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Medicines Healthcare Products Regulatory Agency


Safety critical alerts are changing at the MHRA

Safety critical alerts are changing at the MHRA

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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Decision: Avelumab in the treatment of bladder cancer

Decision: Avelumab in the treatment of bladder cancer

EAMS scientific opinion issued to Merck Serono Limited for avelumab in the treatment of adults with bladder cancer that has spread beyond the bladder (advanced urothelial carcinoma) if the cancer did not get worse after chemotherapy.

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Decision: Risdiplam in the treatment of type 1 and type 2 spinal muscular atrophy (SMA) in patients 2 months of age and older

Decision: Risdiplam in the treatment of type 1 and type 2 spinal muscular atrophy (SMA) in patients 2 months of age and older

EAMS scientific opinion issued to Roche Products Limited for Risdiplam 0.75 mg/ml powder for oral solution in the treatment of type 1 and type 2 Spinal Muscular Atrophy (SMA) in patients 2 months and older who are not suitable for authorised treatments.

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

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

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

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Class 2 FMD Medicines Recall, Parallel Distributed Medicines, Multiple Products, EL (20)A/45

Class 2 FMD Medicines Recall, Parallel Distributed Medicines, Multiple Products, EL (20)A/45

Medicines from the listed parallel distributors are being recalled due to concerns that the supply chain may have been compromised and the origins of the products are unknown

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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: 7 to 11 September 2020

Field Safety Notices: 7 to 11 September 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 2020.

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Decision: Parallel import licenses granted in August 2020

Decision: Parallel import licenses granted in August 2020

Parallel import licenses granted in August 2020

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Decision: Marketing authorisations granted in August 2020

Decision: Marketing authorisations granted in August 2020

Marketing authorisations granted in August 2020

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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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Detailed guide: Breast implants and Anaplastic Large Cell Lymphoma (ALCL)

Detailed guide: Breast implants and Anaplastic Large Cell Lymphoma (ALCL)

Information for clinicians and patients.

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Class 4 Medicines Defect Information: Zopiclone Tablets, Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan, EL (20)A/44

Class 4 Medicines Defect Information: Zopiclone Tablets, Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan, EL (20)A/44

Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm is missing important safety information related to potential suicide risks

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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

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Field Safety Notices: 1 to 4 September 2020

Field Safety Notices: 1 to 4 September 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 1 to 4 September 2020.

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Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets

Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets

Accord Healthcare Limited is recalling a specific batch of Amlodipine 10mg Tablets as a precautionary measure due to out of specification results obtained during stability testing.

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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 the UK, including the notification scheme and reporting problems with e-cigarettes.

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Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

Pharmacovigilance system requirements from 1 January 2021

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Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

Pharmacovigilance system requirements from 1 January 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: 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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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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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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Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences

Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences

List of companies in the UK who have their licence to manufacture or wholesale medicines terminated and cancelled.

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Decision: Early access to medicines scheme (EAMS) scientific opinion: Avelumab in the treatment of bladder cancer

Decision: Early access to medicines scheme (EAMS) scientific opinion: Avelumab in the treatment of bladder cancer

EAMS scientific opinion issued to Merck Serono Limited for avelumab in the treatment of adults with bladder cancer that has spread beyond the bladder (advanced urothelial carcinoma) if the cancer did not get worse after chemotherapy.

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Decision: Early access to medicines scheme (EAMS) scientific opinion: Avelumab in the treatment of bladder cancer

Decision: Early access to medicines scheme (EAMS) scientific opinion: Avelumab in the treatment of bladder cancer

EAMS scientific opinion issued to Merck Serono Limited for avelumab in the treatment of adults with bladder cancer that has spread beyond the bladder (advanced urothelial carcinoma) if the cancer did not get worse after chemotherapy.

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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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Detailed guide: Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021

Detailed guide: Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021

This guidance sets out how the MHRA will handle centralised applications that are still pending on 1 January 2021.

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Guidance: List of approved countries for authorised human medicines from 1 January 2021

Guidance: List of approved countries for authorised human medicines from 1 January 2021

Approved countries for batch testing and importation of medicines from 1 January 2021

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Detailed guide: Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021

Detailed guide: Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021

The process for applicants applying for a Paediatric Investigation Plan (PIP) waiver from 1 January 2021.

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Detailed guide: Completed Paediatric Studies submission, processing and assessment from 1 January 2021

Detailed guide: Completed Paediatric Studies   submission, processing and assessment from 1 January 2021

Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs) from 1 January 2021

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Detailed guide: Regulating medical devices from 1 January 2021

Detailed guide: Regulating medical devices from 1 January 2021

How medical devices are regulated in the UK will change after the transition period has ended.

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Detailed guide: Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021

Detailed guide: Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021

This guidance sets out how the MHRA will handle centralised applications that are still pending on 1 January 2021.

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Detailed guide: Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021

Detailed guide: Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021

The process for applicants applying for a Paediatric Investigation Plan (PIP) waiver from 1 January 2021.

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Detailed guide: Completed Paediatric Studies submission, processing and assessment from 1 January 2021

Detailed guide: Completed Paediatric Studies   submission, processing and assessment from 1 January 2021

Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs) from 1 January 2021

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Field Safety Notices: 24 28 August 2020

Field Safety Notices: 24   28 August 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 24 August to 28 August 2020.

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Class 2 Medicines Recall: GL Pharma GmbH, Oxylan 40mg prolonged release tablets, EL (20)A/41

Class 2 Medicines Recall: GL Pharma GmbH, Oxylan 40mg prolonged release tablets, EL (20)A/41

GL Pharma is recalling a specific batch of Oxylan 40mg prolonged-release tablets due to out of specification results for dissolution during routine stability testing.

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Statutory guidance: MHRA fees

Statutory guidance: MHRA fees

Fees payable to MHRA for 2020 to 2021

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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

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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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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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Clozapine and other antipsychotics: monitoring blood concentrations for toxicity

Clozapine and other antipsychotics: monitoring blood concentrations for toxicity

Monitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. Blood level monitoring of other antipsychotics for toxicity may also be helpful in certain circumstances, where testing and reference values are available.

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Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment

Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment

Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist review.

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Baricitinib (Olumiant?): increased risk of diverticulitis, particularly in patients with risk factors

Baricitinib (Olumiant?): increased risk of diverticulitis, particularly in patients with risk factors

Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.

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Isotretinoin (Roaccutane?): reminder of important risks and precautions

Isotretinoin (Roaccutane?): reminder of important risks and precautions

We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretinoin should be supervised by specialist dermatologists with a full understanding of the potential risks and monitoring requirements.

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Update: Wockhardt UK Ltd Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection

Update: Wockhardt UK Ltd   Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection

Based on MHRA’s review of available data, the Commission on Human Medicines’ Paediatric Medicine Expert Advisory Group (PMEAG) has advised that Wockhardt UK’s Amoxicillin Sodium Powder for Solution for Injection can be used with caution in neonates and infants.

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