Updated warnings for botulinum toxin products following rare cases of botulism
The MHRA is strengthening safety warnings for all botulinum toxin type A products, following reports of rare cases of botulism linked to their use.
UK MHRA
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UK MHRA
UK MHRA is an official public source that HealthSignal monitors for Pharmaceuticals, Medical Devices, General Regulatory. The most recent updates we have tracked from it are listed below, each normalised into our index and linked back to the original publication on the source's own website.
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UK-donor plasma given go-ahead for new medicines
Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of UK‑donor plasma for five high‑priority plasma-derived medicinal products.
UK MHRAClinical trials for medicines: Clinical Trials Regulations transitional arrangements
Guidance on transitional arrangements for the Clinical Trials Regulations.
UK MHRABotulinum toxin type A products: updated warnings regarding risk of iatrogenic botulism
Cases of iatrogenic botulism have been reported following the therapeutic or cosmetic use of botulinum toxin containing products where the toxin’s effect extends beyond the area of treatment. Patients should seek imme...
UK MHRAGuidance: International Recognition Procedure
How to use the procedure for medicines licensing applications.
UK MHRAField Safety Notices: 6 to 10 July 2026
List of Field Safety Notices from 6 to 10 July 2026.
UK MHRAGuidance: In vitro diagnostic point-of-care test devices
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
UK MHRAClass 2 Medicines Recall: Beckton Dickson UK Ltd, ChloraPrep 1mL applicator, EL(26)A/34
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators due to a potential breach of sterility in the packaging process.
UK MHRASemaglutide (Wegovy) approved to treat form of liver disease
The semaglutide injection has been approved to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis.
UK MHRAGuidance: Best practice in the labelling and packaging of medicines
This guidance explains the legal framework for labelling and packaging as described in UK legislation and gives best practice for producing medicines labelling and packaging.
UK MHRAGuidance: Submit changes to labels and Patient Information Leaflets as a self-certification
Guidance for submitting changes to labels and Patient Information Leaflets (PILs) as a self-certification.
UK MHRAMaking regulation a catalyst, not a barrier, for UK life sciences
MHRA CEO argues that for the UK’s long-term health and prosperity, regulation should help lead, rather than follow, innovation
UK MHRAResearch: MHRA data requirements to support regulatory decision making
A regulator’s view on what the new UK Health Data Research Service must deliver.
UK MHRAGuidance: Warning statements for labels and leaflets of certain medicines
This guidance sets out the warning statements which should appear on the label and/or in the leaflet of certain medicines.
UK MHRAGuidance: Best practice guidance on patient information leaflets
This guidance sets out the legal framework for patient information leaflets as described in EU and national legislation and best practice in the area of information design.
UK MHRAField Safety Notices: 22 to 26 June 2026
List of Field Safety Notices from 22 to 26 June 2026.
UK MHRAClass 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution, EL(26)A/31
Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.
UK MHRAGuidance: Borderline products: medical devices and other products
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
UK MHRAGuidance: Innovation Accelerator
Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
UK MHRAGuidance: MHRA Innovation Accelerator
The Innovation Accelerator provides innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
UK MHRAClass 4 Medicines Defect Notification: Brancaster Pharma Limited, Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection, EL(26)A/30
Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
UK MHRAGuidance: MHRA Innovation Office: guidance and support
We can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.
UK MHRANotice: Register of authorised online sellers of medicines in Northern Ireland
This register contains all websites that are authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) to sell medicines online, in Northern Ireland.
UK MHRAField Safety Notices: 15 to 19 June 2026
List of Field Safety Notices from 15 to 19 June 2026.
UK MHRAWarning on promoting newly licensed prescription-only medicines and unlicensed medicines for weight management
The MHRA, Advertising Standards Authority, and the General Pharmaceutical Council have issued a warning to businesses seeking to promote newly authorised medicines, as well as those that do not yet have a marketing au...
UK MHRAClass 3 Medicines Recall: Orbit Pharma Limited, Cyclizine Lactate 50 mg/ml Solution for injection, EL(26)A/29
Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing ...
