GovWire

Medicines Healthcare Products Regulatory Agency


Welcome new MHRA senior appointments

Welcome new MHRA senior appointments

The Medicines and Healthcare products Regulatory Agency (MHRA) is welcoming two directors.

0 comments Read Full Article
Graeme Tunbridge appointed interim Director of Devices

Graeme Tunbridge appointed interim Director of Devices

The MHRA’s new interim Director of Devices will take up his post on 21 October

0 comments Read Full Article
Ingenol mebutate gel (Picato?): increased incidence of skin tumours seen in some clinical studies

Ingenol mebutate gel (Picato?): increased incidence of skin tumours seen in some clinical studies

Advise patients treated with ingenol mebutate gel to be vigilant for new skin lesions and to seek medical advice immediately should any occur. Use with caution in patients with a history of skin cancer.

0 comments Read Full Article
Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation

Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation

Patients on nivolumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infections such as cytomegalovirus (CMV).

0 comments Read Full Article
Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions

Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactions

For most patients and most medicines, estimated Glomerular Filtration Rate (eGFR) is an appropriate measure of renal function for determining dosage adjustments in renal impairment; however, in some circumstances, the Cockcroft-Gault formula should be used to calculate creatinine clearance (CrCl).

0 comments Read Full Article
Adrenaline auto injectors: recent action taken to support safety

Adrenaline auto injectors: recent action taken to support safety

Healthcare professionals should be aware of alerts and letters issued about adrenaline auto-injectors in September and October 2019. This article provides a summary of recent advice issued to healthcare professionals, including information to provide to patients, to support safe use of adrenaline auto-injectors.

0 comments Read Full Article
Letters and drug alerts sent to healthcare professionals in September 2019

Letters and drug alerts sent to healthcare professionals in September 2019

Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod. Recall alerts were recently issued about ranitidine, aripiprazole, and bisacodyl.

0 comments Read Full Article
Press release: Ranitidine – MHRA drug alert issued for Teva UK recall

Press release: Ranitidine – MHRA drug alert issued for Teva UK recall

Teva UK Ltd is recalling unexpired stock of certain batches of 2 types of Ranitidine medicines used to treat conditions such as heartburn and stomach ulcers.

0 comments Read Full Article
Class 2 Medicines recall: Ranitidine Effervescent Tablets 150mg, Ranitidine Effervescent Tablets 300mg (EL (19)A/27)

Class 2 Medicines recall: Ranitidine Effervescent Tablets 150mg, Ranitidine Effervescent Tablets 300mg (EL (19)A/27)

Teva UK Limited trading as ratiopharm GmbH is recalling all unexpired stock of Ranitidine Effervescent Tablets from pharmacies.

0 comments Read Full Article
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).

0 comments Read Full Article
Decision: Parallel import licenses granted in September 2019

Decision: Parallel import licenses granted in September 2019

Parallel import licenses granted in September 2019

0 comments Read Full Article
Decision: Marketing authorisations granted in September 2019

Decision: Marketing authorisations granted in September 2019

Marketing authorisations granted in September 2019

0 comments Read Full Article
Class 4 Medicines Defect Information: Xonvea 10 mg/10 mg gastro resistant tablets (MDR  025 10/19)

Class 4 Medicines Defect Information: Xonvea 10 mg/10 mg gastro resistant tablets (MDR 025 10/19)

Alliance Pharmaceuticals Ltd has informed the MHRA that there are possible side effects not reported on the Patient Information Leaflet.

0 comments Read Full Article
Class 4 Medicines Defect Information: Rifadin (rifampicin) 150mg Capsules (MDR  127 09/19)

Class 4 Medicines Defect Information: Rifadin (rifampicin) 150mg Capsules (MDR 127 09/19)

Aventis Pharma Limited t/a Sanofi has informed the MHRA that a change to the Patient Information Leaflet concerning possible side effects for Rifadin (rifampicin) 150mg Capsules has not been implemented by the required timeline.

0 comments Read Full Article
Detailed guide: Decide if your product is a medicine or a medical device

Detailed guide: Decide if your product is a medicine or a medical device

How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products).

0 comments Read Full Article
Decision: Advertising investigations: August 2019

Decision: Advertising investigations: August 2019

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

0 comments Read Full Article
Field Safety Notice: 7 October to 11 October

Field Safety Notice: 7 October to 11 October

List of field safety notices (FSNs) from medical device manufacturers from 7 October to 11 October

0 comments Read Full Article

Field Safety Notice: 7 October to 11 October

Field Safety Notice: 7 October to 11 October

List of field safety notices (FSNs) from medical device manufacturers from 7 October to 11 October

0 comments Read Full Article

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.

0 comments Read Full Article

Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no deal Brexit

Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no deal Brexit

Pharmacovigilance system requirements if there is a no-deal Brexit.

0 comments Read Full Article

Press release: Life Sciences and UK's future role: Sir John Bell delivers MHRA annual lecture

Press release: Life Sciences and UK's future role: Sir John Bell delivers MHRA annual lecture

The UK has a unique opportunity to lead the field in Life Sciences, with an exciting and important role for the MHRA.

0 comments Read Full Article

Guidance: Importing investigational medicinal products from approved countries after Brexit

Guidance: Importing investigational medicinal products from approved countries after Brexit

Importing investigational medicinal products for use in clinical trials if there's a no-deal Brexit.

