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Medicines Healthcare Products Regulatory Agency


Convex two piece skin barriers (Natura /Surfit/Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier (MDA/2020/002)

Convex two piece skin barriers (Natura /Surfit/Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier (MDA/2020/002)

Manufactured by ConvaTec – specific batches of convex two-piece skin barriers have been incorrectly manufactured with off-centre starter/stoma hole.

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Guidance: Exporting active substances for medicines after Brexit

Guidance: Exporting active substances for medicines after Brexit

How the ‘Written Confirmation’ process for active substances manufactured in the UK will be handled if there’s a no-deal Brexit.

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NIPPY ventilator range (all models) – update to instructions for use (MDA/2020/001

NIPPY ventilator range (all models) – update to instructions for use (MDA/2020/001

Manufactured by Breas Medical Limited – maintenance schedule now includes changing the internal memory/alarm battery every 3 years.

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Press release: Pharmacist sentenced for supplying drugs on the black market

Press release: Pharmacist sentenced for supplying drugs on the black market

MHRA investigation reveals illegally supplied opiate painkillers, tranquillisers and medications intended for the treatment of cancer worth £280,490.

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Press release: Pharmacist sentenced for supplying drugs on the black market

Press release: Pharmacist sentenced for supplying drugs on the black market

MHRA investigation reveals illegally supplied opiate painkillers, tranquillisers and medications intended for the treatment of cancer worth £280,490.

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Class 4 Medicines Defect Information: Advanz Pharma  Zapain 30mg/500mg Tablets (Codeine Phosphate /Paracetamol), PL12762/0034, (EL(20)A/01)

Class 4 Medicines Defect Information: Advanz Pharma Zapain 30mg/500mg Tablets (Codeine Phosphate /Paracetamol), PL12762/0034, (EL(20)A/01)

Caution in Use: Distribute to Pharmacy level. Advanz Pharma has informed us of a discrepancy on the product packaging. The discrepancy relates to “capsules” printed at the top right of the packs in error, instead of tablets

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Field Safety Notice: 06 to 10 January 2020

Field Safety Notice: 06 to 10 January 2020

List of field safety notices (FSNs) from medical device manufacturers from 06 to 10 January 2020.

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Decision: Marketing authorisations granted in December 2019

Decision: Marketing authorisations granted in December 2019

Marketing authorisations granted in December 2019

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Decision: Marketing authorisations granted in December 2019

Decision: Marketing authorisations granted in December 2019

Marketing authorisations granted in December 2019

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Decision: Parallel import licenses granted in December 2019

Decision: Parallel import licenses granted in December 2019

Parallel import licenses granted in December 2019

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Decision: Parallel import licenses granted in December 2019

Decision: Parallel import licenses granted in December 2019

Parallel import licenses granted in December 2019

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Decision: Early access to medicines scheme (EAMS) scientific opinion: Isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma.

Decision: Early access to medicines scheme (EAMS) scientific opinion: Isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma.

EAMS scientific opinion given to Aventis Pharma in the treatment of adult patients with relapsed and refractory multiple myeloma.

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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: 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: MHRA phase I accreditation scheme

Detailed guide: MHRA phase I accreditation scheme

How to join the phase I accreditation scheme.

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Field Safety Notice: 30 December 2019 to 3 January 2020

Field Safety Notice: 30 December 2019 to 3 January 2020

List of field safety notices (FSNs) from medical device manufacturers from 30 December 2019 to 3 January 2020.

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

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

Department of Health and MHRA register of licensed manufacturing sites - manufacturer specials (human) (MS) and manufacturer specials authorisation (veterinary) (MANSA) only.

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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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Official Statistics: Early access to medicines scheme applications: pending, refused, granted

Official Statistics: Early access to medicines scheme applications: pending, refused, granted

The number of applications pending, refused and granted for the early access to medicines scheme (EAMS).

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Decision: Advertising investigations: November 2019

Decision: Advertising investigations: November 2019

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

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Decision: Advertising investigations: October 2019

Decision: Advertising investigations: October 2019

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

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Decision: Advertising investigations: September 2019

Decision: Advertising investigations: September 2019

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

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Field Safety Notice: 16 to 20 December 2019

Field Safety Notice: 16 to 20 December 2019

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 December 2019.

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Field Safety Notice: 16 to 20 December 2019

Field Safety Notice: 16 to 20 December 2019

List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 December 2019.

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Detailed guide: MHRA phase I accreditation scheme

Detailed guide: MHRA phase I accreditation scheme

How to join the phase I accreditation scheme.

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Detailed guide: Find product information about medicines

Detailed guide: Find product information about medicines

Search for information about medicines including patient information leaflets, details on how the medicine can be used and scientific reports.

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Detailed guide: Find product information about medicines

Detailed guide: Find product information about medicines

Search for information about medicines including patient information leaflets, details on how the medicine can be used and scientific reports.

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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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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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Arrow EZ IO intraosseous vascular access needle sets – risk of needle stick injury

Arrow EZ IO intraosseous vascular access needle sets – risk of needle stick injury

Manufactured by Teleflex Medical (Arrow) – do not use needles if the safety cap is not in place as the risk of needle stick injury is increased and sterility of the needle may be compromised if packaging is punctured.

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Company led drug alert – Paclitaxel 6 mg/ml concentrate for solution for infusion (25ml vials)

Company led drug alert – Paclitaxel 6 mg/ml concentrate for solution for infusion (25ml vials)

Hospira UK Limited (Pfizer) is recalling specific batches as a precautionary measure.

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Guidance: Herbal medicines granted a traditional herbal registration (THR)

Guidance: Herbal medicines granted a traditional herbal registration (THR)

A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).

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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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ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring (MDA/2019/045)

ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring (MDA/2019/045)

Manufactured by GE – central monitoring station or bedside monitor may not provide visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring when used with affected telemetry system.

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Guidance: E learning modules: medicines

Guidance: E learning modules: medicines

E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.

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Guidance: Exporting active substances for medicines after Brexit

Guidance: Exporting active substances for medicines after Brexit

How the ‘Written Confirmation’ process for active substances manufactured in the UK will be handled if there’s a no-deal Brexit.

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