UK MHRALower dose needle-free allergy treatment approved for younger children
As with any medicine, the MHRA will keep the safety and effectiveness of the adrenaline nasal spray under close review.
UK MHRAFirst GLP-1 tablet for weight loss approved in the UK
Having met the MHRA’s rigorous standards of safety, quality and effectiveness, the semaglutide tablet has been approved in the UK for weight loss and weight management.
UK MHRAResearch: National Commission into the Regulation of AI in Healthcare: research, engagement and call for evidence findings
Findings from the National Commission into the Regulation of AI in Healthcare's call for evidence and wider research and engagement activities.
UK MHRANipocalimab (Imaavy) authorised to treat adults and adolescents with generalised myasthenia gravis
As with all medicines, the MHRA will keep the safety and effectiveness of Nipolcalimab under close review.
UK MHRAGuidance: AI Airlock Sandbox Phase 2 Programme Report
The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
UK MHRAAdjuvanted trivalent influenza vaccine authorised for adults aged 50 and over
The adjuvanted trivalent influenza vaccine works by stimulating the immune system to produce its own protection against flu.
UK MHRAClass 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe, EL(26)A/27
Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed fo...
UK MHRAClass 2 Medicines Recall: Becton Dickinson UK Ltd, ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators, EL(26)A/26
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility in the packaging process.
UK MHRARilzabrutinib authorised to treat adults with immune thrombocytopenia when prior treatments have been insufficient
As with any medicine, the MHRA will keep the safety and effectiveness of rilzabrutinib under close review.
UK MHRAPrecautionary recall of blood pressure medication (Crescent Pharma Limited Ramipril 2.5mg capsules) after packaging error
Patients taking Crescent Pharma Limited Ramipril 2.5mg capsules are advised to check their packaging for batch number GR155023 and contact their pharmacy if any blister strips inside are labelled as Ramipril 10mg.
UK MHRAClass 2 Medicines Recall: Crescent Pharma Limited, Ramipril 2.5 mg Capsules, EL(26)A/25
Crescent Pharma Limited is initiating a precautionary recall of one batch of Ramipril 2.5 mg Capsules following the identification of a potential packaging error at the manufacturing site.
UK MHRADraft rare disease therapies regulatory framework
MHRA are seeking feedback on a proposed framework for rare disease therapies.
UK MHRAKimal Procedure Packs containing recalled components: Namic Angiographic Syringe with the risk of syringe disconnection; Namic Manifolds with the risk of foreign particulates. Important guidance for use in emergency situations (DSI/2026/002)
Medline Industries LP and Kimal PLC have identified safety issues with the Namic Angiographic Control Syringes with RA and Namic White Star Off Handle Manifold devices, and have issued field safety notices to affected...
UK MHRAField Safety Notices: 11 to 15 May 2026
List of Field Safety Notices from 11 to 15 May 2026.
UK MHRAProfessor Joann Rhodes: The Rules Need to Bend – Why Flexible Policies and Real Partnership are the Keys to unlocking Life Sciences Potential
Innovation doesn’t wait for the rules to catch up. The question is whether we can build a system agile and flexible enough to keep pace.
UK MHRAMHRA approves beremagene geperpavec (Vyjuvek) for the treatment of dystrophic epidermolysis bullosa
As with any medicine, the MHRA will keep the safety and effectiveness of Vyjuvek under close review.
UK MHRAField Safety Notices: 27 April to 1 May 2026
List of Field Safety Notices from 27 April to 1 May 2026.
UK MHRAMHRA strengthens safety warnings for finasteride and dutasteride
Updated safety advice has been issued to strengthen warnings about potential psychiatric and sexual dysfunction linked to finasteride and to provide precautionary advice on dutasteride.
UK MHRAMHRA opens UK-wide consultation on redefining gene therapies
To future-proof the sector and ensure regulation keeps up with scientific and technological developments, the MHRA is consulting on proposed changes to how gene therapies are defined in UK legislation.
UK MHRA
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