0 comments Read Full Article

Detailed guide: How the MHRA will manage UK orphan medicinal products after Brexit

Detailed guide: How the MHRA will manage UK orphan medicinal products after Brexit

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

0 comments Read Full Article

Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment (MDA/2019/037)

Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment (MDA/2019/037)

Manufactured by Baxter – Communication error alarms may result in unintentional delay and interruption of treatment due to system shutdown.

0 comments Read Full Article

Detailed guide: How Marketing Authorisation Applications referred under Article 29 will be handled after Brexit

Detailed guide: How Marketing Authorisation Applications referred under Article 29 will be handled after Brexit

How the MHRA will assess Marketing Authorisation Applications (MAA) for medicines referred under Article 29 if there's a no-deal Brexit.

0 comments Read Full Article

Detailed guide: Completed Paediatric Studies submission, processing and assessment in a no deal Brexit

Detailed guide: Completed Paediatric Studies   submission, processing and assessment in a no deal Brexit

Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs) in a no-deal Brexit.

0 comments Read Full Article

Guidance: Guideline on Paediatric Investigation Plans, waivers, deferrals and compliance check

Guidance: Guideline on Paediatric Investigation Plans, waivers, deferrals and compliance check

This guidance document from the MHRA provides information on the format and content of paediatric applications in the UK if there is a no-deal Brexit.

0 comments Read Full Article

Guidance: Guidance on pharmacovigilance procedures in the event of a no deal Brexit

Guidance: Guidance on pharmacovigilance procedures in the event of a no deal Brexit

This guidance summarises our approach to pharmacovigilance in the event of no-deal Brexit.

0 comments Read Full Article

Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices (MDA/2019/035)

Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices (MDA/2019/035)

Manufactured by Rocket Medical and NuSurgix – potential incompatibility between ethyl chloride spray and the device.

0 comments Read Full Article

Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices (MDA/2019/035)

Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices (MDA/2019/035)

Manufactured by Rocket Medical and NuSurgix – potential incompatibility between ethyl chloride spray and the device.

0 comments Read Full Article

Detailed guide: Good pharmacovigilance practice (GPvP)

Detailed guide: Good pharmacovigilance practice (GPvP)

Comply with good pharmacovigilance practice and prepare for an inspection.

0 comments Read Full Article

Detailed guide: Good pharmacovigilance practice (GPvP)

Detailed guide: Good pharmacovigilance practice (GPvP)

Comply with good pharmacovigilance practice and prepare for an inspection.

0 comments Read Full Article

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.

0 comments Read Full Article

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.

0 comments Read Full Article

Detailed guide: Registering new packaging information for medicines after Brexit

Detailed guide: Registering new packaging information for medicines after Brexit

How and when to register updated packaging and information leaflets when new marketing authorisations have been issued in a no-deal Brexit.

0 comments Read Full Article

Detailed guide: Registering new packaging information for medicines after Brexit

Detailed guide: Registering new packaging information for medicines after Brexit

How and when to register updated packaging and information leaflets when new marketing authorisations have been issued in a no-deal Brexit.

0 comments Read Full Article

Consultation outcome: MHRA consultation on EU exit no deal legislative proposals

Consultation outcome: MHRA consultation on EU exit no deal legislative proposals

This consultation seeks your views on how the Medicines and Healthcare products Regulatory Agency’s (MHRA) legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period. This consultation covers no-deal proposals on medicines, clinical trials and medical devices.

0 comments Read Full Article

Detailed guide: Apply to release a vaccine or a blood product to market

Detailed guide: Apply to release a vaccine or a blood product to market

Information for people who wish to apply to release a vaccine or a blood product to market in the UK.

0 comments Read Full Article

Guidance: Guidance on pharmacovigilance procedures in the event of a no deal Brexit

Guidance: Guidance on pharmacovigilance procedures in the event of a no deal Brexit

This guidance summarises our approach to pharmacovigilance in the event of no-deal Brexit.

0 comments Read Full Article

Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no deal Brexit

Detailed guide: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no deal Brexit

Pharmacovigilance system requirements if there is a no-deal Brexit.

0 comments Read Full Article

Guidance: Webinars: preparing to make submissions to the MHRA after Brexit

Guidance: Webinars: preparing to make submissions to the MHRA after Brexit

Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products about new MHRA systems you’ll need to use if there’s a no-deal Brexit.

0 comments Read Full Article

Regulation: Medical devices: UK notified bodies

Regulation: Medical devices: UK notified bodies

UK notified bodies listed under medical device directives.

0 comments Read Full Article

Detailed guide: MHRA Portal: register to submit forms

Detailed guide: MHRA Portal: register to submit forms

How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.

0 comments Read Full Article

Press release: Zantac – MHRA drug alert issued as GlaxoSmithKline recalls all unexpired stock

Press release: Zantac – MHRA drug alert issued as GlaxoSmithKline recalls all unexpired stock

The MHRA has issued an alert to heathcare professionals, as GlaxoSmithKline is recalling all unexpired stock of four types of Zantac, the medicine used to treat conditions such as heartburn and stomach ulcers.

0 comments Read Full Article

Class 2 Medicines recall: Zantac Injection 50mg/2ml, Zantac Syrup 150mg/10ml, Zantac Tablets 150mg, Zantac Tablets 300mg (EL (19)A 24)

Class 2 Medicines recall: Zantac Injection 50mg/2ml, Zantac Syrup 150mg/10ml, Zantac Tablets 150mg, Zantac Tablets 300mg (EL (19)A 24)

GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.

0 comments Read Full Article

Recent Comments

Follow Us on Twitter

Share This


Enjoyed this? Why not share it with others if you've found it useful by using one of the tools below: