID 19 Vaccine Moderna

Information for healthcare professionals and the public about the COVID-19 Vaccine Moderna

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Guidance: Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug Coated Balloons and Drug Eluting Stents to the MHRA

Guidance: Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug Coated Balloons and Drug Eluting Stents to the MHRA

The findings and recommendations of the Expert Advisory Group on paclitaxel drug-coated balloon catheters and drug-eluting stents which are used to treat patients with peripheral arterial disease.

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Paclitaxel drug coated balloons (DCBs) or drug eluting stents (DESs): Reconfirmed position on use in patients with intermittent claudication and critical limb ischaemia

Paclitaxel drug coated balloons (DCBs) or drug eluting stents (DESs): Reconfirmed position on use in patients with intermittent claudication and critical limb ischaemia

In February 2020 MHRA reconvened the independent Expert Advisory Group (EAG) to review new evidence. Following the review, the MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia remains unchanged. Do not use paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs) in the routine treatment of patients with intermittent claudication, as the mortality risk generally outweighs the benefits. However, using these devices in patients with critical limb ischaemia remains an option in selected cases, where the benefits may outweigh the risks.

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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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Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury

Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury

The indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Although the temporary suspension has been lifted, this medicine should only be used for intermittent treatment of moderate to severe symptoms of uterine fibroids before menopause and when surgical procedures (including uterine fibroid embolisation) are not suitable or have failed.

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Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury

Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury

The indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Although the temporary suspension has been lifted, this medicine should only be used for intermittent treatment of moderate to severe symptoms of uterine fibroids before menopause and when surgical procedures (including uterine fibroid embolisation) are not suitable or have failed.

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Pregabalin (Lyrica): reports of severe respiratory depression

Pregabalin (Lyrica): reports of severe respiratory depression

Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment; those using concomitant central nervous system (CNS) depressants; and people older than 65 years might be at higher risk of experiencing these events and adjustments in dose or dosing regimen may be necessary.

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Alkindi (hydrocortisone granules): risk of acute adrenal insufficiency in children when switching from hydrocortisone tablet formulations to granules

Alkindi (hydrocortisone granules): risk of acute adrenal insufficiency in children when switching from hydrocortisone tablet formulations to granules

When children receiving replacement therapy for adrenal insufficiency are being switched from hydrocortisone tablets to Alkindi granules, parents or carers should be informed of the need to be extra vigilant for symptoms of adrenal insufficiency.

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Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancy

Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancy

Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.

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Research and analysis: Coronavirus (COVID 19) vaccine adverse reactions

Research and analysis: Coronavirus (COVID 19) vaccine adverse reactions

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

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Detailed guide: Managing clinical trials during Coronavirus (COVID 19)

Detailed guide: Managing clinical trials during Coronavirus (COVID 19)

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

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Class 3 Medicines Recall: SyriMed, Clonidine hydrochloride 50micrograms/5ml Oral Solution, EL (21)A/05

Class 3 Medicines Recall: SyriMed, Clonidine hydrochloride 50micrograms/5ml Oral Solution, EL (21)A/05

SyriMed are recalling the below batch as a precautionary measure due to an issue related to the container closure (child-lock cap).

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Detailed guide: Good clinical practice for clinical trials

Detailed guide: Good clinical practice for clinical trials

How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.

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Class 2 Medicines Recall: Eaststone Limited, MidaBuc Midazolam (as HCL) 10mg/mL Oromucosal Solution, EL (21)A/04

Class 2 Medicines Recall: Eaststone Limited, MidaBuc   Midazolam (as HCL) 10mg/mL Oromucosal Solution, EL (21)A/04

Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled.

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Detailed guide: E cigarettes: regulations for consumer products

Detailed guide: 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: Marketing authorisations granted in 2021

Decision: Marketing authorisations granted in 2021

Marketing authorisations granted in 2021

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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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Field Safety Notices: 8 to 12 February 2021

Field Safety Notices: 8 to 12 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 February 2021

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Research and analysis: Good clinical practice inspection metrics

Research and analysis: Good clinical practice inspection metrics

MHRA good clinical practice (GCP) metrics reports of compliance issues.

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Guidance: How tests and testing kits for coronavirus (COVID 19) work

Guidance: How tests and testing kits for coronavirus (COVID 19) work

The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.

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Decision: Advertising investigations: January 2021

Decision: Advertising investigations: January 2021

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

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Decision: Advertising investigations: December 2020

Decision: Advertising investigations: December 2020

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

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Decision: Advertising investigations: November 2020

Decision: Advertising investigations: November 2020

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

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Decision: Advertising investigations: October 2020

Decision: Advertising investigations: October 2020

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

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Medical device safety information produced by the MHRA

Medical device safety information produced by the MHRA

The MHRA publishes several types of information about medical devices on GOV.UK

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Statutory guidance: MHRA fees

Statutory guidance: MHRA fees

Fees payable to the MHRA for 2020 to 2021

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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

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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Open consultation: Lovima 75 microgram film coated tablets (Desogestrel): Public Consultation

Open consultation: Lovima 75 microgram film coated tablets (Desogestrel): Public Consultation

A 3-week consultation on a proposal to make Lovima 75 microgram film-coated tablets (Desogestrel) available from pharmacies.

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Open consultation: Hana 75 microgram film coated tablets (Desogestrel): Public Consultation

Open consultation: Hana 75 microgram film coated tablets (Desogestrel): Public Consultation

A 3-week public consultation on a proposal to make Hana 75 microgram film-coated tablets (Desogestrel) available from pharmacies.

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Guidance: Assistive technology: definitions, examples and safe use

Guidance: Assistive technology: definitions, examples and safe use

Helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living.

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Guidance: Guidance on applying human factors to medical devices

Guidance: Guidance on applying human factors to medical devices

MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.

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Detailed guide: Valproate use by women and girls

Detailed guide: Valproate use by women and girls

Information about the risks of taking valproate medicines during pregnancy.

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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

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

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